Effects of Intensive Antiplatelet Therapy for Patients With Clopidogrel Resistance After Coronary Stent Implantation
试验速览
- 阶段
- 4 期
- 状态
- 已完成
- 发起方
- 入组人数
- 840
- 试验地点
- 3
- 主要终点
- Major ischemic cardiovascular events
研究概览
简要总结
Clopidogrel resistance (CR) or low-responsiveness is associated with increased risk of ischemic events and can be detected by laboratory tests. This multicenter, randomized study is aimed to explore the efficacy and safety of intensive antiplatelet therapy (i.e. double clopidogrel maintenance dose and/or additional cilostazol)for patients with CR after coronary stenting.
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
- Single (Outcomes Assessor)
入排标准
- 年龄范围
- 35 Years 至 75 Years（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
- •contraindications to antiplatelet therapy
- •history of intracranial bleeding
- •known bleeding disorders
- •severe liver or kidney disease
- •pregnancy
- •left main coronary artery disease
- •planned non cardiac surgery within 1 year
- •end stage of other serious disease with life expectancy less than 1 year
- •heart failure with NYHA grade 3 to 4
研究组 & 干预措施
standard group
patients in this group received standard dual antiplatelet therapy, i.e. aspirin 300mg/d and clopidogrel 75mg/d
干预措施: aspirin, clopidogrel (Drug)
intensive group
patients in this group received intensive antiplatelet therapy and the regimen can be adjusted according to results of platelet aggregation function test by LTA
干预措施: aspirin, clopidogrel, cilostazol (Drug)
结局指标
主要结局
Major ischemic cardiovascular events
时间窗: 1 year
defined as a composite of cardiac death, myocardial infarction or stroke
次要结局
- reduction in ADP induced platelet aggregation(30 days)
- Stent thrombosis(1 year)
- major adverse cardiac and cerebral events(MACCE)(1 year)
- Hemorrhagic events(within 1 year)
研究者
Yaling Han
vice president
Shenyang Northern Hospital