Optimal Duration of Clopidogrel Therapy After Drug-Eluting Stent Implantation to Reduce Late Coronary Arterial Thrombotic Events
试验速览
- 阶段
- 4 期
- 状态
- 已完成
- 发起方
- 入组人数
- 5,000
- 试验地点
- 18
- 主要终点
- The composite of cardiac death, myocardial infarction, or stroke
研究概览
简要总结
This is randomized-controlled trial to evaluate the difference of composite of cardiac death, myocardial infarction, or Stroke between the dual antiplatelet therapy group and the aspirin monotherapy group after 1-year of drug-eluting stents implantation.
详细描述
This is subsequent clinical trial of previously published pooled analysis of the REAL-LATE and the ZEST-LATE Trial, in which nonsignificant higher trend for increased rate of death (all-cause and cardiac), myocardial infarction, or stroke in the dual antiplatelet therapy group compared to the aspirin monotherapy group was noted.
研究设计
- 研究类型
- Interventional
- 分配方式
- Randomized
- 干预模型
- Parallel
- 主要目的
- Treatment
- 盲法
- None
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
- •Patients had undergone DES implantation at least 12 months before enrollment, had not had a MACE (death, MI, stroke, or repeat revascularization) or major bleeding, and were dual-therapy at the time of enrollment.
- •Time for index PCI to randomization: 12-18 months
排除标准
- •Contraindications to the use of antiplatelet drugs (e.g., a concurrent bleeding diathesis or a history of major bleeding)
- •Concomitant vascular disease requiring long-term use of clopidogrel
- •Other established indications for clopidogrel therapy (e.g., a recent ACS).
- •Noncardiac coexisting conditions with a life expectancy < 1 year.
研究组 & 干预措施
Aspirin
Aspirin monotherapy (stopping clopidogrel at 1 year after DES)
干预措施: Aspirin monotherapy (Drug)
Aspirin,Clopidogrel
Aspirin,Clopidogrel Dual antiplatelet therapy (continue aspirin and clopidogrel 1year after DES)
干预措施: Aspirin,Clopidogrel (Drug)
结局指标
主要结局
The composite of cardiac death, myocardial infarction, or stroke
时间窗: at 2 year after randomization
次要结局
- stroke(at 2 year after randomization)
- death(at 2 year after randomization)
- myocardial infarction(at 2 year after randomization)
- stent thrombosis(at 2 year after randomization)
- Thrombolysis In Myocardial Infarction (TIMI) major/minor bleeding(at 2 year after randomization)
- Target Vessl revascularization(at 2 year after randomization)
- Target Lesion Revascularization(at 2 year after randomization)
研究者
Seung-Jung Park
MD,PhD, Chairman,Heart Institute, Asan Medical Center,University of Ulsan,College of Medicine
CardioVascular Research Foundation, Korea