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| Name | Class |
|---|---|
| Tbilisi State Medical University | OTHER |
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The study purposed to learn how clopidogrel-based antiplatelet treatment for preventing adverse cardiovascular events after ePCI works in chronic coronary artery disease when guided by personal genetic characteristics for drug metabolism.
The study aimed to answer two research questions:
After obtaining the informed consent eligible study participants screened by inclusion and exclusion criteria were randomized and allocated into two groups:
The experimental group participants underwent CYP2C19 genotyping. Study participants with CYP2C19 normal function alleles (NFA) *2, *3 genotypes constituted the separate experimental arm and received clopidogrel-based preventive antiplatelet treatment.
Participants with CYP2C19 *2 and *3 loss of function (LoF) alleles were allocated to the separate experimental group and received preventive antiplatelet treatment alternative to clopidogrel.
Study participants who had not undergone CYP2C19 genotyping and received conventional preventive antiplatelet treatment with clopidogrel were assigned as active comparators.
All participants in the experimental and comparator groups underwent standard clinical investigations by current guideline recommendations for:
The main research outcome measures include:
The concept of the study is based on current evidence from multiple genetic and clinical studies. At this stage of development preventive treatment of chronic coronary artery disease after ePCI is challenged by risks related to multi-morbidity, recurrent MACCEs and bleeding. Scientific evidence broadly supports pharmacogenetic approaches for routine use of P2Y12 inhibitors (clopidogrel or alternative). Clopidogrel remains the most commonly used P2Y12 inhibitor in the post-ePCI settings. Along with disease-related and co-morbid factors treatment effects are influenced by the variability of the CYP2C19 genotype in the population, which significantly increases the risk of MACCE in loss of function allele (LoF) carriers even with conventional clopidogrel treatment. To improve treatment, a pharmacogenetic expediency model for drug selection is introduced. CYP2C19 allele genotype-guided clopidogrel or an alternative P2Y12 inhibitor treatment is based on robust evidence.
The study aimed to learn the comparative benefits of CYP2C19 genotype-guided versus conventional clopidogrel treatment selection applied in real clinical practice for preventing adverse cardiovascular events after ePCI in chronic coronary artery disease.
For this purpose, the randomized parallel-group controlled study for CYP2C19 genotype-guided clopidogrel treatment outcomes evaluation for chronic coronary artery disease after the ePCI in real-world practice was conducted.
The study addressed research-specific objectives:
forming and random allocating of participants into study arms for CYP2C19 allele genotype-guided versus conventional clopidogrel treatment,
ensuring RT-PCR based assay for CYP2C19 *2, *3 LoF alleles detection in randomly selected study participants and forming the experimental study groups,
characterizing clinical traits of study participants and observing adverse clinical events during the 12-month course of study intervention treatment;
evaluating the clinical and non-clinical study outcomes. Following the completion of the informed consent, 283 patients eligible for inclusion and exclusion criteria have been enrolled in the study and randomly allocated into two groups.
83 participants created the control group. They did not undergo CYP2C19 genotyping and received conventional antiplatelet treatment based on clopidogrel.
200 participants were tested for CYP2C19 *2, *3 allele genotype. 157 of those who revealed normal CYP2C19 *2, *3 allele genotype received conventional preventive antiplatelet treatment based on clopidogrel and created a separate experimental arm.
43 participants who revealed CYP2C19 *2, *3 LoF allele genotype required preventive antiplatelet treatment alternative to clopidogrel - based on ticagrelor or prasugrel were allocated into another separate experimental arm and assigned as the perspective arm for further study.
Before inclusion, informed consent was obtained from all study participants (or their legal representatives).
The randomization and study arm allocation processes were blinded for participants, healthcare teams providing medical care and study outcomes assessors. Nevertheless, after randomization and genetic testing, CYP2C19 allele genotyping results were disclosed to the medical care team and study participants to make ongoing clinical management safe and transparent but remained blinded for study outcomes assessors.
RT-PCR-based laboratory assay for CYP2C19 *2, *3 alleles genotyping was carried out only once after randomization for each study participant allocated into the experimental group. Tests were performed in the diagnostic laboratory of Vistamedi Ltd served as the central study laboratory.
The laboratory test report was provided to the authenticated investigator and as well as participant and entered in the study data report form.
Regular healthcare teams conducted clinical management of study participants in a real practice environment including medication treatment under conventional guideline recommendations were detected and initially reported major adverse cardiovascular outcomes, other adverse events, or additional clinical conditions diagnosed or study-related circumstances emerged through the study follow-up period up to the end of the study. Study participants (or their legal representatives) were also allowed to report adverse clinical outcomes, events or emerging circumstances.
For a study participant, the expected end of the study is defined as the end date of the 12-month follow-up from the date of the index ePCI. However, in the case of the clinical endpoint which corresponded to and defined the study outcome measure, the date of such endpoint event was determined as the end of the study, even if earlier than 12 months from the index ePCI.
The study participant could terminate participation by his or her independent decision, from any time of the research and for any reason, which could or could not be established.
Early withdrawal of a participant from the study was considered reasonable if there was repeated non-adherence to the treatment of study interest, rather than sporadic, or when there was preferred to terminate treatment based on the justified best interests of the participant.
Clinical outcomes conventionally defined by the Standardized Data Collection for Cardiovascular Trials Initiative (SCTI), the US Food and Drug Administration (FDA), the Academic Research Consortium for High Bleeding Risk (ARC-HBR) and WHO have been measured by clinical endpoints developed over the course of clinical cases.
Certain elements of the Coronary Revascularization Outcome Questionnaire (CROQ) and Patient-Reported Outcomes Measurement Information System®-Plus-Heart Failure profile were used for measuring of Patient-Reported Outcomes (PROs).
Study results were also analyzed using other non-clinical outcome measures that characterized the effectiveness of СYP2C19 genotype-guided P2Y12 inhibitor treatment utilization in real practice.
Data from each study participant were entered into a CRF, the form of which was the same for all participants and study centers.
Study data are collected, stored, and processed into a custom-designed electronic database. Identifiers, study variables and record data are validated with codes to ensure personal data protection.
Personal data, code keys and definitions, and research data are warehoused in separate databases. Only authenticated researchers have access to them. Research data collection centers do not have an internet connection or any other access to the database files.
Study data processing is only allowed by the study procedures given in the study protocol.
After the data collection, the database containing the personal data of the study participants will be deleted.
The de-identified electronic database will be stored after the end of the study for further research purposes for an indefinite period.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| Normal Metabolizers of Clopidogrel | Experimental | 157 study participants diagnosed with chronic coronary artery disease who had undergone elective PCI, tested with CYP2C19 genotyping and identified as NFA *2, *3 carriers. |
|
| Passive Metabolizers of Clopidogrel | Experimental | 43 study participants diagnosed with chronic coronary artery disease who had undergone elective PCI, tested with CYP2C19 genotyping, identified as LoF *2, *3 alleles carriers. |
|
| Unspecified Metabolizers of Clopidogrel | Active Comparator | 83 participants diagnosed with chronic coronary artery disease who had undergone elective PCI were allocated to the arm through the randomization, without CYP2C19 genotyping and clopidogrel metabolism phenotype have not been specified. |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| CYP2C19 Genotype-Guided Clopidogrel Treatment | Other | Clopidogrel as a component of preventive antiplatelet treatment such as double antiplatelet treatment (DAPT), or an antiplatelet drug (clopidogrel) combined with the non-vitamin K antagonist oral anticoagulants (NOAC), incl. triple antiplatelet treatment (Aspirin, Clopidogrel and a NOAC), or antiplatelet monotherapy (Clopidogrel). |
| Measure | Description | Time Frame |
|---|---|---|
| Number of Study Participants Who Died From Any Cause (Death From Any Cause) | The event of death from any cause reported by the physician according to the WHO Clinical criteria for the determination of death or the incident declared by the caregiver of the patient and checked for appropriateness in hospital registries or the national death registry within the study follow-up period, from the date of study enrollment until the date of the event. | within a 12-month of the study follow-up |
| Number of Study Participants Who Died From Any Cardiovascular Cause (Death From Cardiovascular Cause) | The event of death from any cardiovascular cause reported by the physician according the SCTI (Standardized Data Collection for Cardiovascular Trials Initiative) definitions or the incident declared by the caregiver of the patient and checked for appropriateness in hospital registries or the national death registry within the study follow-up period, from the date of study enrollment until the date of the event. | within a 12-month of the study follow-up |
| Number of Study Participants Who Died From Non-cardiovascular Causes (Death From Non-cardiovascular Cause) | The event of death from a non-cardiovascular cause reported by the physician or the incident declared by the caregiver of the patient and checked for appropriateness in hospital registries or the national death registry within the study follow-up period, from the date of study enrollment until the date of the event. | within a 12-month of the study follow-up |
| Measure | Description | Time Frame |
|---|---|---|
| Number of Study Participants Who Experienced Non-fatal Myocardial Infarction (Non-fatal Myocardial Infarction) | The clinical event of the non-fatal myocardial infarction detected during the study follow-up period and assessed by the 2012 Third Universal Definition of Myocardial Infarction as recommended by the SCTI (Standardized Data Collection for Cardiovascular Trials Initiative) definitions during the study follow-up period, from the date of study enrollment until the date of the event. |
| Measure | Description | Time Frame |
|---|---|---|
| Number of Study Cases in Each Arm With a Composite of Death From Any Cause, Non-fatal Myocardial Infarction, Stroke/TIA, or Major Bleeding Within the Study Follow-up (Net Adverse Clinical Events - NACEs) | Net adverse clinical event (NACE) is assessed via measuring and putting together death from any cause, non-fatal myocardial infarction, stroke/TIA, or major bleeding (BARC type 3, 5) as potential outcomes for every studied case during the study follow-up period, from the date of study enrollment until the date of the event. |
Inclusion Criteria:
Exclusion Criteria:
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| Name | Affiliation | Role |
|---|---|---|
| Levan Jijeishvili, MD, MPH | Vistamedi Ltd., Tbilisi Georgia | Study Director |
| Konstantine Liluashvili, MD., PH.D. | Tbilisi State Medical University | Principal Investigator |
| Tornike Batavani, MD, MPH | Vistamedi Ltd. Tbilisi, Georgia | Study Chair |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| 1st University Clinic of the Tbilisi State Medical University | Tbilisi | Georgia | ||||
| Cardio Expert Ltd., Clinic Cardio |
| PubMed Identifier | Type | Citation | Retractions |
|---|---|---|---|
| 35016208 | Background | Timmis A, Vardas P, Townsend N, Torbica A, Katus H, De Smedt D, Gale CP, Maggioni AP, Petersen SE, Huculeci R, Kazakiewicz D, de Benito Rubio V, Ignatiuk B, Raisi-Estabragh Z, Pawlak A, Karagiannidis E, Treskes R, Gaita D, Beltrame JF, McConnachie A, Bardinet I, Graham I, Flather M, Elliott P, Mossialos EA, Weidinger F, Achenbach S; Atlas Writing Group, European Society of Cardiology. European Society of Cardiology: cardiovascular disease statistics 2021. Eur Heart J. 2022 Feb 22;43(8):716-799. doi: 10.1093/eurheartj/ehab892. | |
| Background | N. Mikaia, L. Jijeishvili, K. Liluashvili, M. Sebiskveradze, Z. Kavtaria, L. Bakashvili, M. Okujava, Implementation of molecular markers targeting thrombosis-related conditions in the real clinical practice, Clinica Chimica Acta, Volume 558, Supplement 1, 2024, 119263, ISSN 0009-8981, https://doi.org/10.1016/j.cca.2024.119263. (https://www.sciencedirect.com/science/article/pii/S0009898124015043) | ||
| 33551797 |
| Label | URL |
|---|---|
| Clopidogrel, Drug Usage Statistics, United States, 2013 - 2022 | View source |
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After deidentification of the data records, the deidentified IPD used for the results section intended for article publication will be shared.
