NCT00638326终止3 期
150 mg Maintenance Dose of Clopidogrel in Patients With High On-Clopidogrel Platelet Reactivity After Elective Percutaneous Coronary Intervention
适应症
干预措施
相关药物
试验速览
- 阶段
- 3 期
- 状态
- 终止
- 入组人数
- 500
- 试验地点
- 1
- 主要终点
- Cardiac death or non-fatal myocardial infarction or ischemia-driven target vessel revascularisation.
研究概览
简要总结
The purpose of the study is to determine whether administration of 150 mg clopidogrel is effective in reducing the one-year incidence of thromboischemic events in patients with high on-clopidogrel platelet reactivity compared to 75 mg clopidogrel after elective percutaneous coronary intervention.
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
- Quadruple (Participant, Care Provider, Investigator, 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
- •Clopidogrel-naïve stable angina pectoris (CCS I-III)
- •Coronary angiography that reveals significant DE NOVO coronary stenosis (diameter stenosis greater than 50% in two independent projections) feasible for ad hoc stent implantation
排除标准
- •Acute coronary syndrome (STEMI, NSTEMI or unstable angina)
- •Administration of clopidogrel/ticlopidine/coumarin in the past 6 weeks
- •Contraindication to antiplatelet therapy
- •Significant LM stenosis
- •PCI due to instent restenosis
- •Lesion located in bypass grafts
- •Stroke in past one year
- •Reduced life expectancy
研究组 & 干预措施
2
Experimental
Patients who show suboptimal response to 600 mg loading dose of clopidogrel and receive 1x150 mg clopidogrel for 28 days
干预措施: clopidogrel (Drug)
3
Active Comparator
Patients who show suboptimal response to 600 mg loading dose of clopidogrel and receive 1x75 mg clopidogrel
干预措施: clopidogrel plus placebo (Drug)
结局指标
主要结局
Cardiac death or non-fatal myocardial infarction or ischemia-driven target vessel revascularisation.
时间窗: 12 months
次要结局
- Cardiac death and non-fatal myocardial infarction(12 months)
- Academic Research Consortium (ARC) definite / probable stent thrombosis(12 months)
- Cardiac death or non-fatal myocardial infarction or ischemia-driven target vessel revascularisation or TIMI major/minor bleeding(12 months)
- 5 microM ADP-induced platelet aggregation assessed by light transmission aggregometer(25 +/-2 days)
- VASP-PRI(25 +/-2 days)
研究者
研究点 (1)
Loading locations...
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