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临床试验/NCT00222261
NCT00222261已完成4 期

Aspirin Non-responsiveness and Clopidogrel Endpoint Trial.

Ullevaal University Hospital1 个研究点 分布在 1 个国家目标入组 1,001 人开始时间: 2003年4月最近更新:
适应症
干预措施
相关药物

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

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

Active Comparator

Aspirin 160 mg

干预措施: aspirin (Drug)

2, clopidogrel

Active Comparator

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)

研究者

发起方
Ullevaal University Hospital
申办方类型
Other

研究点 (1)

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