The data set will contain certain demographics, risk factors, cardiovascular morbidity, co-morbidity, coronary angiography, doppler-echocardiography, medication selection records of intervention and control group patients as well as CYP2C19 gene *2, *3 allele profile of the intervention group patients.
Meta-data in the form of tables, figures, text or appendices will be available as well.
The study protocol, variable and recorded data coding, statistical analysis plan and informed consent form will be shared as well.
The IPD will be available 1 month following the publication of the article containing study results. The anticipated date of final data collection for the primary outcome measures is March 2025. At this time two manuscripts for publication submission are expected to be completed and the study IPD will be available for sharing.
Before this time supporting information will be shared. After sharing IPD, supporting information will be available for researchers in the field related to this study.
The study IPD will remain available for sharing 36 months after the article publication.
IPD and supportive information will be accessible for researchers and investigators who will provide a methodologically sound proposal and whose proposed use of the data will be approved by the independent review and ethics boards. The proposal should display aims and types of IPD analysis, show intentions for IPD meta-analysis.
Possibility and appropriateness of the IPD for sharing should be confirmed by the National Personal Data Protection Service of Georgia.
The proposal can be submitted up to 36 months following the study article publication. After 36 months the IPD will be available in the VistaMedi Ltd data warehouse but without investigators support other than deposited meta-data.
Information regarding proposal submitting, IPD accessing procedures and more detailed plan for sharing IPD, Study Protocol, Statistical Analysis Plan (SAP), Informed Consent Form (ICF) and Variable Data codes will be released on the VistaMedi Ltd official website http://vistamedi.ge/en/.
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In total, 330 study participants were screened for participation, and 283 who met the study eligibility criteria and signed informed consent forms for study participation were recruited.
The study investigating CYP2C19 genotype-guided clopidogrel treatment models was conducted by Vistamedi Ltd. (Tbilisi, Georgia) collecting data from out-patient and hospital health care facilities of four clinical cardiology centers in Tbilisi, Georgia.
The active recruitment process started after obtaining Institutional Review Boars (IRB) approval of the study protocol and continued for 12 months.
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| ID | Title | Description |
|---|---|---|
| FG000 | Normal Metabolizers of Clopidogrel | 157 study participants diagnosed with chronic coronary artery disease who had undergone elective PCI, tested with CYP2C19 genotyping and identified as NFA *2, *3 carriers. |
| FG001 | Passive Metabolizers of Clopidogrel |
| Title | Milestones | Reasons Not Completed | |||||
|---|---|---|---|---|---|---|---|
| Overall Study |
|
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| Type | Includes Protocol | Includes SAP | Includes ICF | Document Label | Document Date | Document Uploaded Date | Document File Name |
|---|---|---|---|---|---|---|---|
| Prot_SAP | Yes | Yes | No | Study Protocol and Statistical Analysis Plan | Jun 7, 2023 |
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To evaluate CYP2C19 allele genotype-guided clopidogrel treatment outcomes after the ePCI study participants were randomly allocated into parallel study arms. Experimental arm participants have undergone CYP2C19 genotyping. Carriers of normal *2, *3 alleles - "normal metabolizers" phenotype separated as the experimental arm and participants randomly allocated in the comparators arm without CYP2C19 genotyping - the "unspecified metabolizers" phenotype, have been intervened with clopidogrel-based preventive antiplatelet treatment. Carriers of LoF *2, *3 alleles - the "poor metabolizers" phenotype, have been separated in the experimental arm, assigned as the additional comparators and intervened with preventive antiplatelet treatment alternative to clopidogrel. Clinical and non-clinical outcome measures are expected to be compared between parallel study groups.
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| CYP2C19 Genotype Guided Antiplatelet Treatment Alternative to Clopidogrel | Other | An antiplatelet drug alternative to clopidogrel in conventional dosing regimen, as a component of preventive antiplatelet treatment, such as double antiplatelet treatment (DAPT) with ticagrelor or prasugrel, or prasugrel combined with the non-vitamin K antagonist oral anticoagulants (NOAC), or antiplatelet monotherapy (ticagrelor, or prasugrel). |
|
| The Conventional Clopidogrel Treatment | Other | Clopidogrel as a component of preventive antiplatelet treatment such as double antiplatelet treatment (DAPT), or clopidogrel combined with the non-vitamin K antagonist oral anticoagulants (NOAC), incl. triple antiplatelet treatment (Aspirin, Clopidogrel and a NOAC), or antiplatelet monotherapy (Clopidogrel). |
|
| within a 12-month of the study follow-up |
| Number of Study Participants Who Experienced Unstable Angina or Angina Requiring Hospitalization (Unstable Angina) | The clinical event corresponding to the unstable angina, or angina that requires hospitalization detected during the study follow-up period and assessed by the SCTI (Standardized Data Collection for Cardiovascular Trials Initiative) definitions during the study follow-up period, from the date of study enrollment until the date of the event. | within a 12-month of the study follow-up |
| Number of Study Participants Who Experienced a Stroke or Transitory Cerebral Ischemic Event Within the Study Follow-up Period (Stroke or TIA) | The clinical event of the stroke or transitory ischemic attack detected during the study follow-up period and assessed by the SCTI (Standardized Data Collection for Cardiovascular Trials Initiative) definitions for Stroke and Transient Ischemic Attack during the study follow-up period, from the date of study enrollment until the date of the event. | within a 12-month of the study follow-up |
| Number of Study Participants Who Experienced Major Bleeding (Major Bleeding) | The clinical event of major bleeding detected during the study follow-up period and assessed by the ARC-HBR (Academic Research Consortium for High Bleeding Risk) definitions as BARC type 3, 5 of bleeding during the study follow-up period, from the date of study enrollment until the date of the event. | within a 12-month of the study follow-up |
| Number of Study Participants Who Experienced Non-major Bleeding (Non-major Bleeding) | The clinical event of major bleeding detected during the study follow-up period and assessed by the ARC-HBR (Academic Research Consortium for High Bleeding Risk) definitions as BARC type 1 of bleeding during the study follow-up period, from the date of study enrollment until the date of the event. | within a 12-month of the study follow-up |
| Number of Study Participants Who Experienced Heart Failure Event (Heart Failure Event) | The clinical event of heart failure that requires hospitalization detected during the study follow-up period and assessed by the SCTI (Standardized Data Collection for Cardiovascular Trials Initiative) definitions during the study follow-up period, from the date of study enrollment until the date of the event. | within a 12-month of the study follow-up |
| Number of Study Participants Who Experienced Percutaneous Coronary Intervention or Coronary Artery Bypass-grafting (Repeated Coronary Revascularization) | The clinical event of any repeated coronary revascularization: percutaneous coronary intervention or coronary artery bypass-grafting detected during the study follow-up period and assessed by the SCTI (Standardized Data Collection for Cardiovascular Trials Initiative) definitions during the study follow-up period, from the date of study enrollment until the date of the event. | within a 12-month of the study follow-up |
| within a 12-month of the study follow-up |
| Number of Study Cases in Each Study Arm With a Composite of Death From Any Cause, Myocardial Infarction, or Stroke/TIA Within the Study Follow-up (Major Adverse Cardiac or Cerebral Events - MACCEs) | Major adverse cardiac or cerebral event (MACCE) is assessed by measuring and putting together death from cardiovascular cause, non-fatal myocardial infarction, or stroke/TIA as potential outcomes for every studied case during the study follow-up period, from the date of study enrollment until the date of the event. | within a 12-month of the study follow-up |
| Number of Study Cases With Certain Antiplatelet Treatment Selection (Dual Antiplatelet Treatment, Triple Antiplatelet Treatment, Combined Antiplatelet and Anticoagulant, or Antiplatelet Monotherapy) in Each Study Arm | The number and percentage (%) of each arm of study participants treated with dual antiplatelet treatment, triple antiplatelet treatment, antiplatelet and non-vitamin K antagonist oral anticoagulant combination, or antiplatelet monotherapy | within a 12-month of the study follow-up |
| The Number of Study Cases With Certain Antiplatelet Medication (Aspirin, Clopidogrel, P2Y12 Inhibitor, Alternative to Clopidogrel, or A Non-vitamin K Antagonist Oral Anticoagulant (NOAC)) Prescription | The number and percentage (%) of study participants treated with a certain antiplatelet drug - aspirin, clopidogrel, P2Y12 inhibitor alternative to clopidogrel, or a non-vitamin K antagonist oral anticoagulant (NOAC) in each study arm | within a 12-month of the study follow-up |
| The Number of Study Cases With Lipid-lowering Medication (Statin, or Combination With Ezetimibe, or Ezetimibe and PCSK9i) Prescription | The number and percentage (%) of study participants treated with lipid-lowering medication - statin, or combined statin and ezetimibe, or statin, ezetimibe and PCSK9i in each study arm | within a 12-month of the study follow-up |
| The Number of Study Cases With Hypoglycemic Medication Prescription | The number and percentage (%) of study participants treated with certain hypoglycemic medication - insulin, sodium-glucose cotransporter-2 (SGLT2) inhibitor, metformin, glucagon-like peptide-1 (GLP-1) receptor agonist, or dipeptidyl peptidase IV (DPP IV) inhibitor in each study arm | within a 12-month of the study follow-up |
| The Number of Study Cases With Other Common Evidence-Based Medication Prescription for Cardiovascular Risk Reduction | The number and percentage (%) of study participants treated with other common evidence-based medication for cardiovascular risk reduction - angiotensin converting enzyme inhibitor (ACEi), angiotensin receptor blocker (ARB), angiotensin receptor neprilysin inhibitor (ARNi), beta adrenergic blocker, loop diuretic, mineralocorticoid receptor antagonist (MCRA), thiazide diuretic, calcium channel blocker, anti-arrhythmic drug or ivabradine in each study arm | within a 12-month of the study follow-up |
| Number of Study Participants Who Reported Their Health Status as Good or Satisfactory; or With the Appearance of CVD Symptoms; or With a Significant Inability to Self-care (Patient-Reported Health Status) | The health status reported by the patient as: a) good or satisfactory; b) with the appearance of CVD symptoms; c) a significant inability to self-care ranked with severity degree of patient well-being, symptom burden, or ability for self-care, which is assessed according to the routine health related quality of life questionnaire definitions. | at 3, 6 and 12-month of the study follow-up |
