ASPECT-2

Antithrombotics in the Secondary Prevention of Events in Coronary Thrombosis-2 (2002)

Condition

Prevention of reocclusion and recurrent ischemic events after acute coronarysyndromes

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Objective

To assess the effect of high-intensity anticoagulation and ASA plus moderate-intensity anticoagulation, compared to ASA alone in patients with anacute coronary event

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Trial design

Randomized, controlled open-label study
Active treatment: warfarin (INR 3.0-4.0) (n=330), or low-dose ASA (80 mgonce daily) plus warfarin (INR 2.0-2.5) (n=333)
Control treatment: ASA 80 mg once daily (n=336)

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Endpoints

Primary efficacy endpoint: composite of death, myocardial infarction, orstroke
Secondary efficacy endpoint: death from all causes (vascular death, myocardialinfarction, unstable angina, cardiac interventions, and stroke)
Safety endpoints: major and minor bleeding

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Trial participants

999 patients (mean age 61 years) admitted with acute myocardial infarctionor unstable angina within the preceding 8 weeks

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Results

Efficacy outcome: The primary endpoint was reached in 31 of 336 patients(9%) on ASA, in 17 of 325 patients (5%) on warfarin, and in 16 of 332 patients(5%) on ASA plus warfarin
Safety outcome: Major bleeding was recorded in 3 patients (1%) on ASA,3 patients (1%) on warfarin, and 7 patients (2%) on ASA plus warfarin. Thefrequency of minor bleeding was 5%, 8% and 15%, respectively

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Summary

Efficacy: In patients recently admitted with acute coronary syndromes,treatment with high-intensity warfarin or ASA plus moderate-intensity warfarinwas more effective than ASA alone in the reduction of recurrent cardiovascularevents and death
Safety: Treatment with ASA plus warfarin was associated with an insignificanttwo-fold increase in major bleeding and a significant three-fold increasein minor bleeding

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Reference

Van Es RF, Jonker JJC, Verheugt FWA, Deckers JW, Grobbee DE, for theASPECT-2 Research Group. Aspirin and coumadin after acute coronarysyndromes (the ASPECT-2 study): a randomised controlled trial. Lancet2002;360:109-113

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Corresponding author

Prof. Diederick Grobbee, Julius Centre for General Practice and Patient Oriented Research, University Medical Centre Utrecht, PO Box 85500, 3508 GA Utrecht, Netherlands, e-mail: d.e.grobbee@jc.azu.nl

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