CAPRIE

Introduction

Secondary prevention of MI, stroke and vascular death: Clopidogrel versus Aspirin in Patients at Risk of Ischemic Events (CAPRIE) trial

To assess the potential benefit of clopidogrel vs aspirin, in reducing the risk of cardiovascular events in patients with recent ischaemic stroke, recent myocardial infarction (MI), or peripheral arterial disease (PAD)

Study Patients

Patients with manifestations of atherosclerotic disease (recent ischemic stroke, recent MI or PAD) (N = 19185)

Study Groups

Clopidogrel 75 mg/day
Aspirin 325 mg/day

Study Follow-up

1-3 years (mean follow up - 1.9 years)

Results

In patients treated with clopidogrel, the risk of MI, ischemic stroke or vascular death was reduced by 8.7%

It is important to realize that clopidogrel was not compared with placebo, but with aspirin. Aspirin itself provides a 25% risk reduction compared with placebo. Hence the 8.7% risk reduction with clopidogrel is additional to the 25% reduction provided by aspirin.

In patients with stroke, the risk of MI, ischemic stroke and PAD was reduced by 7.3% while in patients with PAD, this risk was reduced by 23.8% and in patients with previous MI, this risk was reduced by 7.4%.

Additional analysis showed that MI alone was reduced by 19.2% with clopidogrel as compared to aspirin.

Safety

Clopidogrel was well tolerated. The discontinuation rate was similar in both drugs with frequency of rash & diarrhea higher in clopidogrel group while GI side effects higher in aspirin group.

Conclusions

Given this favourable efficacy/safety ratio, clopidogrel is an effective antiplatelet agent & better than aspirin for management of atherothrombotic disease.

Lancet 1996; 348: 1329-1339

0