| Number of Study Participants Self-reported Angina Not Required Hospitalization (Patient-Reported Angina Not Required Hospitalization) | The participant-reported last week episode of chest pain, or any discomfort, shortness of breath, or tightness in the chest due to angina not required hospitalization assessed by the CROQ (Coronary Revascularization Outcome Questionnaire) definitions. | at 3, 6 and 12-month of the study follow-up |
| Number of Study Participants Reported Last Week's Shortness of Breath Due to Heart Failure Not Requiring Hospitalization (Patient-Reported Heart Failure Severity) | The participant reported last week's shortness of breath due to mild physical activity or at rest not requiring hospitalization assessed by the PROMIS®-Plus-HF (Patient-Reported Outcomes Measurement Information System®-Plus-Heart Failure) profile definitions. | at 3, 6 and 12 months of the study follow-up |
| Tbilisi |
| Georgia |
| T. Oragvelidze Cardiology Center | Tbilisi | Georgia |
| Tbilisi Institute of Medicine | Tbilisi | Georgia |
| Background |
| Zhang Y, Shi XJ, Peng WX, Han JL, Lin BD, Zhang R, Zhang YN, Yan JL, Wei JJ, Wang YF, Chen SW, Nan N, Fang ZW, Zeng Y, Lin Y. Impact of Implementing CYP2C19 Genotype-Guided Antiplatelet Therapy on P2Y12 Inhibitor Selection and Clinical Outcomes in Acute Coronary Syndrome Patients After Percutaneous Coronary Intervention: A Real-World Study in China. Front Pharmacol. 2021 Jan 20;11:582929. doi: 10.3389/fphar.2020.582929. eCollection 2020. |
| 32678355 | Background | Beitelshees AL, Stevenson JM, El Rouby N, Dillon C, Empey PE, Fielstein EM, Johnson JA, Limdi NA, Ong HH, Franchi F, Angiolillo DJ, Peterson JF, Rosenman MB, Skaar TC, Tuteja S, Cavallari LH; IGNITE Pharmacogenetics Working Group. Evaluating the extent of reusability of CYP2C19 genotype data among patients genotyped for antiplatelet therapy selection. Genet Med. 2020 Nov;22(11):1898-1902. doi: 10.1038/s41436-020-0894-2. Epub 2020 Jul 17. |
| 34936903 | Background | Galli M, Franchi F, Rollini F, Angiolillo DJ. Role of platelet function and genetic testing in patients undergoing percutaneous coronary intervention. Trends Cardiovasc Med. 2023 Apr;33(3):133-138. doi: 10.1016/j.tcm.2021.12.007. Epub 2021 Dec 20. |
| 29700074 | Background | Leopold JA, Loscalzo J. Emerging Role of Precision Medicine in Cardiovascular Disease. Circ Res. 2018 Apr 27;122(9):1302-1315. doi: 10.1161/CIRCRESAHA.117.310782. |
| 31479209 | Background | Claassens DMF, Vos GJA, Bergmeijer TO, Hermanides RS, van 't Hof AWJ, van der Harst P, Barbato E, Morisco C, Tjon Joe Gin RM, Asselbergs FW, Mosterd A, Herrman JR, Dewilde WJM, Janssen PWA, Kelder JC, Postma MJ, de Boer A, Boersma C, Deneer VHM, Ten Berg JM. A Genotype-Guided Strategy for Oral P2Y12 Inhibitors in Primary PCI. N Engl J Med. 2019 Oct 24;381(17):1621-1631. doi: 10.1056/NEJMoa1907096. Epub 2019 Sep 3. |
| 28854078 | Background | Vyas A, Bash LD, Patel MD, Simpson RJ Jr. Changes in Treatment Patterns and Incremental Health Care Utilization Due to P2Y12-Associated Complications in Patients with Acute Coronary Syndrome. J Manag Care Spec Pharm. 2017 Sep;23(9):947-956. doi: 10.18553/jmcp.2017.23.9.947. |
| 26108379 | Background | Johnson SG, Gruntowicz D, Chua T, Morlock RJ. Financial Analysis of CYP2C19 Genotyping in Patients Receiving Dual Antiplatelet Therapy Following Acute Coronary Syndrome and Percutaneous Coronary Intervention. J Manag Care Spec Pharm. 2015 Jul;21(7):552-7. doi: 10.18553/jmcp.2015.21.7.552. |
| 35699175 | Background | Madan M, Abbott JD, Lennon R, So DYF, MacDougall AM, McLaughlin MA, Murthy V, Saw J, Rihal C, Farkouh ME, Pereira NL, Goodman SG; TAILOR-PCI Investigators *. Sex-Specific Differences in Clinical Outcomes After Percutaneous Coronary Intervention: Insights from the TAILOR-PCI Trial. J Am Heart Assoc. 2022 Jun 21;11(12):e024709. doi: 10.1161/JAHA.121.024709. Epub 2022 Jun 14. |
| 32243053 | Background | Nazir S, Ahuja KR, Virk HUH, Elzanaty A, Waheed TA, Changal KH, Wohlfarth K, Lakhter V, Grande RD, Eltahawy EA. A meta-analysis of efficacy and safety of genotype-guided versus standard of care treatment strategies in selecting antiplatelet therapy in patients with acute coronary syndrome. Catheter Cardiovasc Interv. 2021 Apr 1;97(5):788-794. doi: 10.1002/ccd.28860. Epub 2020 Apr 3. |
| 36082121 | Background | Nguyen AB, Cavallari LH, Rossi JS, Stouffer GA, Lee CR. Evaluation of race and ethnicity disparities in outcome studies of CYP2C19 genotype-guided antiplatelet therapy. Front Cardiovasc Med. 2022 Aug 23;9:991646. doi: 10.3389/fcvm.2022.991646. eCollection 2022. |
| 35155631 | Background | Jourdi G, Godier A, Lordkipanidze M, Marquis-Gravel G, Gaussem P. Antiplatelet Therapy for Atherothrombotic Disease in 2022-From Population to Patient-Centered Approaches. Front Cardiovasc Med. 2022 Jan 28;9:805525. doi: 10.3389/fcvm.2022.805525. eCollection 2022. |
| 31116395 | Background | Urban P, Mehran R, Colleran R, Angiolillo DJ, Byrne RA, Capodanno D, Cuisset T, Cutlip D, Eerdmans P, Eikelboom J, Farb A, Gibson CM, Gregson J, Haude M, James SK, Kim HS, Kimura T, Konishi A, Laschinger J, Leon MB, Magee PFA, Mitsutake Y, Mylotte D, Pocock S, Price MJ, Rao SV, Spitzer E, Stockbridge N, Valgimigli M, Varenne O, Windhoevel U, Yeh RW, Krucoff MW, Morice MC. Defining high bleeding risk in patients undergoing percutaneous coronary intervention: a consensus document from the Academic Research Consortium for High Bleeding Risk. Eur Heart J. 2019 Aug 14;40(31):2632-2653. doi: 10.1093/eurheartj/ehz372. |
| 28110296 | Background | Palmerini T, Della Riva D, Benedetto U, Bacchi Reggiani L, Feres F, Abizaid A, Gilard M, Morice MC, Valgimigli M, Hong MK, Kim BK, Jang Y, Kim HS, Park KW, Colombo A, Chieffo A, Sangiorgi D, Biondi-Zoccai G, Genereux P, Angelini GD, Pufulete M, White J, Bhatt DL, Stone GW. Three, six, or twelve months of dual antiplatelet therapy after DES implantation in patients with or without acute coronary syndromes: an individual patient data pairwise and network meta-analysis of six randomized trials and 11 473 patients. Eur Heart J. 2017 Apr 7;38(14):1034-1043. doi: 10.1093/eurheartj/ehw627. |
| 24067509 | Background | Aradi D, Storey RF, Komocsi A, Trenk D, Gulba D, Kiss RG, Husted S, Bonello L, Sibbing D, Collet JP, Huber K; Working Group on Thrombosis of the European Society of Cardiology. Expert position paper on the role of platelet function testing in patients undergoing percutaneous coronary intervention. Eur Heart J. 2014 Jan;35(4):209-15. doi: 10.1093/eurheartj/eht375. Epub 2013 Sep 25. No abstract available. |
| 37345589 | Background | Capodanno D, Angiolillo DJ. Personalised antiplatelet therapies for coronary artery disease: what the future holds. Eur Heart J. 2023 Aug 22;44(32):3059-3072. doi: 10.1093/eurheartj/ehad362. |
| 33515031 | Background | van der Sangen NMR, Rozemeijer R, Chan Pin Yin DRPP, Valgimigli M, Windecker S, James SK, Buccheri S, Ten Berg JM, Henriques JPS, Voskuil M, Kikkert WJ. Patient-tailored antithrombotic therapy following percutaneous coronary intervention. Eur Heart J. 2021 Mar 7;42(10):1038-1046. doi: 10.1093/eurheartj/ehaa1097. |
| 28294551 | Background | Cavallari LH, Beitelshees AL, Blake KV, Dressler LG, Duarte JD, Elsey A, Eichmeyer JN, Empey PE, Franciosi JP, Hicks JK, Holmes AM, Jeng L, Lee CR, Lima JJ, Limdi NA, Modlin J, Obeng AO, Petry N, Pratt VM, Skaar TC, Tuteja S, Voora D, Wagner M, Weitzel KW, Wilke RA, Peterson JF, Johnson JA. The IGNITE Pharmacogenetics Working Group: An Opportunity for Building Evidence with Pharmacogenetic Implementation in a Real-World Setting. Clin Transl Sci. 2017 May;10(3):143-146. doi: 10.1111/cts.12456. Epub 2017 Mar 14. No abstract available. |
| 31758664 | Background | El Rouby N, Alrwisan A, Langaee T, Lipori G, Angiolillo DJ, Franchi F, Riva A, Elsey A, Johnson JA, Cavallari LH, Winterstein AG. Clinical Utility of Pharmacogene Panel-Based Testing in Patients Undergoing Percutaneous Coronary Intervention. Clin Transl Sci. 2020 May;13(3):473-481. doi: 10.1111/cts.12729. Epub 2020 Jan 16. |
| 31664775 | Background | Davis BH, DeFrank G, Limdi NA, Harada S. Validation of the Spartan RXCYP2C19 Genotyping Assay Utilizing Blood Samples. Clin Transl Sci. 2020 Mar;13(2):260-264. doi: 10.1111/cts.12714. Epub 2019 Nov 29. |
| 29615454 | Background | Lee CR, Sriramoju VB, Cervantes A, Howell LA, Varunok N, Madan S, Hamrick K, Polasek MJ, Lee JA, Clarke M, Cicci JD, Weck KE, Stouffer GA. Clinical Outcomes and Sustainability of Using CYP2C19 Genotype-Guided Antiplatelet Therapy After Percutaneous Coronary Intervention. Circ Genom Precis Med. 2018 Apr;11(4):e002069. doi: 10.1161/CIRCGEN.117.002069. |
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| 34903548 | Background | Pilling LC, Turkmen D, Fullalove H, Atkins JL, Delgado J, Kuo CL, Kuchel GA, Ferrucci L, Bowden J, Masoli JAH, Melzer D. Analysis of CYP2C19 genetic variants with ischaemic events in UK patients prescribed clopidogrel in primary care: a retrospective cohort study. BMJ Open. 2021 Dec 13;11(12):e053905. doi: 10.1136/bmjopen-2021-053905. |
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| 29540324 | Background | Notarangelo FM, Maglietta G, Bevilacqua P, Cereda M, Merlini PA, Villani GQ, Moruzzi P, Patrizi G, Malagoli Tagliazucchi G, Crocamo A, Guidorossi A, Pigazzani F, Nicosia E, Paoli G, Bianchessi M, Comelli MA, Caminiti C, Ardissino D. Pharmacogenomic Approach to Selecting Antiplatelet Therapy in Patients With Acute Coronary Syndromes: The PHARMCLO Trial. J Am Coll Cardiol. 2018 May 1;71(17):1869-1877. doi: 10.1016/j.jacc.2018.02.029. Epub 2018 Mar 11. |
| 29102571 | Background | Cavallari LH, Lee CR, Beitelshees AL, Cooper-DeHoff RM, Duarte JD, Voora D, Kimmel SE, McDonough CW, Gong Y, Dave CV, Pratt VM, Alestock TD, Anderson RD, Alsip J, Ardati AK, Brott BC, Brown L, Chumnumwat S, Clare-Salzler MJ, Coons JC, Denny JC, Dillon C, Elsey AR, Hamadeh IS, Harada S, Hillegass WB, Hines L, Horenstein RB, Howell LA, Jeng LJB, Kelemen MD, Lee YM, Magvanjav O, Montasser M, Nelson DR, Nutescu EA, Nwaba DC, Pakyz RE, Palmer K, Peterson JF, Pollin TI, Quinn AH, Robinson SW, Schub J, Skaar TC, Smith DM, Sriramoju VB, Starostik P, Stys TP, Stevenson JM, Varunok N, Vesely MR, Wake DT, Weck KE, Weitzel KW, Wilke RA, Willig J, Zhao RY, Kreutz RP, Stouffer GA, Empey PE, Limdi NA, Shuldiner AR, Winterstein AG, Johnson JA; IGNITE Network. Multisite Investigation of Outcomes With Implementation of CYP2C19 Genotype-Guided Antiplatelet Therapy After Percutaneous Coronary Intervention. JACC Cardiovasc Interv. 2018 Jan 22;11(2):181-191. doi: 10.1016/j.jcin.2017.07.022. Epub 2017 Nov 1. |
| 32027168 | Background | AlMukdad S, Elewa H, Al-Badriyeh D. Economic Evaluations of CYP2C19 Genotype-Guided Antiplatelet Therapy Compared to the Universal Use of Antiplatelets in Patients With Acute Coronary Syndrome: A Systematic Review. J Cardiovasc Pharmacol Ther. 2020 May;25(3):201-211. doi: 10.1177/1074248420902298. Epub 2020 Feb 6. |
| 34995471 | Background | Tang B, Wang X, Wang X, Liu L, Ma Z. Genotype-Guided Antiplatelet Therapy Versus Standard Therapy for Patients with Coronary Artery Disease: An Updated Systematic Review and Meta-Analysis. J Pharm Pharm Sci. 2022;25:9-23. doi: 10.18433/jpps32140. |
| 26431961 | Background | Leucht S, Helfer B, Gartlehner G, Davis JM. How effective are common medications: a perspective based on meta-analyses of major drugs. BMC Med. 2015 Oct 2;13:253. doi: 10.1186/s12916-015-0494-1. |
| 35860051 | Background | Yamani N, Unzek S, Mankani MH, Almas T, Musheer A, Qamar H, Farooq S, Shahnawaz W, Fatima K, Figueredo V, Mookadam F. Does individualized guided selection of antiplatelet therapy improve outcomes after percutaneous coronary intervention? A systematic review and meta-analysis. Ann Med Surg (Lond). 2022 Jun 18;79:103964. doi: 10.1016/j.amsu.2022.103964. eCollection 2022 Jul. |
