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The study aims to determine the feasibility and clinical utility of incorporating precision medicine approaches, incorporating both cytochrome P450 2C19 (CYP2C19) genotyping and platelet reactivity phenotyping, with standard of care for patients with acute coronary syndromes (ACS), post PCI.
Study Population:
Adult patients will be eligible for inclusion if they provide informed consent and have no contraindications for 12-months of dual antiplatelet therapy (DAPT).
Baseline Evaluation:
Overview of clinical protocol: Patients with successful PCI will receive a genotype guided recommendation, upon discharge, based on CYP2C19 genotype. Patients who are determined to have CYP2C19 poor metabolizer (PM) or intermediate metabolizer (IM) status will be recommended to receive 12-months of prasugrel. Patients who are determined to have CYP2C19 normal metabolizer (NM), rapid metabolizer (RM), or ultra-rapid metabolizer (UM) phenotype will be recommended to receive a de-escalation treatment, guided by on-treatment platelet reactivity phenotype at 14 days, post discharge.
30-day, 6-month, and 12-month Follow-up: Patients will be contacted by phone or visited during one of their regularly scheduled appointments, at 14 days, 30 days, 6 months , and 12 months, to complete "Follow-up Case Report Forms" to collect outcomes data. The 12-month follow up communication with enrolled patients will end their participation in the study.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| Precision medicine implementation | Other | Patients will receive a precision medicine approach, incorporating both CYP2C19 genotyping and platelet reactivity phenotyping, to guide dual antiplatelet therapy selection for patients with ACS, post PCI and followed over a 12 month period. |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| CYP2C19 genotyping | Genetic | Upon hospital discharge, patients will undergo CYP2C19 genotyping to guide initial P2Y12 inhibitor selection. At 14 days, post discharge, patients will undergo on treatment platelet reactivity phenotyping to further guide deescalation of P2Y12 inhibitor therapy |
| Measure | Description | Time Frame |
|---|---|---|
| Feasibility of implementing pharmacogenetics to guide antiplatelet therapy | The proportion of patients in whom a genetic-guided recommendation is accepted by the clinician | 12 months |
| Feasibility of implementing platelet reactivity testing to guide de-escalation of antiplatelet therapy | The proportion of patients in whom a platelet reactivity phenotype-guided recommendation is accepted by the clinician | 12 months |
| Measure | Description | Time Frame |
|---|---|---|
| Net clinical utility | The incidence of combined endpoints of major adverse cardiovascular events (MACE), stent thrombosis, unstable angina, major and minor bleeding, all-cause mortality, and hospital readmission rate within 30 days, post discharge | 30 days |
| Net clinical utility |
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Inclusion Criteria:
Exclusion Criteria:
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| Name | Affiliation | Role |
|---|---|---|
| Scott A Mosley, PharmD | University of Southern California School of Pharmacy | Principal Investigator |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| LAC+USC Medical Center | Los Angeles | California | 90033 | United States |
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Study protocol is anticipated to be published within 12 months of completing the study, and not anticipated to have a time limit.
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| ID | Term |
|---|---|
| D054058 | Acute Coronary Syndrome |
| D000072657 | ST Elevation Myocardial Infarction |
| D000072658 | Non-ST Elevated Myocardial Infarction |
| D000789 | Angina, Unstable |
| ID | Term |
|---|---|
| D017202 | Myocardial Ischemia |
| D006331 | Heart Diseases |
| D002318 | Cardiovascular Diseases |
| D014652 | Vascular Diseases |
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Prospective, single-center, single arm, pragmatic study to determine feasibility of intervention
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|
|
The incidence of combined endpoints of MACE, stent thrombosis, unstable angina, major and minor bleeding, all-cause mortality, and hospital readmission rate within 12 months, post discharge |
| 12 months |
| Change in score of anxiety using (Patient Reported Outcomes Measurement Information System (PROMIS) subscale) | Patient Reported Outcomes Measurement Information System (PROMIS) subscale for anxiety include fear, anxiety, worry, and uneasiness. A score of 0 to 20 based on survey responses will be resulted for this subscale, with higher values representing a worse outcome. | 30 days |
| Change in score of anxiety using (Patient Reported Outcomes Measurement Information System (PROMIS) subscale) | Patient Reported Outcomes Measurement Information System (PROMIS) subscale for anxiety include fear, anxiety, worry, and uneasiness. A score of 0 to 20 based on survey responses will be resulted for this subscale, with higher values representing a worse outcome. | 12 months |
| Change in score of depression using (Patient Reported Outcomes Measurement Information System (PROMIS) subscale) | Patient Reported Outcomes Measurement Information System (PROMIS) subscale for depression include worthless, helpless, depressed, and hopelessness. A score of 0 to 20 based on survey responses will be resulted for this subscale, with higher values representing a worse outcome. | 30 days |
| Change in score of depression using (Patient Reported Outcomes Measurement Information System (PROMIS) subscale) | Patient Reported Outcomes Measurement Information System (PROMIS) subscale for depression include worthless, helpless, depressed, and hopelessness. A score of 0 to 20 based on survey responses will be resulted for this subscale, with higher values representing a worse outcome. | 12 months |
| Change in score of social abilities using (Patient Reported Outcomes Measurement Information System (PROMIS) subscale) | Patient Reported Outcomes Measurement Information System (PROMIS) subscale for social abilities include leisure, family, usual work, and friends. A score of 0 to 20 based on survey responses will be resulted for this subscale, with higher values representing a worse outcome. | 30 days |
| Change in score of social abilities using (Patient Reported Outcomes Measurement Information System (PROMIS) subscale) | Patient Reported Outcomes Measurement Information System (PROMIS) subscale for social abilities include leisure, family, usual work, and friends. A score of 0 to 20 based on survey responses will be resulted for this subscale, with higher values representing a worse outcome. | 12 months |
| D009203 |
| Myocardial Infarction |
| D007238 | Infarction |
| D007511 | Ischemia |
| D010335 | Pathologic Processes |
| D013568 | Pathological Conditions, Signs and Symptoms |
| D009336 | Necrosis |
| D000787 | Angina Pectoris |
| D002637 | Chest Pain |
| D010146 | Pain |
| D009461 | Neurologic Manifestations |
| D012816 | Signs and Symptoms |