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Aspirin Non-responsiveness and Clopidogrel Endpoint Trial.

Aspirin Non-responsiveness and Clopidogrel Endpoint Trial.

Status
Completed
Phases
Phase 4
Study type
Interventional
Source
ClinicalTrials.gov
Registry ID
NCT00222261
Acronym
ASCET
Enrollment
1001
Registered
2005-09-22
Start date
2003-04-30
Completion date
2010-07-31
Last updated
2011-03-23

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

Angina Pectoris, Atherosclerosis, Coronary Heart Disease

Keywords

antiplatelet therapy, aspirin non-responders, aspirin resistance, clopidogrel, coronary heart disease, stable angina pectoris

Brief 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.

Interventions

DRUGaspirin

Aspirin 160 mg once daily for two years

DRUGclopidogrel

clopidogrel 75 mg once daily for two years

Sponsors

The Norwegian Council for Cardiovascular Diseases.
CollaboratorUNKNOWN
Ada and Hagbart Waages Humanitarian and Charity Foundation
CollaboratorOTHER
Alf and Aagot Helgesens Research Foundation.
CollaboratorUNKNOWN
Ullevaal University Hospital
Lead SponsorOTHER

Study design

Allocation
RANDOMIZED
Intervention model
PARALLEL
Primary purpose
TREATMENT
Masking
NONE

Eligibility

Sex/Gender
ALL
Age
18 Years to 80 Years
Healthy volunteers
No

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.

Design outcomes

Primary

MeasureTime frame
Mortality2 years
Myocardial infarction2 years
Unstable angina with ECG changes or raised levels of cardiac markers not to be classified as a myocardial infarction2 years

Secondary

MeasureTime frame
Instent restenosis and/or thrombosis detected by coronary angiography.2 years

Countries

Norway

Outcome results

None listed

Source: ClinicalTrials.gov · Data processed: Mar 29, 2026