Randomized, Double-Blind, Placebo-controlled Trial of 6 vs. 12 Months Clopidogrel Therapy After Implantation of a Drug-Eluting Stent
试验速览
- 阶段
- 4 期
- 发起方
- 入组人数
- 4,005
- 试验地点
- 40
- 主要终点
- Composite of death, myocardial infarction, stent thrombosis, stroke or TIMI major bleeding.
研究概览
简要总结
The purpose of this study is to determine whether a 6 month duration of clopidogrel therapy after DES implantation is not inferior to that of a 12 month therapy.
详细描述
Drug elution from stent struts is associated with less smooth muscle cell proliferation and delayed stent strut re-endothelialization. Thus it seems conceivable that a longer duration of dual antiplatelet therapy (aspirin and clopidogrel) after DES implantation is needed. However, no studies have been done to investigate which is the optimal antiplatelet therapy duration after DES implantation. Therefore, the objective of the randomized, double-blind, placebo-controlled ISAR-SAFE study is to evaluate the safety and efficacy of a 6 month versus a 12 month duration of clopidogrel therapy after DES implantation.
Patients on clopidogrel therapy at least 6 months after DES implantation, who do not require a reintervention will be randomized to an additional 6 month period of clopidogrel or placebo. The patients will be followed-up for 9 months after randomization.
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 on clopidogrel therapy at 6 months (-1/+2 months) after DES implantation
- •Informed, written consent by the patient
排除标准
- •Age ≤18 years
- •Clinically symptoms, proof of ischemia and/or presence of angiographic lesions requiring revascularization
- •Previous stent thrombosis
- •DES in left main coronary artery
- •ST-elevation and non-ST-elevation myocardial infarction during the last 6 months
- •Malignancies or other comorbid conditions with a life expectancy of less than one year or that may result in protocol noncompliance
- •Planned major surgery within the next 6 months with the need to discontinue antiplatelet therapy
- •Active bleeding; bleeding diathesis; history intracranial bleeding
- •Oral anticoagulation therapy with coumadin derivatives
- •Known allergy or intolerance to the study medications: aspirin and clopidogrel
- •Pregnancy (present, suspected or planned) or positive pregnancy test (In women with childbearing potential a negative pregnancy test is mandatory)
- •Patient's inability to fully comply with the study protocol
- •Prior enrollment in the same clinical trial.
研究组 & 干预措施
Clopidogrel
干预措施: Clopidogrel (Drug)
Placebo
干预措施: Placebo (Drug)
结局指标
主要结局
Composite of death, myocardial infarction, stent thrombosis, stroke or TIMI major bleeding.
时间窗: 9 months after randomization
次要结局
- The individual components of the primary endpoint(9 months after randomization)