Stroke Trials Registry

CAPRIE
Clopidogrel vs. Aspirin in Patients at Risk of Ischemic Events

Principal Investigator
CAPRIE Steering Committee

Contact Address
Prof M Gent, Clinical Trials Methodology Group, Hamilton Civic Hospitals Research Centre, 711 Concession Street, Hamilton, Ontario, Canada L8V 1C3

Trial Phase:	Phase III
Study Size Actual:	19185
Centers Actual:	384
Min Age:	21

Status:
Trial complete. Results published in January of 1996.

Purpose:
To test the relative efficacy of clopidogrel (75 mg once daily ) and aspirin (325 mg once daily) for prevention of stroke, myocardial infarction or vascular death.

Interventions:

Aspirin (stroke prevention)
Antiplatelet agent; inhibits thromboxane A2

Clopidogrel
Antiplatelet agent

Year Published: 1996

Design:
Randomized, double-blind, international trial of 19,185 patients at 384 centers in 16 countries.

Inclusion Criteria
Atherosclerotic vascular disease manifested as either recent ischemic stroke, recent myocardial infarction, or symptomatic peripheral arterial disease.

Exclusion Criteria
< 21 years of age, severe cerebral deficit, carotid endarterectomy after qualifying stroke, qualifying stroke induced by carotid endarterectomy or angiography, patient unlikely to be discharged alone after qualifying event, severe co-morbidity likely to limit patient's life expectancy to < 3 years, uncontrolled hypertension, scheduled for major surgery, contrainidications to study drugs, women of childbearing age not using reliable contraception, currently receiving investigation drug, previously entered in other clopidogrel studies, geographic or other factors making study participation impractical.

Primary Outcome:
Ischemic stroke, myocardial infarction, or vascular death during 1-3 year follow-up period.

Results:
Patients treated with clopidogrel had a 5.32% annual risk of ischemic stroke, myocardial infarction or vascular death whereas patients treated with aspirin had a 5.83% annual risk of the same events. These rates show a statistically significant (p=0.043) relative-risk reduction of 8.7% in favor of clopidogrel (95% CI 0.3-16.5).

Source of Information:
Circulation 2001 Jan 23;103(3):363-368.

Web Links and Publications:

Superiority of Clopidogrel Versus Aspirin in Patients With Prior Cardiac Surgery.
Circulation 2001 Jan 23;103(3):363-368.

Comparative safety and tolerability of clopidogrel and aspirin: results from CAPRIE. CAPRIE Steering Committee and Investigators. Clopidogrel versus aspirin in patients at risk of ischaemic events.
Drug Saf. 1999 Oct;21(4):325-35

The results of CAPRIE, IST and CAST. Clopidogrel vs. Aspirin in Patients at Risk of Ischaemic Events. International Stroke Trial. Chinese Acute Stroke Trial.
Thromb Res. 1998 Sep 15;92(1 Suppl 1):S13-6.

A randomised, blinded, trial of clopidogrel versus aspirin in patients at risk of ischaemic events (CAPRIE). CAPRIE Steering Committee.
Lancet 1996 Nov 16;348(9038):1329-1339

This information last updated on: 7/5/2001

UID: 10