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It is general that there are many factors for individual differences of drugs in clinical application, of which genetic factors accounted for more than 20%. Ticagrelor is a new-type receptor antagonist of P2Y12 and it is not affected by the influence of CYP2C19 polymorphism. With lack of predicted biomarkers, especially the research data of Chinese, it has the important significance in studying individual differences of ticagrelor in the antiplatelet efficacy and safety, through the pharmacogenomics research.
The aim of this study is to determine the polymorphism of drug metabolizing enzymes, drug transporters and drug target genes in Chinese population. By detecting the gene polymorphism, we intend to study the pharmacokinetic/ pharmacodynamics/ pharmacogenomics (PK-PD-PG) correlation of ticagrelor and provide scientific basis for accurate medication guide for people to use ticagrelor.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| wild genotype | Through next generation sequencing, distinguish wild genotype of ticagrelor |
| |
| mutant genotype | Through next generation sequencing, distinguish mutant genotype of ticagrelor |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| detection of genotype | Genetic | detection of genotype by next generation sequencing |
|
| Measure | Description | Time Frame |
|---|---|---|
| Incidence of major adverse cardiac events (MACE) | During the observation time, record the incidence of MACE after ticagrelor administration by telephone or outpatient clinic , including myocardial infarction, cardiac death, stent stenosis, stent thrombosis, ect. | At 1 year |
| Incidence of bleeding events | During the observation time, record the incidence of bleeding events after ticagrelor administration by telephone or outpatient clinic, including subcutaneous bleeding, gingival bleeding, gastrointestinal bleeding, intracranial hemorrhage, etc. | At 1 year |
| Measure | Description | Time Frame |
|---|---|---|
| genotype detected by next generation sequencing | Collect blood specimen before ticagrelor administration, then detect genotype of Ticagrelor by next generation sequencing. | pre-dose of Ticagrelor |
| Level of platelet reactivity assessed by ADP aggregation rate |
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Inclusion Criteria:
(I)Chinese Healthy Volunteers
(II)Chinese Patients
Exclusion Criteria:
(I)Chinese Healthy Volunteers
(II)Chinese Patients
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(I)Chinese Healthy Volunteers:In accordance with the criteria of each bioequivalence trial of ticagrelor;150-200 cases (II)Chinese Patients:With diagnosis of acute coronary syndrome (ACS),never received ticagrelor in a month and intend to take ticagrelor or have received ticagrelor for more than one week continuously;200 cases
| Name | Role | Phone | Extension | |
|---|---|---|---|---|
| Qian Xiang, Ph.D | Contact | +86 010 66110802 | xiangqz@126.com |
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| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| Anhui Provincial Hospital(The First Affiliated Hospital Of USTC) | Recruiting | Hefei | Anhui | 230001 | China |
| PubMed Identifier | Type | Citation | Retractions |
|---|---|---|---|
| 35501592 | Derived | Xiang Q, Liu Z, Mu G, Xie Q, Zhang H, Zhou S, Wang Z, Guo N, Huang J, Jiang J, Li J, Yang G, Cui Y. Effect of Genetic Polymorphism Including NUP153 and SVEP1 on the Pharmacokinetics and Pharmacodynamics of Ticagrelor in Healthy Chinese Subjects. Clin Drug Investig. 2022 May;42(5):447-458. doi: 10.1007/s40261-022-01154-6. Epub 2022 Apr 30. | |
| 35082514 |
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Before and after ticagrelor administration, record the ADP aggregation rate detected by Light Transmittance Aggregometry(LTA). |
| At baseline, at 12 hours for Chinese healthy volunteers or at 48 hours for Chinese patients. |
| Level of platelet reactivity assessed by PRI | Before and after ticagrelor administration, record PRI detected by VerifyNow System. | At baseline, at 12 hours for Chinese healthy volunteers or at 48 hours for Chinese patients. |
| Expression level of miRNA | Before and after ticagrelor administration, detect the expression level of miRNA about pharmacodynamics. | At baseline, at 12 hours for Chinese healthy volunteers or at 48 hours for Chinese patients. |
| Expression level of proteomics | Before and after ticagrelor administration, detect the expression level of proteomics about pharmacodynamics | At baseline, at 12 hours for Chinese healthy volunteers or at 48 hours for Chinese patients |
| Expression level of LncRNA | Before and after ticagrelor administration, detect the expression level of LncRNA about pharmacodynamics. | At baseline, at 12 hours for Chinese healthy volunteers;at 48 hours for Chinese patients. |
| Incidence of MACEs in the other observation times | During the other observation time, record the incidence of MACE after ticagrelor administration by telephone or outpatient clinic , including myocardial infarction, cardiac death, stent stenosis, stent thrombosis, ect. | At 1 month, 6 months and 2 years (according the actual duration of ticagrelor taken in patiens) |
| Incidence of bleeding events in the other observation times | During the other observation time, record the incidence of bleeding events after ticagrelor administration by telephone or outpatient clinic, including subcutaneous bleeding, gingival bleeding, gastrointestinal bleeding, intracranial hemorrhage, etc. | At 1 month, 6 months and 2 years (according the actual duration of ticagrelor taken in patiens) |
| The First Affiliated Hospital of Anhui Medical University | Recruiting | Hefei | Anhui | 230001 | China |
|
| Peking University First Hospital | Recruiting | Beijing | Beijing Municipality | 100034 | China |
|
| 900 Hospital of the Joint Logistics Team (Original name: Fuzhou General Hospital of Nanjing Militray Command) | Recruiting | Fuzhou | Fujian | China |
|
| The 7th People's Hospital Of Zhengzhou | Active, not recruiting | Zhengzhou | Henan | 450006 | China |
| The Third Xiangya Hospital of Central South University | Active, not recruiting | Changsha | Hunan | China |
| The Second Affiliated Hospital Of Nanchang University | Active, not recruiting | Nanchang | Jiangxi | 330006 | China |
| Yuan D, Shi X, Gao L, Wan G, Zhang H, Yang Y, Zhao Y, Sun D. Identification of Potential Biological Factors Affecting the Treatment of Ticagrelor After Percutaneous Coronary Intervention in the Chinese Population. Pharmgenomics Pers Med. 2022 Jan 20;15:29-43. doi: 10.2147/PGPM.S338287. eCollection 2022. |