| 37045504 | Background | Lee SH, Jeong YH, Hong D, Choi KH, Lee JM, Park TK, Yang JH, Hahn JY, Choi SH, Gwon HC, Jeong MH, Kim BK, Joo HJ, Chang K, Park Y, Ahn SG, Suh JW, Lee SY, Cho JR, Her AY, Kim HS, Kim MH, Lim DS, Shin ES, Song YB; PTRG-DES Registry Investigators. Clinical Impact of CYP2C19 Genotype on Clopidogrel-Based Antiplatelet Therapy After Percutaneous Coronary Intervention. JACC Cardiovasc Interv. 2023 Apr 10;16(7):829-843. doi: 10.1016/j.jcin.2023.01.363. Epub 2023 Mar 8. |
| 37045502 | Background | Ingraham BS, Farkouh ME, Lennon RJ, So D, Goodman SG, Geller N, Bae JH, Jeong MH, Baudhuin LM, Mathew V, Bell MR, Lerman A, Fu YP, Hasan A, Iturriaga E, Tanguay JF, Welsh RC, Rosenberg Y, Bailey K, Rihal C, Pereira NL. Genetic-Guided Oral P2Y12 Inhibitor Selection and Cumulative Ischemic Events After Percutaneous Coronary Intervention. JACC Cardiovasc Interv. 2023 Apr 10;16(7):816-825. doi: 10.1016/j.jcin.2023.01.356. |
| 34154743 | Background | Stys TP, Gedela M, Gowda SN, Bares V, Fanta L, Petrasko M, Hajek C, Larson E, Stys AT. CYP2C19 genotype-directed P2Y12 inhibitor antiplatelet therapy normalizes risk for major adverse cardiovascular events after percutaneous coronary intervention. Indian Heart J. 2021 May-Jun;73(3):281-288. doi: 10.1016/j.ihj.2021.03.004. Epub 2021 Mar 17. |
| 30998396 | Background | Pereira NL, Rihal CS, So DYF, Rosenberg Y, Lennon RJ, Mathew V, Goodman SG, Weinshilboum RM, Wang L, Baudhuin LM, Lerman A, Hasan A, Iturriaga E, Fu YP, Geller N, Bailey K, Farkouh ME. Clopidogrel Pharmacogenetics. Circ Cardiovasc Interv. 2019 Apr;12(4):e007811. doi: 10.1161/CIRCINTERVENTIONS.119.007811. |
| 31928229 | Background | Tuteja S, Glick H, Matthai W, Nachamkin I, Nathan A, Monono K, Carcuffe C, Maslowski K, Chang G, Kobayashi T, Anwaruddin S, Hirshfeld J, Wilensky RL, Herrmann HC, Kolansky DM, Rader DJ, Giri J. Prospective CYP2C19 Genotyping to Guide Antiplatelet Therapy Following Percutaneous Coronary Intervention: A Pragmatic Randomized Clinical Trial. Circ Genom Precis Med. 2020 Feb;13(1):e002640. doi: 10.1161/CIRCGEN.119.002640. Epub 2020 Jan 12. |
| 35034351 | Background | Lee CR, Luzum JA, Sangkuhl K, Gammal RS, Sabatine MS, Stein CM, Kisor DF, Limdi NA, Lee YM, Scott SA, Hulot JS, Roden DM, Gaedigk A, Caudle KE, Klein TE, Johnson JA, Shuldiner AR. Clinical Pharmacogenetics Implementation Consortium Guideline for CYP2C19 Genotype and Clopidogrel Therapy: 2022 Update. Clin Pharmacol Ther. 2022 Nov;112(5):959-967. doi: 10.1002/cpt.2526. Epub 2022 Feb 8. |
| 33568995 | Background | Abdullah-Koolmees H, van Keulen AM, Nijenhuis M, Deneer VHM. Pharmacogenetics Guidelines: Overview and Comparison of the DPWG, CPIC, CPNDS, and RNPGx Guidelines. Front Pharmacol. 2021 Jan 25;11:595219. doi: 10.3389/fphar.2020.595219. eCollection 2020. |
| 29799992 | Background | Dayoub EJ, Seigerman M, Tuteja S, Kobayashi T, Kolansky DM, Giri J, Groeneveld PW. Trends in Platelet Adenosine Diphosphate P2Y12 Receptor Inhibitor Use and Adherence Among Antiplatelet-Naive Patients After Percutaneous Coronary Intervention, 2008-2016. JAMA Intern Med. 2018 Jul 1;178(7):943-950. doi: 10.1001/jamainternmed.2018.0783. |
| 34670396 | Background | Parcha V, Heindl BF, Li P, Kalra R, Limdi NA, Pereira NL, Arora G, Arora P. Genotype-Guided P2Y12 Inhibitor Therapy After Percutaneous Coronary Intervention: A Bayesian Analysis. Circ Genom Precis Med. 2021 Dec;14(6):e003353. doi: 10.1161/CIRCGEN.121.003353. Epub 2021 Oct 21. |
| 32840598 | Background | Pereira NL, Farkouh ME, So D, Lennon R, Geller N, Mathew V, Bell M, Bae JH, Jeong MH, Chavez I, Gordon P, Abbott JD, Cagin C, Baudhuin L, Fu YP, Goodman SG, Hasan A, Iturriaga E, Lerman A, Sidhu M, Tanguay JF, Wang L, Weinshilboum R, Welsh R, Rosenberg Y, Bailey K, Rihal C. Effect of Genotype-Guided Oral P2Y12 Inhibitor Selection vs Conventional Clopidogrel Therapy on Ischemic Outcomes After Percutaneous Coronary Intervention: The TAILOR-PCI Randomized Clinical Trial. JAMA. 2020 Aug 25;324(8):761-771. doi: 10.1001/jama.2020.12443. |
| 37961335 | Background | Chanfreau-Coffinier C, Friede KA, Plomondon ME, Lee KM, Lu Z, Lynch JA, DuVall SL, Vassy JL, Waldo SW, Cleator JH, Maddox TM, Rader DJ, Assimes TL, Damrauer SM, Tsao PS, Chang KM, Voora D, Giri J, Tuteja S. CYP2C19 Polymorphisms and Clinical Outcomes Following Percutaneous Coronary Intervention (PCI) in the Million Veterans Program. medRxiv [Preprint]. 2023 Oct 26:2023.10.25.23297578. doi: 10.1101/2023.10.25.23297578. |
| 31316169 | Background | Martin J, Williams AK, Klein MD, Sriramoju VB, Madan S, Rossi JS, Clarke M, Cicci JD, Cavallari LH, Weck KE, Stouffer GA, Lee CR. Frequency and clinical outcomes of CYP2C19 genotype-guided escalation and de-escalation of antiplatelet therapy in a real-world clinical setting. Genet Med. 2020 Jan;22(1):160-169. doi: 10.1038/s41436-019-0611-1. Epub 2019 Jul 18. |
| 31202949 | Background | Sibbing D, Aradi D, Alexopoulos D, Ten Berg J, Bhatt DL, Bonello L, Collet JP, Cuisset T, Franchi F, Gross L, Gurbel P, Jeong YH, Mehran R, Moliterno DJ, Neumann FJ, Pereira NL, Price MJ, Sabatine MS, So DYF, Stone GW, Storey RF, Tantry U, Trenk D, Valgimigli M, Waksman R, Angiolillo DJ. Updated Expert Consensus Statement on Platelet Function and Genetic Testing for Guiding P2Y12 Receptor Inhibitor Treatment in Percutaneous Coronary Intervention. JACC Cardiovasc Interv. 2019 Aug 26;12(16):1521-1537. doi: 10.1016/j.jcin.2019.03.034. Epub 2019 Jun 12. |
| 35132875 | Background | Capodanno D, Angiolillo DJ, Lennon RJ, Goodman SG, Kim SW, O'Cochlain F, So DY, Sweeney J, Rihal CS, Farkouh M, Pereira NL. ABCD-GENE Score and Clinical Outcomes Following Percutaneous Coronary Intervention: Insights from the TAILOR-PCI Trial. J Am Heart Assoc. 2022 Feb 15;11(4):e024156. doi: 10.1161/JAHA.121.024156. Epub 2022 Feb 8. |
| 35402528 | Background | Al-Abcha A, Radwan Y, Blais D, Mazzaferri EL Jr, Boudoulas KD, Essa EM, Gumina RJ. Genotype-Guided Use of P2Y12 Inhibitors: A Review of Current State of the Art. Front Cardiovasc Med. 2022 Mar 23;9:850028. doi: 10.3389/fcvm.2022.850028. eCollection 2022. |
| 33763519 | Background | Dannenberg L, Afzal S, Czychy N, M'Pembele R, Zako S, Helten C, Mourikis P, Zikeli D, Ahlbrecht S, Trojovsky K, Benkhoff M, Barcik M, Wolff G, Zeus T, Kelm M, Polzin A. Risk prediction of bleeding and MACCE by PRECISE-DAPT score post-PCI. Int J Cardiol Heart Vasc. 2021 Mar 13;33:100750. doi: 10.1016/j.ijcha.2021.100750. eCollection 2021 Apr. |
| 27026020 | Background | Levine GN, Bates ER, Bittl JA, Brindis RG, Fihn SD, Fleisher LA, Granger CB, Lange RA, Mack MJ, Mauri L, Mehran R, Mukherjee D, Newby LK, O'Gara PT, Sabatine MS, Smith PK, Smith SC Jr. 2016 ACC/AHA Guideline Focused Update on Duration of Dual Antiplatelet Therapy in Patients With Coronary Artery Disease: A Report of the American College of Cardiology/American Heart Association Task Force on Clinical Practice Guidelines: An Update of the 2011 ACCF/AHA/SCAI Guideline for Percutaneous Coronary Intervention, 2011 ACCF/AHA Guideline for Coronary Artery Bypass Graft Surgery, 2012 ACC/AHA/ACP/AATS/PCNA/SCAI/STS Guideline for the Diagnosis and Management of Patients With Stable Ischemic Heart Disease, 2013 ACCF/AHA Guideline for the Management of ST-Elevation Myocardial Infarction, 2014 AHA/ACC Guideline for the Management of Patients With Non-ST-Elevation Acute Coronary Syndromes, and 2014 ACC/AHA Guideline on Perioperative Cardiovascular Evaluation and Management of Patients Undergoing Noncardiac Surgery. Circulation. 2016 Sep 6;134(10):e123-55. doi: 10.1161/CIR.0000000000000404. Epub 2016 Mar 29. No abstract available. |
| 28886622 | Background | Valgimigli M, Bueno H, Byrne RA, Collet JP, Costa F, Jeppsson A, Juni P, Kastrati A, Kolh P, Mauri L, Montalescot G, Neumann FJ, Petricevic M, Roffi M, Steg PG, Windecker S, Zamorano JL, Levine GN; ESC Scientific Document Group; ESC Committee for Practice Guidelines (CPG); ESC National Cardiac Societies. 2017 ESC focused update on dual antiplatelet therapy in coronary artery disease developed in collaboration with EACTS: The Task Force for dual antiplatelet therapy in coronary artery disease of the European Society of Cardiology (ESC) and of the European Association for Cardio-Thoracic Surgery (EACTS). Eur Heart J. 2018 Jan 14;39(3):213-260. doi: 10.1093/eurheartj/ehx419. No abstract available. |
| 37632363 | Background | Luengo-Fernandez R, Walli-Attaei M, Gray A, Torbica A, Maggioni AP, Huculeci R, Bairami F, Aboyans V, Timmis AD, Vardas P, Leal J. Economic burden of cardiovascular diseases in the European Union: a population-based cost study. Eur Heart J. 2023 Dec 1;44(45):4752-4767. doi: 10.1093/eurheartj/ehad583. |
| 28923905 | Background | Crea F, Libby P. Acute Coronary Syndromes: The Way Forward From Mechanisms to Precision Treatment. Circulation. 2017 Sep 19;136(12):1155-1166. doi: 10.1161/CIRCULATIONAHA.117.029870. |
| CPIC® Guideline for Clopidogrel and CYP2C19 | View source |
| PharmGKB Clinical Annotations of Clopidogrel, information about variant-drug pairs based primarily on variant annotations and incorporating variant-specific prescribing guidance from clinical guidelines and FDA-approved drug labels, when available. | View source |
| Dean L, Kane M. Clopidogrel Therapy and CYP2C19 Genotype. 2012 Mar 8 \[Updated 2022 Dec 1\]. In: Pratt VM, Scott SA, Pirmohamed M, et al., editors. Medical Genetics Summaries \[Internet\]. Bethesda (MD): National Center for Biotechnology Information (US); 20 | View source |
43 study participants diagnosed with chronic coronary artery disease who had undergone elective PCI, tested with CYP2C19 genotyping, identified as LoF *2, *3 alleles carriers. |
| FG002 | Unspecified Metabolizers of Clopidogrel | 83 participants diagnosed with chronic coronary artery disease who had undergone elective PCI were allocated to the arm through the randomization, without CYP2C19 genotyping and clopidogrel metabolism phenotype have not been specified. |
| COMPLETED |
|
| NOT COMPLETED |
|
|
Study participants of both sexes aged 35-79 years old, diagnosed with chronic coronary artery disease who had undergone elective PCI and required P2Y12 inhibitor antiplatelet treatment
Not provided
| ID | Title | Description |
|---|---|---|
| BG000 | Normal Metabolizers of Clopidogrel | 157 study participants diagnosed with chronic coronary artery disease who had undergone elective PCI, tested with CYP2C19 genotyping and identified as NFA *2, *3 carriers. |
| BG001 | Passive Metabolizers of Clopidogrel | 43 study participants diagnosed with chronic coronary artery disease who had undergone elective PCI, tested with CYP2C19 genotyping, identified as LoF *2, *3 alleles carriers. |
| BG002 | Unspecified Metabolizers of Clopidogrel | 83 participants diagnosed with chronic coronary artery disease who had undergone elective PCI were allocated to the arm through the randomization, without CYP2C19 genotyping and clopidogrel metabolism phenotype have not been specified. |
| BG003 | Total | Total of all reporting groups |
| Units | Counts |
|---|---|
| Participants |
|
| Title | Description | Population Description | Parameter Type | Dispersion Type | Unit of Measure | Calculate Percentage | Denominator Units Selected | Denominators | Classes | |||||
|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|
| Age, Continuous | The mean age of study arm participants is given for overall and sex-specific groups | Mean | Standard Deviation | years |
| |||||||||
| Age, Customized | Count of Participants | Participants |
| |||||||||||
| Sex: Female, Male | Count of Participants | Participants |
| |||||||||||
