NCT00222261

Aspirin Non-responsiveness and Clopidogrel Endpoint Trial.

• Status: Completed
• Phase: Phase 4
• Study type: Interventional
• Enrollment: 1,001 (actual)
• Sponsor: Ullevaal University Hospital · Academic / Other
• Sex: All
• Age: 18 Years – 80 Years
• Healthy volunteers: Not accepted

Summary

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.

Detailed description

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.

Conditions

• Coronary Heart Disease
• Angina Pectoris
• Atherosclerosis

Interventions

Type	Name	Description
DRUG	aspirin	Aspirin 160 mg once daily for two years
DRUG	clopidogrel	clopidogrel 75 mg once daily for two years

Timeline

• Start date: 2003-04-01
• Primary completion: 2010-07-01
• Completion: 2010-07-01
• First posted: 2005-09-22
• Last updated: 2011-03-23

Locations

1 site across 1 country: Norway