Twelve Versus 24 Months of Dual Antiplatelet Therapy in Patients With Percutaneous Coronary Intervention for In-stent Restenosis
试验速览
- 阶段
- 4 期
- 发起方
- 入组人数
- 1,000
- 试验地点
- 1
- 主要终点
- MACCE
研究概览
简要总结
Patients undergoing the percutaneous coronary intervention (PCI) for in-stent restenosis (ISR) are enrolled. All patients will be randomized to receive either 12 months or 24 months of dual antiplatelet therapy with a P2Y12 receptor antagonist in addition to aspirin, all patients continue receiving aspirin indefinitely. The primary efficacy end points of this study are the incidence of a composite end point including all cause deaths, myocardial infarction, the incidence of Academic Research Consortium defined definite or probable stent thrombosis and stroke (MACCE) at 24 months. The primary safety end point is the incidence of GUSTO moderate or severe bleeding.
详细描述
The ISR-DAPT Study is a multicenter, randomized controlled trial that will enroll 1000 subjects treated with percutaneous coronary intervention (PCI) for in-stent restenosis. All patients will be randomized to receive either 12 months or 24 months of dual antiplatelet therapy with a P2Y12 receptor antagonist in addition to aspirin after index procedure. All patients continue receiving aspirin indefinitely. The primary efficacy end points of this study are the incidence of a composite end point including all cause deaths, myocardial infarction, the incidence of Academic Research Consortium defined definite or probable stent thrombosis and stroke (MACCE) at 24 months. The primary safety end point is the incidence of GUSTO moderate or severe bleeding at 24 months.
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 80 Years（Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •Subjects 18-80 years of age
- •Undergoing percutaneous intervention with stent deployment for the treatment of in-stent restenosis
排除标准
- •Pregnant women
- •Planned surgery necessitating discontinuation of antiplatelet therapy within the 24 months after enrollment
- •Current medical condition with a life expectancy of <2 years
- •Concurrent enrollment in another device or drug study whose protocol specifically rules out concurrent enrollment
- •Subjects on warfarin or similar anticoagulant therapy
- •Subjects with hypersensitivity or allergies to one of the drugs
- •Subjects unable to give informed consent
研究组 & 干预措施
24 months of P2Y12 receptor antagonist
Receive 24 months of dual antiplatelet therapy (with a P2Y12 receptor antagonist in addition to aspirin) after index procedure. All subjects receive aspirin for the duration of study.
干预措施: 24 months of P2Y12 receptor antagonist (Drug)
24 months of P2Y12 receptor antagonist
Receive 24 months of dual antiplatelet therapy (with a P2Y12 receptor antagonist in addition to aspirin) after index procedure. All subjects receive aspirin for the duration of study.
干预措施: Aspirin (Drug)
12 months of P2Y12 receptor antagonist
Receive 12 months of dual antiplatelet therapy (with a P2Y12 receptor antagonist in addition to aspirin) after index procedure. All subjects receive aspirin for the duration of study.
干预措施: 12 months of P2Y12 receptor antagonist (Drug)
12 months of P2Y12 receptor antagonist
Receive 12 months of dual antiplatelet therapy (with a P2Y12 receptor antagonist in addition to aspirin) after index procedure. All subjects receive aspirin for the duration of study.
干预措施: Aspirin (Drug)
结局指标
主要结局
MACCE
时间窗: 24 months
Incidence of a composite end point including all cause deaths, myocardial infarction, the incidence of Academic Research Consortium defined definite or probable stent thrombosis and stroke (MACCE) at 24 months.
次要结局
- Safety end point assessed by incidence of GUSTO moderate or severe bleeding.(24 months)
研究者
Yujie Zhou
professor of cardiology, vice president of Beijing Anzhen Hospital
Beijing Anzhen Hospital