| Race (NIH/OMB) | Count of Participants | Participants |
| |||||||||||
| Region of Enrollment | Count of Participants | Participants |
| |||||||||||
| Smoking status of study participants | Smoking status measured as number and percentage of Current Smokers, Former Smokers and Never Smokers among study participants | Smoking status patterns among overall, sex-specific and age-specific study participants groups | Count of Participants | Participants |
| |||||||||
| Obesity among study participants | Number and percentage of study participants with obesity (BMI =>30kg/m^2 but <=40kg/m^2) | Number and percentage of obese study participants in the overall, sex- and age-specific groups | Count of Participants | Participants |
| |||||||||
| Body Mass Index (BMI) of study participants | Body Mass Index (BMI) of study participants measured as Body Weight/Body Height^2 (kg/m^2) | The mean BMI (kg/m^2) of overall, sex- and age-specific group study participants | Mean | Standard Deviation | kg/m^2 |
| ||||||||
| Blood Pressure control | Blood pressure (BP) controlling status assessed as controlled (SBP<140mmHg and DBP<90mmHg) or uncontrolled (SBP>/=140mmHg and/or DBP>/=90mmHg) at the time of study enrollment | Number and percentage of study participants with controlled and uncontrolled blood pressure in the overall, and sex- and age-specific groups | Count of Participants | Participants |
| |||||||||
| BP measurement results of study participants | SBP and DBP measurement results (mmHg) of study participants at the time of study enrollment | The mean SBP and DBP (mmHg) of study participants overall, and by sex- and age-specific groups | Mean | Standard Deviation | mmHg |
| ||||||||
| Type 2 Diabetes Mellitus | Type 2 Diabetes Mellitus (T2DM) control status of study participant measured as Uncontrolled (diagnosed T2DM and glycated hemoglobin (HbA1c) is >/=6.2%), Controlled (diagnosed T2DM and HbA1c is <6.2%) and No T2DM (not diagnosed T2DM and HbA1c is <6.2%) | Number and percentage of study participants with Uncontrolled, Controlled and No T2DM in overall, by sex- and age-specific arms at the time of enrollment | Count of Participants | Participants |
| |||||||||
| Glycated Hemoglobin (HbA1c) Levels | HbA1c (%) measurement results of study participants | Mean HbA1c measurement results (in %) of study participants overall, and by sex- and age-specific groups | Mean | Standard Deviation | percentage (%) of glycated hemoglobin |
| ||||||||
| Low Density Lipoprotein Cholesterol (LDL-C) Controlling Status | Serum Low Density Lipoprotein Cholesterol (LDL) control status measured as Controlled (LDL-C <55mg/dl ) or Uncontrolled (LDL-C >/=55mg/dl) | Number and percentage of study participants with uncontrolled and controlled LDL-C levels in the overall, and by sex- and age-specific groups | Count of Participants | Participants |
| |||||||||
| Serum LDL-C measurement results | The mean serum LDL-C measurement results (in mg/dl) of study participants at the time of enrollment | The mean LDL-C level of study participants overall, and by sex- and age-specific groups | Mean | Standard Deviation | mg/dl |
| ||||||||
| Symptom manifestations/conditions prior to index PCI | Any cardiovascular disease/condition present in the past medical history | Number and percentage of study participants with angina and other clinical conditions considered as the reason for the most recent PCI | Count of Participants | Participants |
| |||||||||
| History of Cardiovascular Morbidity | The number and percentage (%) of study participants with any cardiovascular disease/condition presented in the past medical history | Count of Participants | Participants |
| ||||||||||
| Coronary artery bypass grafting | The number and percentage of study participants undergone coronary artery bypass grafting (CABG) in the past medical history | Count of Participants | Participants |
| ||||||||||
| Major Coronary Vascular Event | The mean number of non-fatal major coronary vascular event assessed as prior myocardium infarction and PCIs underwent in the past medical history | Mean | Standard Deviation | number of events |
| |||||||||
| Atherosclerotic vascular co-morbid diseases/conditions | Number and percentage of study participants priorly diagnosed atherosclerotic vascular co-morbid diseases/conditions in the past medical history | Count of Participants | Participants |
| ||||||||||
| Other co-morbid diseases/conditions | Number and percentage of study participants priorly diagnosed with other co-morbid diseases/conditions in the past medical history | Count of Participants | Participants |
| ||||||||||
| Coronary Artery Lesion | The mean number of any and haemodynamically significant (>50% stenosis in the left main - LM, or ≥70% stenosis in the left anterior descending - LAD, the left circumflex - LCX, and the right coronary - RCA) lesion sites of coronary arteries | Mean | Standard Deviation | Coronary artery lesions |
| |||||||||
| Intracoronary Stenting History | The number of intracoronary stents ever placed | Mean | Standard Deviation | number of stents |
| |||||||||
| Coronary Artery Anatomy | Number and percentage of study participants with obstructive or non-obstructive lesions of the certain coronary arteries assessed by coronary angiography at the time of index PCI | Count of Participants | Participants |
| ||||||||||
| Echocardiographic Linear Dimensions | Mean linear dimension values of cardiac structural elements measured by echocardiographic imaging | Mean | Standard Deviation | millimeter |
| |||||||||
| Left Ventricular Volume Index | Left ventricular end-diastolic volume in millilitres measured by the biplane area-length method using 4- and 2-chamber views with two-dimensional echocardiographic imaging and indexed with the patient's body surface area in square meters calculated by the Du Bois formula | Mean | Standard Deviation | milliliter per square meter (ml/m^2) |
| |||||||||
| Left Atrium Volume Index | Left atrium end-systolic volume in millilitres measured by biplane area-length method using 4- and 2-chamber views with two-dimensional echocardiographic assessment and indexed with the patient's body surface area in square meters calculated by the Du Bois formula | Mean | Standard Deviation | millilitre per square meter (ml/m^2) |
| |||||||||
| Left Ventricular Mass Index | Left ventricular myocardium mass in grams calculated by Deverioux regression model formula using linear sizes of left ventricular posterior wall thickness, interventricular septum thickness and end-diastolic cavity diameter in centimeters with retraction of left ventricular cavity volume from volume enclosed by epicardium to obtain the net myocardium volume in millilitres, than multiplicated by the myocardium density measured in grams per millilitre and indexed with the patient's body surface area in square meters calculated by the Du Bois formula | Mean | Standard Deviation | gram per square meter (g/m^2) |
| |||||||||
| Left Ventricular Relative Wall Thickness | Left ventricular relative wall thickness is measured as the ratio of the sum of the linear dimensions of the posterior wall and interventricular wall thicknesses in millimetres divided by the end-diastolic diameter of the left ventricular cavity in millimetres | Mean | Standard Deviation | proportion in hundredths |
| |||||||||
| Left Ventricular Ejection Fraction | The portion of blood volume ejected during the systole (stroke volume) in percent measured as the difference of end-diastolic and end-systolic volumes of left ventricle divided by end-diastolic volume of left ventricle using equations for biplane area-length method for two-dimensional echocardiographic measurements of left ventricular volume from 4- and 2-chamber imaging. | Mean | Standard Deviation | portion of volume in percent (%) |
| |||||||||
| Tricuspid Annular Plane Systolic Excursion | Tricuspid annular plane systolic excursion assessed by M-mode echocardiography imaging in 4- and 2-chamber view by measuring the linear dimension of the displacement of the tricuspid annulus in millimetres relative to the right ventricular apex | Mean | Standard Deviation | millimeters |
| |||||||||
| Pulmonary Artery Systolic Pressure | Pulmonary artery systolic pressure in millimetres of mercury (mmHg), estimated by Doppler-, echocardiography in the absence of right ventricular outflow tract obstruction or pulmonary stenosis, based on tricuspid regurgitant jet velocity using the modified Bernoulli equation and right atrial pressure measured by inferior vena cava diameter and collapsibility | Mean | Standard Deviation | millimetres of mercury (mmHg) |
| |||||||||
| Doppler- echocardiographic characteristics | Number and percentage of study participants with specific qualitative doppler-echocardiographic characteristics of heart structure and function | Count of Participants | Participants |
|
| Type | Title | Description | Population Description | Reporting Status | Anticipated Posting Date | Parameter Type | Dispersion Type | Unit of Measure | Calculate Percentage | Time Frame | Units Analyzed | Denominator Units Selected | Arm/Group Information | Denominators | Classes | Analyses | ||||||||||||||||||||||||||
|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|
| Primary | Number of Study Participants Who Died From Any Cause (Death From Any Cause) | The event of death from any cause reported by the physician according to the WHO Clinical criteria for the determination of death or the incident declared by the caregiver of the patient and checked for appropriateness in hospital registries or the national death registry within the study follow-up period, from the date of study enrollment until the date of the event. | Study participants of both sexes aged 35-79 years old, diagnosed with chronic coronary artery disease, who had undergone elective PCI and required P2Y12 inhibitor antiplatelet treatment | Posted | Count of Participants | Participants | within a 12-month of the study follow-up |
|
|
| ||||||||||||||||||||||||||||||||
| Primary | Number of Study Participants Who Died From Any Cardiovascular Cause (Death From Cardiovascular Cause) | The event of death from any cardiovascular cause reported by the physician according the SCTI (Standardized Data Collection for Cardiovascular Trials Initiative) definitions or the incident declared by the caregiver of the patient and checked for appropriateness in hospital registries or the national death registry within the study follow-up period, from the date of study enrollment until the date of the event. | Study participants of both sexes aged 35-79 years old, diagnosed with chronic coronary artery disease, who had undergone elective PCI and required P2Y12 inhibitor antiplatelet treatment | Posted | Count of Participants | Participants | within a 12-month of the study follow-up |
| ||||||||||||||||||||||||||||||||||
| Primary | Number of Study Participants Who Died From Non-cardiovascular Causes (Death From Non-cardiovascular Cause) | The event of death from a non-cardiovascular cause reported by the physician or the incident declared by the caregiver of the patient and checked for appropriateness in hospital registries or the national death registry within the study follow-up period, from the date of study enrollment until the date of the event. | Study participants of both sexes aged 35-79 years old, diagnosed with chronic coronary artery disease, who had undergone elective PCI and required P2Y12 inhibitor antiplatelet treatment | Posted | Count of Participants | Participants | within a 12-month of the study follow-up |
| ||||||||||||||||||||||||||||||||||
