Associations of the Pharmacogenetic and Pharmacokinetic Factors With Clopidogrel Low Response and Clinical Outcome in Patients With Coronary Stent Implantation: a Registration Study
试验速览
- 阶段
- 不适用
- 状态
- 已完成
- 入组人数
- 1,805
- 试验地点
- 1
- 主要终点
- Risk ratio
研究概览
简要总结
This registration study aims to investigate the associations of the pharmacogenetic and pharmacokinetic factors with clopidogrel low response and clinical outcome in patients with coronary artery disease, and provide new pharmacogenetic and pharmacokinetic targets for the individualized anti-platelet treatment.
详细描述
Associations of the Pharmacogenetic and Pharmacokinetic Factors With Clopidogrel Low Response and Clinical Outcome in Patients With Coronary Stent Implantation: a Registration Study
Published data linking clopidogrel non-responsiveness to adverse ischaemic events lead to the suggestion that the magnitude of platelet inhibition by clopidogrel can be monitored and individually adjusted. This has been tested in randomised clinical trials (ARCTIC, GRAVITAS and TRIGGER-PCI), but despite reducing platelet reactivity, a strategy of therapy adjustment based on platelet function monitoring did not reduce the incidence of cardiac ischaemic events1, which indicates that most pharmacodynamical tests monitored anti-platelet treatment failed so far.
We accordingly performed this registration study to investigate whether the pharmacogenetic and pharmacokinetic factors are associated with clopidogrel low response as well as clinical outcome, and aimed to provide new targets for the individualized anti-platelet treatment.
Inclusion criteria:
- Successively recruit all patients who receive stent implantation and take aspirin 100 mg and clopidogrel 75 mg once daily (7:00 a.m.) for more than 5 days.
- Patient aged >18 years;
- Signed inform consent.
研究设计
- 研究类型
- Observational
- 观察模型
- Cohort
- 时间视角
- Prospective
入排标准
- 年龄范围
- 18 Years 至 —（Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •Successively recruit all patients who receive stent implantation and take aspirin 100 mg and clopidogrel 75 mg daily for more than 5 days.
- •Patient aged >18 years;
- •Signed inform consent.
排除标准
- •intolerant with aspirin or clopidogrel treatment (e.g. allergic reactions or gastrointestinal bleeding);
- •taking medication that could interfere with the antiplatelet efficacy of clopidogrel (e.g. vitamin K antagonists, direct oral anticoagulants or nonsteroidal anti-inflammatory drugs);
- •with myelodysplastic syndrome or abnormal baseline platelet counts of < 80 × 10∧9/L or > 450 × 10∧9/L;
- •hemoglobin < 90g/L;
- •with a history of cerebral hemorrhage within 1 year;
- •in pregnancy.
结局指标
主要结局
Risk ratio
时间窗: 1 year after patients' being recruited
Risk ratio of the pharmacokinetic results on MACE.
次要结局
- Risk ratio(1 month after patients' being recruited)
研究者
Chunjian Li
Professor
The First Affiliated Hospital with Nanjing Medical University