Clopidogrel High Dose Evaluation for the Patient With Coronary Artery Disease in Japan
试验速览
- 阶段
- 4 期
- 状态
- 已完成
- 发起方
- 入组人数
- 106
- 试验地点
- 1
- 主要终点
- Inhibition of platelet aggregation 24 hours after loading
研究概览
简要总结
The purpose of this study is to evaluate the effect of high dose clopidogrel as the antiplatelet therapy on inhibition of platelet aggregation in Japanese patients scheduled for percutaneous coronary intervention due to ischemic heart disease.
详细描述
Dual antiplatelet therapy of aspirin and thienopyridine is used to prevent stent thrombosis after percutaneous coronary intervention (PCI). Clopidogrel is the most popular thienopyridine. Following the 300mg clopidogrel loading dose (LD) at first day, patients take 75mg maintenance dose (MD) to inhibit platelet aggregation after coronary stent implantation. 600mg high LD inhibit platelet aggregation more rapidly and strongly than standard LD and prevent thrombotic event around the PCI. Similarly high MD inhibit platelet aggregation more strongly. Interindividual variability of clopidogrel anti-platelet effect has been reported. In Japanese, there are many non or hyporesponders to clopidogrel compared to the Western population. The purpose of this study is to evaluate the effect of high dose clopidogrel as the antiplatelet therapy on inhibition of platelet aggregation in Japanese patients scheduled for PCI due to ischemic heart disease.
研究设计
- 研究类型
- Interventional
- 分配方式
- Randomized
- 干预模型
- Factorial
- 主要目的
- Treatment
- 盲法
- None
入排标准
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •Patients scheduled for percutaneous coronary intervention due to ischemic heart disease
- •Patients taking aspirin 81-100mg at least 1 week.
排除标准
- •Patients with ST elevation myocardial infarction
- •Patients have contraindication of aspirin or clopidogrel
- •Patients taking warfarin
- •Patients received thrombolytic therapy within 2 weeks
- •Patients taking anti-platelet agents except aspirin within 1 month
- •Patients taking corticosteroid.
- •Patients taking proton pump inhibitor
研究组 & 干预措施
High loading and high maintenance
Clopidogrel loading 600mg and maintenance 150mg for 7days
干预措施: Clopidogrel (Drug)
High loading and low maintenance
Clopidogrel loading 600mg and maintenance 75mg for 7days
干预措施: Clopidogrel (Drug)
Low loading and high maintenance
Clopidogrel loading 300mg and maintenance 150mg for 7days
干预措施: Clopidogrel (Drug)
Low loading and low maintenance
Clopidogrel loading 300mg and maintenance 75mg for 7days
干预措施: Clopidogrel (Drug)
结局指标
主要结局
Inhibition of platelet aggregation 24 hours after loading
时间窗: 24 hours
次要结局
- cardiac death(1 year)
- bleeding complications (Global Use of Strategies to Open Occluded Coronary Arteries [GUSTO] and Thrombolysis In Myocardial Infarction [TIMI] definition)(1 year)
- Inhibition of platelet aggregation 7 days after loading(7 days)
- all cause death(1 year)
- stent thrombosis (Academic Research Consortium definition)(1 year)
- composite of cardiac death, myocardial infarction and stroke(1 year)
- Inhibition of platelet aggregation 28 days after loading(28 days)
- myocardial infarction(1 year)
- acute hemorrhagic or ischemic stroke excluding transient ischemic attack(1 year)
研究者
Takeshi Morimoto
Professor
Kyoto University, Graduate School of Medicine