NCT04989257尚未招募不适用
24-month Ticagrelor-based Dual-antiplatelet Therapy Versus Clopidogrel-based Dual-antiplatelet theRapy aftEr 12 Months of DrUg-eluting Stent Implantation in High isChEmic Risk Patients: P-REDUCE Trial
适应症
干预措施
相关药物
试验速览
- 阶段
- 不适用
- 状态
- 尚未招募
- 入组人数
- 3,488
- 试验地点
- 1
- 主要终点
- Composite of all-cause death, myocardial infarction, or stroke
研究概览
简要总结
The purpose of this prospective randomized clinical trial is to compare the clinical outcomes between aspirin with ticagrelor versus aspirin with clopidogrel in high ischemic risk patients beyond 12 months after percutaneous coronary intervention with 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
- None
入排标准
- 年龄范围
- 50 Years 至 85 Years（Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •Age ≥50 years old
- •History of drug-eluting stent implantation due to acute myocardial infarction 12 to 24 months ago
- •High-risk for ischemic events (at least one of the following) 1) Age >65 years old 2) Medical treatments for diabetes mellitus 3) Multi-vessel coronary artery disease 4) More than 2 episodes of myocardial infarction 5) Chronic kidney disease (stage III or IV)
排除标准
- •Age ≥85 years old
- •Pregnant women or women with potential childbearing
- •Life expectancy < 1 year
- •Inability to understand or read the informed consent
- •Need for long-term anticoagulation therapy
研究组 & 干预措施
Ticagrelor-based dual-antiplatelet therapy
Experimental
Aspirin with ticagrelor
干预措施: Ticagrelor-based dual-antiplatelet therapy (Drug)
Clopidogrel-based dual-antiplatelet therapy
Active Comparator
Aspirin with clopidogrel
干预措施: Clopidogrel-based dual-antiplatelet therapy (Drug)
结局指标
主要结局
Composite of all-cause death, myocardial infarction, or stroke
时间窗: up to 24 months
Composite of all-cause death, myocardial infarction, or stroke at 24 months after randomization
次要结局
- Stroke(up to 24 months)
- Composite of all-cause death, myocardial infarction, stroke, or BARC type 2, 3, or 5 bleeding(up to 24 months)
- Cardiac death(up to 24 months)
- BARC type 2, 3, or 5 bleeding(up to 24 months)
- All-cause death(up to 24 months)
- Myocardial infarction(up to 24 months)
研究者
研究点 (1)
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