CHAMP

Combination Hemotherapy And Mortality Prevention (2002) 

Condition

Secondary prevention of vascular events and death after acute myocardial infarction

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Objective

To investigate, whether ASA and warfarin, when combined in moderate doses, would be more effective than ASA alone in reducing all-cause mortality following acute myocardial infarction

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Trial design

Randomized, open-label study
Active treatment: warfarin (INR 1.5–2.5) plus ASA 81 mg once daily (n=2522)
Control treatment: ASA 162 mg once daily (n=2537)

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Endpoints

Primary efficacy endpoint: all-cause mortality
Secondary efficacy endpoints: recurrent myocardial infarction, stroke, vascular mortality, composite of recurrent myocardial infarction, or stroke
Primary safety endpoint: major hemorrhagic events

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Trial participants

5059 patients (mean age 64 years) who sustained an acute myocardial infarction within the preceding 14 days

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Results

Efficacy outcome: During the mean follow-up of 2.7 years, 438 of 2537patients (17.3%) assigned to ASA and 444 of the 2522 patients (17.6%) assigned to warfarin plus ASA died. Recurrent myocardial infarction occurred in 333 patients (13.1%) given ASA and in 336 patients (13.3%) given the combination therapy. Stroke occurred in 89 patients (3.5%) receiving ASA and in 79 patients (3.1%) receiving warfarin plus ASA
Safety outcome: Major bleeding was observed in 50 patients treated with ASA and in 87 patients treated with the combination (1.28 vs. 0.72 events per 100 person years). 77 patients on ASA and 349 on the combination therapy suffered from minor bleedings (1.11 vs. 5.14 events per 100 person years)

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Summary

Efficacy: In post-myocardial infarction patients, moderate-dose warfarin (INR 1.5–2.5) combined with low-dose ASA was not superior to ASA monotherapy in reducing all-cause mortality and cardiovascular events
Safety: Major and minor bleeding occurred more frequently in the combination therapy group than in the ASA group

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Reference

Fiore LD, Ezekowitz MD, Brophy MT, Lu D, Sacco J, Peduzzi P, for the Combination Hemotherapy and Mortality Prevention (CHAMP) study group. Department of Veterans Affairs Cooperative Studies Program clinical trial comparing combined warfarin and aspirin with aspirin alone in survivors of acute myocardial infarction: Primary results of the CHAMP study. Circulation 2002;105:557-563

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Corresponding author

Louis Fiore, MD, Department of Veterans Affairs Cooperative Studies Program Coordinating Center, VA Boston Healthcare System, 150 S Huntington Ave, Boston, MA 02130, e-mail: louis.fiore@med.va.gov

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