Correlation of Clopidogrel Therapy Discontinuation in REAL-world Patients Treated With Drug-Eluting Stent Implantation and 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
- 2,000
- 试验地点
- 12
- 主要终点
- The composite of cardiac death or MI in the intent-to-treat population
研究概览
简要总结
The purpose of REAL-LATE (Correlation of Clopidogrel Therapy Discontinuation in REAL-world Patients Treated with Drug-Eluting Stent Implantation and Late Coronary Arterial Thrombotic Events) trial is to assess the relationship between clopidogrel use and long-term rates of cardiac death or MI after DES implantation in real-world practice and to estimate the duration of dual antiplatelet therapy for preventing the late thrombotic events.
详细描述
An observational analysis from BASKET-LATE (Basel Stent Kosten-Effekivitats Trial-Late Thrombotic Events) examined the incidence of clinical events after cessation of clopidogrel therapy. This study identified 746 patients who were without major adverse events 6 months after drug-eluting or bare-metal stent placement. All patients had stopped taking clopidogrel and were followed up for an additional 12 months. At 18-month follow-up, there was no difference between patients with a drug-eluting or bare-metal stent in cumulative rates of death or myocardial infarction (MI). However, after clopidogrel discontinuation patients receiving drug-eluting vs bare-metal stents experienced higher rates of death and MI (4.9% vs 1.3%, respectively). These results have created uncertainty regarding the minimal necessary duration of antiplatelet therapy after drug-eluting stent implantation. Also, there remains widespread uncertainty regarding the risk of clinical events after the discontinuation of clopidogrel, particularly after DES 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
- 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
- •Among consecutive patients treated with DES, event-free patients who survived at least the first 12 months without nonfatal MI or repeat revascularization
- •The patient or guardian agrees to the study protocol and the schedule of clinical follow-up, and provides informed, written consent, as approved by the appropriate Institutional Review Board/Ethical Committee of the respective clinical site.
排除标准
- •Contraindication to antiplatelet therapy (aspirin or clopidogrel)
- •Non-cardiac co-morbid conditions are present with life expectancy <1 year or that may result in protocol non-compliance (per site investigator's medical judgment).
- •Patients who are actively participating in another drug or device investigational study, which have not completed the primary endpoint follow-up period.
- •Concurrent bleeding diathesis or major bleeding history requiring discontinuation of antiplatelet drugs.
- •Patients with left main stem stenosis (>50% by visual estimate) or left main stenting
- •Concomitant disease requiring long-term use of clopidogrel (stroke, peripheral vascular disease, significant carotid a. disease, etc)
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 or MI in the intent-to-treat population
时间窗: 1 year after randomization
次要结局
- All death(1 year after randomization)
- Myocardial infarction(1 year after randomization)
- Stroke(1 year after randomization)
- Stent Thrombosis(1 year after randomization)
- Bleeding events(1 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