Aspirin Non-responsiveness and Clopidogrel Endpoint Trial.

• Status: Completed
• Trial end date: 2010-07-01
• Target enrollment: 0
• Participant gender: All

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.

• Phase: Phase 4
• Accepts Healthy Volunteers?: No

Details

• Lead Sponsor: Ullevaal University Hospital
• Collaborators: Ada and Hagbart Waages Humanitarian and Charity Foundation; Alf and Aagot Helgesens Research Foundation.; The Norwegian Council for Cardiovascular Diseases.
• Treatments: Aspirin; Clopidogrel; Ticlopidine

Criteria

Inclusion Criteria:

• Stable, symptomatic coronary heart disease, verified by coronary angiography, being treated with angioplasty/stent implantation (PCI) or not.

Exclusion Criteria:

• 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.