| Secondary | Number of Study Participants Who Experienced Non-fatal Myocardial Infarction (Non-fatal Myocardial Infarction) | The clinical event of the non-fatal myocardial infarction detected during the study follow-up period and assessed by the 2012 Third Universal Definition of Myocardial Infarction as recommended by the SCTI (Standardized Data Collection for Cardiovascular Trials Initiative) definitions during the study follow-up period, from the date of study enrollment until the date of the event. | Study participants of both sexes aged 35-79 years old, diagnosed with chronic coronary artery disease, who had undergone elective PCI and required P2Y12 inhibitor antiplatelet treatment | Posted | Count of Participants | Participants | within a 12-month of the study follow-up |
| ||||||||||||||||||||||||||||||||||
| Secondary | Number of Study Participants Who Experienced Unstable Angina or Angina Requiring Hospitalization (Unstable Angina) | The clinical event corresponding to the unstable angina, or angina that requires hospitalization detected during the study follow-up period and assessed by the SCTI (Standardized Data Collection for Cardiovascular Trials Initiative) definitions during the study follow-up period, from the date of study enrollment until the date of the event. | Study participants of both sexes aged 35-79 years old, diagnosed with chronic coronary artery disease, who had undergone elective PCI and required P2Y12 inhibitor antiplatelet treatment | Posted | Count of Participants | Participants | within a 12-month of the study follow-up |
| ||||||||||||||||||||||||||||||||||
| Secondary | Number of Study Participants Who Experienced a Stroke or Transitory Cerebral Ischemic Event Within the Study Follow-up Period (Stroke or TIA) | The clinical event of the stroke or transitory ischemic attack detected during the study follow-up period and assessed by the SCTI (Standardized Data Collection for Cardiovascular Trials Initiative) definitions for Stroke and Transient Ischemic Attack during the study follow-up period, from the date of study enrollment until the date of the event. | Study participants of both sexes aged 35-79 years old, diagnosed with chronic coronary artery disease, who had undergone elective PCI and required P2Y12 inhibitor antiplatelet treatment | Posted | Count of Participants | Participants | within a 12-month of the study follow-up |
| ||||||||||||||||||||||||||||||||||
| Secondary | Number of Study Participants Who Experienced Major Bleeding (Major Bleeding) | The clinical event of major bleeding detected during the study follow-up period and assessed by the ARC-HBR (Academic Research Consortium for High Bleeding Risk) definitions as BARC type 3, 5 of bleeding during the study follow-up period, from the date of study enrollment until the date of the event. | Study participants of both sexes aged 35-79 years old, diagnosed with chronic coronary artery disease, who had undergone elective PCI and required P2Y12 inhibitor antiplatelet treatment | Posted | Count of Participants | Participants | within a 12-month of the study follow-up |
| ||||||||||||||||||||||||||||||||||
| Secondary | Number of Study Participants Who Experienced Non-major Bleeding (Non-major Bleeding) | The clinical event of major bleeding detected during the study follow-up period and assessed by the ARC-HBR (Academic Research Consortium for High Bleeding Risk) definitions as BARC type 1 of bleeding during the study follow-up period, from the date of study enrollment until the date of the event. | Study participants of both sexes aged 35-79 years old, diagnosed with chronic coronary artery disease, who had undergone elective PCI and required P2Y12 inhibitor antiplatelet treatment | Posted | Count of Participants | Participants | within a 12-month of the study follow-up |
| ||||||||||||||||||||||||||||||||||
| Secondary | Number of Study Participants Who Experienced Heart Failure Event (Heart Failure Event) | The clinical event of heart failure that requires hospitalization detected during the study follow-up period and assessed by the SCTI (Standardized Data Collection for Cardiovascular Trials Initiative) definitions during the study follow-up period, from the date of study enrollment until the date of the event. | Study participants of both sexes aged 35-79 years old, diagnosed with chronic coronary artery disease, who had undergone elective PCI and required P2Y12 inhibitor antiplatelet treatment | Posted | Count of Participants | Participants | within a 12-month of the study follow-up |
| ||||||||||||||||||||||||||||||||||
| Secondary | Number of Study Participants Who Experienced Percutaneous Coronary Intervention or Coronary Artery Bypass-grafting (Repeated Coronary Revascularization) | The clinical event of any repeated coronary revascularization: percutaneous coronary intervention or coronary artery bypass-grafting detected during the study follow-up period and assessed by the SCTI (Standardized Data Collection for Cardiovascular Trials Initiative) definitions during the study follow-up period, from the date of study enrollment until the date of the event. | Study participants of both sexes aged 35-79 years old, diagnosed with chronic coronary artery disease, who had undergone elective PCI and required P2Y12 inhibitor antiplatelet treatment | Posted | Count of Participants | Participants | within a 12-month of the study follow-up |
| ||||||||||||||||||||||||||||||||||
| Other Pre-specified | Number of Study Cases in Each Arm With a Composite of Death From Any Cause, Non-fatal Myocardial Infarction, Stroke/TIA, or Major Bleeding Within the Study Follow-up (Net Adverse Clinical Events - NACEs) | Net adverse clinical event (NACE) is assessed via measuring and putting together death from any cause, non-fatal myocardial infarction, stroke/TIA, or major bleeding (BARC type 3, 5) as potential outcomes for every studied case during the study follow-up period, from the date of study enrollment until the date of the event. | Study participants of both sexes aged 35-79 years old, diagnosed with chronic coronary artery disease, who had undergone elective PCI and required P2Y12 inhibitor antiplatelet treatment | Posted | Count of Participants | Participants | within a 12-month of the study follow-up |
| ||||||||||||||||||||||||||||||||||
| Other Pre-specified | Number of Study Cases in Each Study Arm With a Composite of Death From Any Cause, Myocardial Infarction, or Stroke/TIA Within the Study Follow-up (Major Adverse Cardiac or Cerebral Events - MACCEs) | Major adverse cardiac or cerebral event (MACCE) is assessed by measuring and putting together death from cardiovascular cause, non-fatal myocardial infarction, or stroke/TIA as potential outcomes for every studied case during the study follow-up period, from the date of study enrollment until the date of the event. | Study participants of both sexes aged 35-79 years old, diagnosed with chronic coronary artery disease, who had undergone elective PCI and required P2Y12 inhibitor antiplatelet treatment | Posted | Count of Participants | Participants | within a 12-month of the study follow-up |
| ||||||||||||||||||||||||||||||||||
| Other Pre-specified | Number of Study Cases With Certain Antiplatelet Treatment Selection (Dual Antiplatelet Treatment, Triple Antiplatelet Treatment, Combined Antiplatelet and Anticoagulant, or Antiplatelet Monotherapy) in Each Study Arm | The number and percentage (%) of each arm of study participants treated with dual antiplatelet treatment, triple antiplatelet treatment, antiplatelet and non-vitamin K antagonist oral anticoagulant combination, or antiplatelet monotherapy | Study participants of both sexes aged 35-79 years old, diagnosed with chronic coronary artery disease, who had undergone elective PCI and required P2Y12 inhibitor antiplatelet treatment | Posted | Count of Participants | Participants | within a 12-month of the study follow-up |
| ||||||||||||||||||||||||||||||||||
| Other Pre-specified | The Number of Study Cases With Certain Antiplatelet Medication (Aspirin, Clopidogrel, P2Y12 Inhibitor, Alternative to Clopidogrel, or A Non-vitamin K Antagonist Oral Anticoagulant (NOAC)) Prescription | The number and percentage (%) of study participants treated with a certain antiplatelet drug - aspirin, clopidogrel, P2Y12 inhibitor alternative to clopidogrel, or a non-vitamin K antagonist oral anticoagulant (NOAC) in each study arm | Study participants of both sexes aged 35-79 years old, diagnosed with chronic coronary artery disease, who had undergone elective PCI and required P2Y12 inhibitor antiplatelet treatment | Posted | Count of Participants | Participants | within a 12-month of the study follow-up |
| ||||||||||||||||||||||||||||||||||
| Other Pre-specified | The Number of Study Cases With Lipid-lowering Medication (Statin, or Combination With Ezetimibe, or Ezetimibe and PCSK9i) Prescription | The number and percentage (%) of study participants treated with lipid-lowering medication - statin, or combined statin and ezetimibe, or statin, ezetimibe and PCSK9i in each study arm | Study participants of both sexes aged 35-79 years old, diagnosed with chronic coronary artery disease, who had undergone elective PCI and required P2Y12 inhibitor antiplatelet treatment | Posted | Count of Participants | Participants | within a 12-month of the study follow-up |
| ||||||||||||||||||||||||||||||||||
| Other Pre-specified | The Number of Study Cases With Hypoglycemic Medication Prescription | The number and percentage (%) of study participants treated with certain hypoglycemic medication - insulin, sodium-glucose cotransporter-2 (SGLT2) inhibitor, metformin, glucagon-like peptide-1 (GLP-1) receptor agonist, or dipeptidyl peptidase IV (DPP IV) inhibitor in each study arm | Study participants of both sexes aged 35-79 years old, diagnosed with chronic coronary artery disease, who had undergone elective PCI and required P2Y12 inhibitor antiplatelet treatment | Posted | Count of Participants | Participants | within a 12-month of the study follow-up |
| ||||||||||||||||||||||||||||||||||
| Other Pre-specified | The Number of Study Cases With Other Common Evidence-Based Medication Prescription for Cardiovascular Risk Reduction | The number and percentage (%) of study participants treated with other common evidence-based medication for cardiovascular risk reduction - angiotensin converting enzyme inhibitor (ACEi), angiotensin receptor blocker (ARB), angiotensin receptor neprilysin inhibitor (ARNi), beta adrenergic blocker, loop diuretic, mineralocorticoid receptor antagonist (MCRA), thiazide diuretic, calcium channel blocker, anti-arrhythmic drug or ivabradine in each study arm | Study participants of both sexes aged 35-79 years old, diagnosed with chronic coronary artery disease, who had undergone elective PCI and required P2Y12 inhibitor antiplatelet treatment | Posted | Count of Participants | Participants | within a 12-month of the study follow-up |
| ||||||||||||||||||||||||||||||||||
| Other Pre-specified | Number of Study Participants Who Reported Their Health Status as Good or Satisfactory; or With the Appearance of CVD Symptoms; or With a Significant Inability to Self-care (Patient-Reported Health Status) | The health status reported by the patient as: a) good or satisfactory; b) with the appearance of CVD symptoms; c) a significant inability to self-care ranked with severity degree of patient well-being, symptom burden, or ability for self-care, which is assessed according to the routine health related quality of life questionnaire definitions. | Not Posted | at 3, 6 and 12-month of the study follow-up | Participants | |||||||||||||||||||||||||||||||||||||
