CAPRIE: Clopidogrel versus Aspirin in Patients at risk of Ischemic Events Purpose To assess the relative efficacy of the antiplatelet drugs clopidogrel.

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CAPRIE: Clopidogrel versus Aspirin in Patients at risk of Ischemic Events Purpose To assess the relative efficacy of the antiplatelet drugs clopidogrel and aspirin in reducing the risk of thrombotic events in patients with atherosclerotic disease. Reference CAPRIE Steering Committee. A randomised, blinded, trial of clopidogrel versus aspirin in patients at risk of ischaemic events (CAPRIE). Lancet 1996;348:1329–39.

CAPRIE: Clopidogrel versus Aspirin in Patients at risk of Ischemic Events - TRIAL DESIGN - Multicenter, multinational, randomized, double-blind, parallel group Patients 19,185 patients with atherosclerotic vascular disease (either recent ischemic stroke, recent MI or symptomatic peripheral arterial disease) Follow up and primary endpoint Primary combined endpoint: ischemic stroke, MI or vascular death. Mean 1.9 years follow up. Treatment Aspirin 325 mg once daily or clopidogrel 75 mg once daily

CAPRIE: Clopidogrel versus Aspirin in Patients at risk of Ischemic Events - TRIAL DESIGN continued- Patient subgroups Aspirin (n=9586) Clopidogrel (n=9599) Stroke 33.4% 33.7% MI 32.9% 32.7% Peripheral arterial disease 33.7% 33.6% CAPRIE Steering Committee. Lancet 1996; 348 :1329–39.

CAPRIE: Clopidogrel versus Aspirin in Patients at risk of Ischemic Events - RESULTS - Annual event rate for primary endpoint of ischemic stroke, MI or vascular death significantly reduced in clopidogrel group compared with aspirin (5.32 vs. 5.83%, p<0.043) Effect of clopidogrel compared with aspirin indicated that benefit may not be identical between subgroups (p=0.042 for test of heterogeneity): reduction in event rate was significant in patients with existing peripheral arterial disease reduction in the group with previous stroke, though not significant increased event rate in the group with previous MI, though not significant Clopidogrel was well tolerated as defined by withdrawal rate from trial: only marginally higher vs aspirin (21.3 vs. 21.1%)

CAPRIE: Clopidogrel versus Aspirin in Patients at risk of Ischemic Events - RESULTS continued - Primary endpoint: stroke, MI or vascular death Cumulative 20 risk (%) 15 10 5 Aspirin Clopidogrel p=0.043 6 12 18 24 30 36 Months after randomization CAPRIE Steering Committee. Lancet 1996; 348 :1329–39.

CAPRIE: Clopidogrel versus Aspirin in Patients at risk of Ischemic Events - RESULTS continued - Primary endpoint by subgroup Subgroup Treatment group (patient years at risk) Events per year (%) p Relative risk reduction (95% CI) Relative risk reduction (%) Aspirin better Clopidogrel better Stroke Clopidogrel (6054) 7.15 7.3% 0.26 Aspirin (5979) 7.71 (–5.7 to 18.7) MI Clopidogrel (5787) 5.03 –3.7% 0.66 Aspirin (5843) 4.84 (–22.1 to 12.0) Peripheral arterial disease Clopidogrel (5795) 3.71 23.8% 0.0028 Aspirin (5797) 4.86 (8.9 to 36.2) All patients Clopidogrel (17,636) 5.32 8.7% 0.043 Aspirin (17,519) 5.83 (0.3 to 16.5) –30 –20 –10 10 20 30 40 CAPRIE Steering Committee. Lancet 1996; 348 :1329–39.

CAPRIE: Clopidogrel versus Aspirin in Patients at risk of Ischemic Events - RESULTS continued- Stroke and MI Aspirin Clopidogrel Patient years at risk 17,519 17,636 Stroke Nonfatal 430 405 Fatal 32 33 MI Nonfatal 270 226 Fatal 63 49 CAPRIE Steering Committee. Lancet 1996; 348 :1329–39.

CAPRIE: Clopidogrel versus Aspirin in Patients at risk of Ischemic Events - SUMMARY - Compared with aspirin, in patients with atherosclerotic vascular disease, clopidogrel: Reduced the primary combined endpoint of stroke, MI or vascular death in the total study population Conferred benefit in peripheral arterial disease and stroke subgroups Conferred no significant benefit in previous MI subgroup

CAPRIE: Clopidogrel versus Aspirin in Patients at risk of Ischemic Events - SUMMARY - Compared with aspirin, in patients with atherosclerotic vascular disease, clopidogrel: Reduced the primary combined endpoint of stroke, MI or vascular death in the total study population Conferred benefit in peripheral arterial disease subgroup Conferred no significant change in risk in stroke and MI subgroups