Authors
CAPRIE Steering Committee
Title
A randomised, blinded, trial of clopidogrel versus aspirin in patients at risk of ischaemic events (CAPRIE)
References
Lancet 1996;348:1329-1339.
Background
Both aspirin and ticlopidine have been shown in clinical trials to decrease the risk of thrombotic events. Both drugs have particular side effects (eg. Bone marrow depression with ticlopidine). Clopidogrel, a thienopyridine has the same mechanism of action as ticlopidine with a different side effect profile.
Purpose
To compare the benefit of clopidogrel versus aspirin in reducing the risk of ischemic stroke, myocardial infarction, or vascular death in subgroups of patients with atherosclerotic vascular disease (recent ischemic stroke, recent myocardial infarction, or symptomatic peripheral artery disease). To assess the safety of clopidogrel compared to aspirin.
Design
  • Randomised, double blind, placebo controlled trial
  • 19,185 patients, age ≥ 21 years, with atherosclerotic vascular disease: recent acute myocardial infarction, stroke, or symptomatic peripheral artery disease
Exclusion Criteria
None.
Follow-Up
1-3 years (mean duration: 1.91 years)
Treatment Regimen
Clopidogrel 75 mg once daily or; Aspirin 325 mg once daily
Results

Primary Endpoint: Composite of ischemic stroke, MI, or vascular death

Ischemic stroke, myocardial infarction, or vascular death was 5.32% (clopidogrel) versus 5.83% (aspirin); p=0.043 (relative risk reduction of 8.7%). Sub-group analysis showed that the primary endpoint was statistically significantly reduced in the patients with peripheral arterial disease (3.71% versus 4.86%; p=0.0028). There were no major differences in terms of safety outcomes.

Summary
Clopidogrel is more effective than aspirin in patients with atherosclerotic vascular disease in reducing the composite endpoint of ischemic stroke, myocardial infarction, or vascular death, without increasing serious adverse side effects.
Implications
None.
Related Figures
[5, 7, 8]