| Other Pre-specified | Number of Study Participants Self-reported Angina Not Required Hospitalization (Patient-Reported Angina Not Required Hospitalization) | The participant-reported last week episode of chest pain, or any discomfort, shortness of breath, or tightness in the chest due to angina not required hospitalization assessed by the CROQ (Coronary Revascularization Outcome Questionnaire) definitions. | Not Posted | at 3, 6 and 12-month of the study follow-up | Participants | |||||||||||||||||||||||||||||||||||||
| Other Pre-specified | Number of Study Participants Reported Last Week's Shortness of Breath Due to Heart Failure Not Requiring Hospitalization (Patient-Reported Heart Failure Severity) | The participant reported last week's shortness of breath due to mild physical activity or at rest not requiring hospitalization assessed by the PROMIS®-Plus-HF (Patient-Reported Outcomes Measurement Information System®-Plus-Heart Failure) profile definitions. | Not Posted | at 3, 6 and 12 months of the study follow-up | Participants |
12-month period of the study follow-up
The data for adverse events were collected from the 250 participants who completed the study.
The study routinely collects information on Major Adverse Cardiovascular and Cerebrovascular Events (MACCEs) that are severe in terms of their outcome and considered as clinical endpoints of the study. They are presented in the study outcomes section as well.
Not provided
| ID | Title | Description | Deaths (Affected) | Deaths (At Risk) | Serious Events (Affected) | Serious Events (At Risk) | Other Events (Affected) | Other Events (At Risk) |
|---|---|---|---|---|---|---|---|---|
| EG000 | Normal Metabolizers of Clopidogrel | Study participants diagnosed with chronic coronary artery disease who had undergone elective PCI, tested with CYP2C19 genotyping and identified as NFA *2, *3 carriers. CYP2C19 Genotype-Guided Clopidogrel Treatment Clopidogrel as a component of preventive antiplatelet treatment, such as double antiplatelet treatment (DAPT), or an antiplatelet drug (clopidogrel) combined with the non-vitamin K antagonist oral anticoagulants (NOAC), incl. triple antiplatelet treatment (Aspirin, Clopidogrel and a NOAC), or antiplatelet monotherapy (Clopidogrel) | 8 | 142 | 23 | 142 | 4 | 142 |
| EG001 | Passive Metabolizers of Clopidogrel | Study participants diagnosed with chronic coronary artery disease who had undergone elective PCI, tested with CYP2C19 genotyping were identified as LoF *2, *3 allele carriers. CYP2C19 Genotype Guided Antiplatelet Treatment alternative to clopidogrel in conventional dosing regimen, as a component of preventive antiplatelet treatment, such as double antiplatelet treatment (DAPT) with ticagrelor or prasugrel, or prasugrel combined with the nonvitamin K antagonist oral anticoagulants (NOAC), or antiplatelet monotherapy (ticagrelor or prasugrel). | 2 | 38 | 10 | 38 | 4 | 38 |
| EG002 | Unspecified Metabolizers of Clopidogrel | Study participants diagnosed with chronic coronary artery disease who had undergone elective PCI were allocated to the arm through the randomisation, without CYP2C19 genotyping and clopidogrel metabolism phenotype has not been specified | 7 | 70 | 25 | 70 | 5 | 70 |
| Term | Organ System | Source Vocabulary | Assessment Type | Notes | Statistical Information |
|---|---|---|---|---|---|
| Major Bleeding | Blood and lymphatic system disorders | Non-systematic Assessment | A bleeding event, mostly GI, classified as Type 2 or 3 by the BARC (Bleeding Academic Research Consortium) scale |
| |
| Thrombocytopenia | Blood and lymphatic system disorders | Non-systematic Assessment | Decrease in platelet count <100×109/L or <50% compared to the previous measurement assessed by complete blood count |
| |
| Non-fatal Myocardial Infarction | Cardiac disorders | Non-systematic Assessment | The clinical event of the non-fatal myocardial infarction detected during the study follow-up period and assessed by the 2012 Third Universal Definition of Myocardial Infarction |
| |
| Unstable Angina or Angina Requiring Hospitalization | Cardiac disorders | Non-systematic Assessment | The clinical event corresponding to the unstable angina, or angina that required hospitalization, detected during the study follow-up period and assessed by the Standardized Data Collection for Cardiovascular Trials Initiative (SCTI) definitions |
| |
| Stroke or Transitory Cerebral Ischemic Event | Vascular disorders | Non-systematic Assessment | The clinical event of the stroke or transitory ischemic attack detected during the study follow-up period and assessed by theStandardized Data Collection for Cardiovascular Trials Initiative (SCTI) definitions |
| |
| Heart Failure Event | Cardiac disorders | Non-systematic Assessment | The clinical event of heart failure that requires hospitalization detected during the study follow-up period and assessed by the Standardized Data Collection for Cardiovascular Trials Initiative (SCTI) definitions |
|
| Term | Organ System | Source Vocabulary | Assessment Type | Notes | Statistical Information |
|---|---|---|---|---|---|
| Minor bleeding | Blood and lymphatic system disorders | Non-systematic Assessment | Any bleeding event classified as Type 1 by BARC (Bleeding Academic Research Consortium) scale, bleeding from gums, nosebleeds, or prolonged bleeding from cuts, did not seek unplanned medical attention |
| |
| Skin Rashes and Itching | Skin and subcutaneous tissue disorders | Non-systematic Assessment | Skin Rashes and Itching as the manifestation of hypersensitivity or allergy |
|
Not provided
Not provided
Not provided
| Title | Organization | Phone | Extension | |
|---|---|---|---|---|
| Konstantine Liluashvili , MD., PH.D. | Tbilisi State Medical University | +995599908899 | k.liluashvili@tsmu.edu |
| Jun 10, 2025 |
| Prot_SAP_000.pdf |
| ICF | No | No | Yes | Informed Consent Form | Jun 7, 2023 | Apr 18, 2025 | ICF_001.pdf |
| ID | Term |
|---|---|
| D003324 | Coronary Artery Disease |
| D003328 | Coronary Thrombosis |
| D002318 | Cardiovascular Diseases |
| D006470 | Hemorrhage |
| D003643 | Death |
| ID | Term |
|---|---|
| D003327 | Coronary Disease |
| D017202 | Myocardial Ischemia |
| D006331 | Heart Diseases |
| D001161 | Arteriosclerosis |
| D001157 | Arterial Occlusive Diseases |
| D014652 | Vascular Diseases |
| D013927 | Thrombosis |
| D016769 | Embolism and Thrombosis |
| D010335 | Pathologic Processes |
| D013568 | Pathological Conditions, Signs and Symptoms |
Not provided
Not provided
|
| mean age of female study participants |
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| mean age of male study participants |
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| Female study participants |
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| Male study participants |
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| 35-49 years old study participants |
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| 50-64 years old study participants |
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| 65-79 years old study participants |
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| Female study participants |
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| Male study participants |
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| 35-49 years study participants |
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| 50-64 years old study participants |
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| 65-79 years old study participants |
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| Female study participants |
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| Male study participants |
|
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| 35-49 years old study participants |
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| 50-64 years old study participants |
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| 65-79 years old study participants |
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| Female study participants |
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| Male study participants |
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| 35-49 years old study participants |
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| 50-64 years old study participants |
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| 65-79 years old study participants |
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| DBP of overall study participants |
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| SBP of female study participants |
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| DBP of female study participants |
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| SBP of male study participants |
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| DBP of male study participant |
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| SBP of 35-49 years old study participants |
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| DBP of 35-49 years old study participants |
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| SBP of 50-64 years old study participant |
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| DBP of 50-64 years old study participants |
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| SBP of 65-79 years old study participants |
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| DBP of 65-79 years old study participants |
|
|
|
| Female study participants |
|
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| Male study participants |
|
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| 35-49 years old study participants |
|
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| 40-64 years old study participants |
|
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| 65-79 years old study participants |
|
|
|
| Female study participants |
|
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| Male study participants |
|
|
| 35-49 years old study participants |
|
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| 50-64 years old study participants |
|
|
| 65-79 years old study participants |
|
|
|
| Female study participants |
|
|
| Male study participants |
|
|
| 35-49 years old study participants |
|
|
| 50-64 years old study participants |
|
|
| 65-79 years old study participants |
|
|
|
| Female study participants |
|
|
| Male study participants |
|
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| 35-49 years old study participants |
|
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| 50-64 years old study participants |
|
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| 65-79 years old study participants |
|
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| No angina |
|
|
| Heart Failure Event |
|
|
| Supraventricular Tachycardia |
|
|
| Atrial Fibrillation |
|
|
| Premature Ventricular Contraction/Ventricular tachycardia |
|
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| Left Bundle Branch Block |
|
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| Other non-specific symptoms |
|
|
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| Chronic Heart Failure |
|
|
| Supraventricular tachycardia - paroxysmal |
|
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| Supraventricular tachycardia - paroxysmal, recurrent |
|
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| Atrial Fibrillation - Paroxysmal |
|
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| Atrial Fibrillation - Persistent |
|
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| Atrial Fibrillation - Permanent |
|
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| Premature Ventricular Contraction |
|
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| Ventricular Tachycardia |
|
|
| Ventricular Fibrillation Event |
|
|
| Sinus Node Disfunction |
|
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| AV Block |
|
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| Left Bundle Branch Block |
|
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| Bight Bundle Branch Block |
