CAPRIE
Trial question
Is clopidogrel superior to aspirin in patients with atherosclerotic vascular disease?
Study design
Multi-center
Double blinded
RCT
Population
Characteristics of study participants
28.0% female
72.0% male
N = 19185
19185 patients (5372 female, 13813 male).
Inclusion criteria: patients with atherosclerotic vascular disease.
Key exclusion criteria: age < 21 years, women of childbearing age not using reliable contraception, uncontrolled hypertension, scheduled for major surgery, or contraindications to study drugs.
Interventions
N=9599 clopidogrel (75 mg daily).
N=9586 aspirin (325 mg daily).
Primary outcome
Ischemic stroke, MI, or vascular death
5.32%
5.83%
5.8 %
4.4 %
2.9 %
1.5 %
0.0 %
Clopidogrel
Aspirin
Significant
decrease ▼
NNT = 196
Significant decrease in ischemic stroke, MI, or vascular death (5.32% vs. 5.83%; RR 0.91, 95% CI 0.84 to 0.97).
Secondary outcomes
No significant difference in ischemic stroke, MI, amputation, or vascular death (5.56% vs. 6.01%; RR 0.92, 95% CI 0.85 to 1.08).
Safety outcomes
No significant difference in adverse events.
Conclusion
In patients with atherosclerotic vascular disease, clopidogrel was superior to aspirin with respect to ischemic stroke, MI, or vascular death.
Reference
CAPRIE Steering Committee. 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):1329-39.
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