A Multi-centre, Open-labelled, Randomized Controlled Trial Comparing Two Different Anticoagulation Strategies in High-risk Atrial Fibrillation and Stable Coronary Artery Disease
试验速览
- 阶段
- 4 期
- 状态
- 已完成
- 发起方
- 入组人数
- 1,040
- 试验地点
- 18
- 主要终点
- Rate of net Clinical Outcome
研究概览
简要总结
This study evaluates the efficacy and safety of Edoxaban with the combination of edoxaban and antiplatelet in patients with stable CAD (coronary artery stenosis ≥50% on medical treatment or revascularized stable CAD [≥ 12 months for acute coronary syndrome and ≥ 6 months after stable CAD]) and high-risk atrial fibrillation (CHA2DS2-VASc score ≥2).
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
- 未提供
排除标准
- 未提供
研究组 & 干预措施
Edoxaban alone
干预措施: Edoxaban Monotherapy (Drug)
Combination of edoxaban plus single antiplatelet
干预措施: Edoxaban plus Single Antiplatelet Agent (Drug)
结局指标
主要结局
Rate of net Clinical Outcome
时间窗: 1 year
composites of death, stroke, systemic embolic event, myocardial infarction, unplanned revascularization of a major coronary artery, major bleeding, and clinically relevant non-major bleeding event
次要结局
- Rate of major bleeding(1 year)
- Rate of systemic embolism(1 year)
- Rate of unplanned revascularization(1 year)
- Rate of stent thrombosis(1 year)
- Rate of all cause death(1 year)
- Rate of cardiovascular death(1 year)
- Rate of composite of hard outcomes(1 year)
- Rate of intracranial hemorrhage(1 year)
- Rate of myocardial infarction(1 year)
- Rate of ischemic stroke(1 year)
- Rate of minor bleeding(1 year)
- Rate of composite of Major or clinically relevant non-major bleeding(1 year)
- Rate of fatal bleeding(1 year)
- Rate of gastrointestinal hemorrhage(1 year)
研究者
Gi-Byoung Nam
Professor, Asan Medical Center, University of Ulsan College of Medicine, Seoul, Korea
Asan Medical Center