|
|
|
|
| Number of PCIs |
|
|
|
| Peripheral Artery Disease with endarterectomy |
|
|
| Peripheral Artery Disease with stenting |
|
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| Peripheral Artery Disease with endarterectomy and stenting |
|
|
| Carotid Artery Disease without intravascular intervention |
|
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| Carotid Artery Disease with endarterectomy |
|
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| Carotid Artery Disease with stenting |
|
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| Carotid Artery Disease with endarterectomy and stenting |
|
|
| Cerebrovascular Disease with minor stroke |
|
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| Cerebrovascular Disease with TIA |
|
|
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| Chronic Kidney Disease |
|
|
| Peptic Ulcer |
|
|
| Chronic Gastritis |
|
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| GI Bleeding Event |
|
|
| Cured Cancer |
|
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| Thyroid Disease |
|
|
|
| Number of Haemodynamically Significant Coronary Artery Lesion Sites |
|
|
|
|
| Left main coronary artery : Non-obstructive |
|
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| Left anterior descending artery : Obstructive |
|
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| Left anterior descending artery : Non-obstructive |
|
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| 1st diagonal branch of the left anterior descending coronary artery : Obstructive |
|
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| 1st diagonal branch of the left anterior descending coronary artery : Non-obstructive |
|
|
| 2nd diagonal branch of the left anterior descending coronary artery : Obstructive |
|
|
| 2nd diagonal branch of the left anterior descending coronary artery : Non-obstructive |
|
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| Left circumflex artery : Obstructive |
|
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| Left circumflex artery : Non-obstructive |
|
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| 1st Marginal arteries : Obstructive |
|
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| 1st Marginal arteries : Non-obstructive |
|
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| 2nd Marginal arteries : Obstructive |
|
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| 2nd Marginal arteries : Non-obstructive |
|
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| Right coronary artery : Obstructive |
|
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| Right coronary artery : Non-obstructive |
|
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| Right marginal branch of right coronary artery : Obstructive |
|
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| Right marginal branch of right coronary artery : Non-obstructive |
|
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| Posterior descending artery : Obstructive |
|
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| Posterior descending artery : Non-obstructive |
|
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| Interventricular septum thickness |
|
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| Left ventricular end-diastolic diameter |
|
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| Left atrium transverse diameter |
|
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|
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|
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| Increased left ventricular filling pressure |
|
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| Right Ventricular Dilatation |
|
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| Mitral annular calcification (MAC) |
|
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| Secondary (functional) mitral regurgitation |
|
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| Aortic valve calcification |
|
|
| Secondary (functional) aortic regurgitation |
|
|
| Secondary (functional) tricuspid regurgitation |
|
|
| OG002 | Unspecified Metabolizers of Clopidogrel | Study participants diagnosed with chronic coronary artery disease who had undergone elective PCI were allocated to the arm through the randomisation, without CYP2C19 genotyping and clopidogrel metabolism phenotype was not specified |
|
|
| OG002 | Unspecified Metabolizers of Clopidogrel | Study participants diagnosed with chronic coronary artery disease who had undergone elective PCI were allocated to the arm through the randomisation, without CYP2C19 genotyping and clopidogrel metabolism phenotype was not specified |
|
|
| OG002 | Unspecified Metabolizers of Clopidogrel | Study participants diagnosed with chronic coronary artery disease who had undergone elective PCI were allocated to the arm through the randomisation, without CYP2C19 genotyping, and clopidogrel metabolism phenotype was not specified |
|
|
| OG002 | Unspecified Metabolizers of Clopidogrel | Study participants diagnosed with chronic coronary artery disease who had undergone elective PCI were allocated to the arm through the randomisation, without CYP2C19 genotyping, and clopidogrel metabolism phenotype was not specified |
|
|
| OG002 | Unspecified Metabolizers of Clopidogrel | Study participants diagnosed with chronic coronary artery disease who had undergone elective PCI were allocated to the arm through the randomisation, without CYP2C19 genotyping, and clopidogrel metabolism phenotype was not specified |
|
|
| OG002 | Unspecified Metabolizers of Clopidogrel | Study participants diagnosed with chronic coronary artery disease who had undergone elective PCI were allocated to the arm through the randomisation, without CYP2C19 genotyping, and clopidogrel metabolism phenotype was not specified |
|
|
| OG002 | Unspecified Metabolizers of Clopidogrel | Study participants diagnosed with chronic coronary artery disease who had undergone elective PCI were allocated to the arm through the randomisation, without CYP2C19 genotyping, and clopidogrel metabolism phenotype was not specified |
|
|
| OG002 | Unspecified Metabolizers of Clopidogrel | Study participants diagnosed with chronic coronary artery disease who had undergone elective PCI were allocated to the arm through the randomisation, without CYP2C19 genotyping, and clopidogrel metabolism phenotype was not specified |
|
|
Study participants diagnosed with chronic coronary artery disease who had undergone elective PCI, tested with CYP2C19 genotyping were identified as LoF *2, *3 allele carriers. CYP2C19 Genotype Guided Antiplatelet Treatment alternative to clopidogrel in conventional dosing regimen, as a component of preventive antiplatelet treatment, such as double antiplatelet treatment (DAPT) with ticagrelor or prasugrel, or prasugrel combined with the nonvitamin K antagonist oral anticoagulants (NOAC), or antiplatelet monotherapy (ticagrelor or prasugrel).
| OG002 | Unspecified Metabolizers of Clopidogrel | Study participants diagnosed with chronic coronary artery disease who had undergone elective PCI were allocated to the arm through the randomisation, without CYP2C19 genotyping, and clopidogrel metabolism phenotype was not specified |
|
|
Study participants diagnosed with chronic coronary artery disease who had undergone elective PCI, tested with CYP2C19 genotyping were identified as LoF *2, *3 allele carriers. CYP2C19 Genotype Guided Antiplatelet Treatment alternative to clopidogrel in conventional dosing regimen, as a component of preventive antiplatelet treatment, such as double antiplatelet treatment (DAPT) with ticagrelor or prasugrel, or prasugrel combined with the nonvitamin K antagonist oral anticoagulants (NOAC), or antiplatelet monotherapy (ticagrelor or prasugrel).
| OG002 | Unspecified Metabolizers of Clopidogrel | Study participants diagnosed with chronic coronary artery disease who had undergone elective PCI were allocated to the arm through the randomisation, without CYP2C19 genotyping, and clopidogrel metabolism phenotype was not specified |
|
|
Study participants diagnosed with chronic coronary artery disease who had undergone elective PCI, tested with CYP2C19 genotyping were identified as LoF *2, *3 allele carriers. CYP2C19 Genotype Guided Antiplatelet Treatment alternative to clopidogrel in conventional dosing regimen, as a component of preventive antiplatelet treatment, such as double antiplatelet treatment (DAPT) with ticagrelor or prasugrel, or prasugrel combined with the nonvitamin K antagonist oral anticoagulants (NOAC), or antiplatelet monotherapy (ticagrelor or prasugrel).
| OG002 | Unspecified Metabolizers of Clopidogrel | Study participants diagnosed with chronic coronary artery disease who had undergone elective PCI were allocated to the arm through the randomisation, without CYP2C19 genotyping, and clopidogrel metabolism phenotype was not specified |
|
|
| OG002 | Unspecified Metabolizers of Clopidogrel | Study participants diagnosed with chronic coronary artery disease who had undergone elective PCI were allocated to the arm through the randomisation, without CYP2C19 genotyping and clopidogrel metabolism phenotype was not specified |
|
|
| OG002 | Unspecified Metabolizers of Clopidogrel | Study participants diagnosed with chronic coronary artery disease who had undergone elective PCI were allocated to the arm through the randomisation, without CYP2C19 genotyping, and clopidogrel metabolism phenotype was not specified |
|
|
| OG002 | Unspecified Metabolizers of Clopidogrel | Study participants diagnosed with chronic coronary artery disease who had undergone elective PCI were allocated to the arm through the randomisation, without CYP2C19 genotyping, and clopidogrel metabolism phenotype was not specified |
|
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| OG002 | Unspecified Metabolizers of Clopidogrel | Study participants diagnosed with chronic coronary artery disease who had undergone elective PCI were allocated to the arm through the randomisation, without CYP2C19 genotyping, and clopidogrel metabolism phenotype was not specified |
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Study participants diagnosed with chronic coronary artery disease who had undergone elective PCI, tested with CYP2C19 genotyping were identified as LoF *2, *3 allele carriers. CYP2C19 Genotype Guided Antiplatelet Treatment alternative to clopidogrel in conventional dosing regimen, as a component of preventive antiplatelet treatment, such as double antiplatelet treatment (DAPT) with ticagrelor or prasugrel, or prasugrel combined with the nonvitamin K antagonist oral anticoagulants (NOAC), or antiplatelet monotherapy (ticagrelor or prasugrel). |
| OG002 | Unspecified Metabolizers of Clopidogrel | Study participants diagnosed with chronic coronary artery disease who had undergone elective PCI were allocated to the arm through the randomisation, without CYP2C19 genotyping, and clopidogrel metabolism phenotype was not specified |
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| Former Smoker |
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| Never Smoker |
|
| Former Smoker |
|
| Never Smoker |
|
| Former Smoker |
|
| Never Smoker |
|
| Former Smoker |
|
| Never Smoker |
|
| Former Smoker |
|
| Never Smoker |
|
| with Uncontrolled BP |
|
| with Uncontrolled BP |
|
| with Uncontrolled BP |
|
| with Uncontrolled BP |
|
| with Uncontrolled BP |
|
| Controlled T2DM |
|
| No T2DM |
|
| Controlled T2DM |
|
| No T2DM |
|
| Controlled T2DM |
|
| No T2DM |
|
| Controlled T2DM |
|
| No T2DM |
|
| Controlled T2DM |
|
| No T2DM |
|
| Controlled LDL-C Level |
|
| Controlled LDL-C Level |
|
| Controlled LDL-C Level |
|
| Controlled LDL-C Level |
|
| Controlled LDL-C Level |
|