Pilot Study of Personal Optimized Antiplatelet Treatment After Percutaneous Coronary Intervention in Patients With Acute Coronary Syndromes
试验速览
- 阶段
- 4 期
- 状态
- 已完成
- 发起方
- 入组人数
- 305
- 试验地点
- 1
- 主要终点
- Major adverse cardiac and cerebral events at 1 year
研究概览
简要总结
Effects of dual antiplatelet therapy with aspirin and clopidogrel after percutaneous coronary intervention has been proven. However, patients with low response to those agents are reported be associated with adverse clinical outcomes. We suppose that optimized antiplatelet therapy for individual patients based on platelet function assay may improve long-term outcomes especially in patients with high risk of thrombosis. In this prospective randomized study, patients in control group all receive standard dual antiplatelet therapy, and patients in optimized group receive different antiplatelet therapy according to risk stratification.
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
- 35 Years 至 75 Years（Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •non-ST-segment elevated acute coronary syndromes
- •patients undergoing selective or emergent PCI
排除标准
- •administration of clopidogrel or ticlopidine within 2 weeks
- •ST-segment elevated myocardial infarction
- •contraindications of antiplatelet therapy
- •history of intracranial bleeding
- •known bleeding disorders
- •severe liver or kidney disease
研究组 & 干预措施
optimal antiplatelet
cilostazol in addition to aspirin and clopdidogrel for pts with clopidogrel resistance
干预措施: cilostazol in addition to aspirin and clopidogrel (Drug)
standard antiplatelet
aspirin and clopidogrel for all patients
干预措施: cilostazol in addition to aspirin and clopidogrel (Drug)
结局指标
主要结局
Major adverse cardiac and cerebral events at 1 year
时间窗: 1 year
次要结局
- Hemorrhage events at 1 year(1 year)