Prospective, Randomized, Double-Blind Trial of Abrupt and Tapered Interruption of Long-term Clopidogrel Therapy After Implantation of a Drug-Eluting Stent
试验速览
- 阶段
- 4 期
- 状态
- 终止
- 发起方
- 入组人数
- 782
- 试验地点
- 2
- 主要终点
- Composite of cardiac death, myocardial infarction, stent thrombosis, stroke, major bleeding or rehospitalization due to acute coronary syndrome.
研究概览
简要总结
The hypothesis to be tested is that gradual clopidogrel therapy cessation is associated with a superior clinical outcome compared with abrupt cessation (superiority hypothesis).
详细描述
A possible rebound in platelet activity after clopidogrel withdrawal has been suggested in patients on chronic clopidogrel therapy. However, a systematic evaluation of the role of rapid thienopyridine withdrawal on ischemic complications in patients with treated coronary artery disease has not been addressed by specifically designed studies. The objective of this study is to evaluate the safety and efficacy of abrupt or tapered interruption of chronic clopidogrel therapy after intracoronary drug-eluting stent implantation.
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
- Quadruple (Participant, Care Provider, Investigator, Outcomes Assessor)
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 with planned interruption of chronic clopidogrel therapy after DES implantation
- •Informed, written consent by the patient
排除标准
- •Planned surgery within the next month
- •Active bleeding as reason for clopidogrel discontinuation
- •Concomitant coumadin therapy
- •Pregnancy (present, suspected or planned) or positive pregnancy test (In women with childbearing potential a negative pregnancy test is mandatory)
- •Malignancies or other comorbid conditions with a life expectancy of less than one year or that may result in protocol noncompliance.
- •Patient's inability to fully comply with the study protocol.
研究组 & 干预措施
Clopidogrel Tapering
干预措施: Clopidogrel Tapering (Drug)
Abrupt Clopidogrel Interruption
干预措施: Abrupt Clopidogrel Interruption (Drug)
结局指标
主要结局
Composite of cardiac death, myocardial infarction, stent thrombosis, stroke, major bleeding or rehospitalization due to acute coronary syndrome.
时间窗: 3 months after randomization
次要结局
- The individual components of the primary endpoint. All cause mortality.(3 months after randomization)