Aspirin Non-responsiveness and Clopidogrel Endpoint Trial.
试验速览
- 阶段
- 4 期
- 状态
- 已完成
- 发起方
- 入组人数
- 1,001
- 试验地点
- 1
- 主要终点
- Mortality
研究概览
简要总结
In the ASCET study, 1000 patients with documented coronary heart disease will be randomized to either continued treatment with aspirin 160 mg/d or change to clopidogrel 75mg/d. Clinical endpoints will be recorded for at least 2 years and related to the initial aspirin response, assessed by the PFA-100® method, to investigate whether aspirin non-responders have higher composite event rate than responders or whether Clopidogrel treatment in patients non-responsive to aspirin will reduce their risk of future clinical events. The clinical events are the composite of unstable angina, myocardial infarction, stroke or death.
详细描述
Background: Aspirin is widely used as an antiplatelet drug in patients with coronary heart disease. Despite documented clinical benefit, many patients on aspirin still experience severe cardiovascular events. Several laboratory reports have shown lack of platelet inhibition in 5-40% of aspirin-treated patients, and the term aspirin resistance has been introduced. The clinical relevance of these laboratory findings is, however, still unknown. New antiplatelet drugs have been developed, and the adenosin diphosphate (ADP) receptor inhibitor clopidogrel has at least the same efficacy as aspirin with an acceptable safety profile. Laboratory methods for determination of platelet reactivity and treatment efficacy have been complicated and time consuming. New methodologies, like the PFA-100® system, have made such analyses more suitable for clinical use.
Design: In the ASCET study, 1000 patients with documented coronary heart disease will be randomized to either continued treatment with aspirin 160 mg/d or change to clopidogrel 75mg/d after initial determination of their platelet reactivity while on aspirin treatment. Clinical endpoints will be recorded for at least 2 years and related to the initial aspirin response.
Scand Cardiovasc J. 2004 Dec;38(6):353-6.
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
- •Stable, symptomatic coronary heart disease, verified by coronary angiography, being treated with angioplasty/stent implantation (PCI) or not.
排除标准
- •Indication for warfarin treatment.
- •Indication for or contraindication to the study drugs.
- •Pregnancy or breast-feeding.
- •Malignancy that may interfere with life expectancy.
- •Psychiatric disease, mental retardation, dementia, drug abuse, alcoholism or conditions that can severely reduce compliance.
研究组 & 干预措施
1, aspirin
Aspirin 160 mg
干预措施: aspirin (Drug)
2, clopidogrel
Clopidogrel 75 mg
干预措施: clopidogrel (Drug)
结局指标
主要结局
Mortality
时间窗: 2 years
Myocardial infarction
时间窗: 2 years
Unstable angina with ECG changes or raised levels of cardiac markers not to be classified as a myocardial infarction
时间窗: 2 years
次要结局
- Instent restenosis and/or thrombosis detected by coronary angiography.(2 years)
