A randomised, blinded, trial of clopidogrel versus aspirin in patients at risk of ischaemic events (CAPRIE)

Many clinical trials have evaluated the benefit of long-term use of antiplatelet drugs in reducing the risk of clinical thrombotic events. Aspirin and ticlopidine have been shown to be effective, but both have potentially serious adverse effects. Clopidogrel, a new thienopyridine derivative similar...

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Veröffentlicht in:The Lancet (British edition) 1996-11, Vol.348 (9038), p.1329-1339
1. Verfasser: CAPRIE Steering Committee
Format: Artikel
Sprache:eng
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Zusammenfassung:Many clinical trials have evaluated the benefit of long-term use of antiplatelet drugs in reducing the risk of clinical thrombotic events. Aspirin and ticlopidine have been shown to be effective, but both have potentially serious adverse effects. Clopidogrel, a new thienopyridine derivative similar to ticlopidine, is an inhibitor of platelet aggregation induced by adenosine diphosphate. CAPRIE was a randomised, blinded, international trial designed to assess the relative efficacy of clopidogrel (75 mg once daily) and aspirin (325 mg once daily) in reducing the risk of a composite outcome cluster of ischaemic stroke, myocardial infarction, or vascular death; their relative safety was also assessed. The population studied comprised subgroups of patients with atherosclerotic vascular disease manifested as either recent ischaemic stroke, recent myocardial infarction, or symptomatic peripheral arterial disease. Patients were followed for 1 to 3 years. 19 185 patients, with more than 6300 in each of the clinical subgroups, were recruited over 3 years, with a mean follow-up of 1 91 years. There were 1960 first events included in the outcome cluster on which an intention-to-treat analysis showed that patients treated with clopidogrel had an annual 5 32% risk of ischaemic stroke, myocardial infarction, or vascular death compared with 5 83% with aspirin. These rates reflect a statisticaly significant (p=0 043) relative-risk reduction of 8 7% in favour of clopidogrel (95% CI 03–165). Corresponding on-treatment analysis yielded a relative-risk reduction of 9–4%. There were no major differences in terms of safety. Reported adverse experiences in the clopidogrel and aspirin groups judged to be severe included rash (0–26% i/s0–10%), diarrhoea (0–23% vs 0 11%), upper gastrointestinal discomfort (0–97% vs 1 22%), intracranial haemorrhage (0–33% vs 0–47%), and gastrointestinal haemorrhage (0–52% vs 0–72%), respectively. There were ten (0–10%) patients in the clopidogrel group with significant reductions in neutrophils (
ISSN:0140-6736
1474-547X
DOI:10.1016/S0140-6736(96)09457-3