Aspirin Non-responsiveness and Clopidogrel Endpoint Trial.

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.

Conditions

• Coronary Heart Disease
• Angina Pectoris
• Atherosclerosis

Interventions

DRUG

aspirin

Aspirin 160 mg once daily for two years

DRUG

clopidogrel

clopidogrel 75 mg once daily for two years

Sponsors & Collaborators

• The Norwegian Council for Cardiovascular Diseases.

  collaborator UNKNOWN

• Ada and Hagbart Waages Humanitarian and Charity Foundation

  collaborator OTHER

• Alf and Aagot Helgesens Research Foundation.

  collaborator UNKNOWN

• Ullevaal University Hospital

  lead OTHER

Principal Investigators

• Alf-Aage R. Pettersen, M.D. · Dept. of Cardiology, Ullevaal University Hospital, Oslo

• Harald Arnesen, M.D. Ph.D. · Center for Clinical Cardiovascular Research, Ullevaal University Hospital, Oslo

• Ingebjorg Seljeflot, Ph.D. · Center for Clinical Cardiovascular Research, Ullevaal University Hospital, Oslo

• Michael Abdelnoor, Ph.D. · Center for Clinical Cardiovascular Research, Ullevaal University Hospital, Oslo

• Arne Westheim, M.D. Ph.D · Dept. of Cardiology, Ullevaal University Hospital, Oslo

Study Design

Allocation

RANDOMIZED

Purpose

TREATMENT

Masking

NONE

Model

PARALLEL

Eligibility

Min Age

18 Years

Max Age

80 Years

Sex

ALL

Healthy Volunteers

No

Timeline & Regulatory

Start

2003-04-30

Primary Completion

2010-07-31

Completion

2010-07-31

Countries

• Norway

Study Locations