RE-DEEM

Dabigatran versus placebo in patients with acute coronary syndromes on dual antiplatelet therapy (2011)

Condition

Secondary prevention in ACS

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Objective

Evaluation of 4 different dose regimens of dabigatran compared to placebo regarding efficacy and safety in patients with ACS on dual antiplatelet therapy

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Trial design

Randomized, double-blind phase II study, dose-escalation trial
Active treatment: dabigatran 50 mg (n=369), 75 mg (n=368), 110 mg (n=406) or 150 mg (n=347) p.o. twice daily, for 6 months
Control treatment: placebo for 6 months (n=371)

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Endpoints

Primary endpoint: major or clinically relevant non-major bleeding events
Secondary endpoints: clinical chemistry levels of coagulation activity, composite of cardiovascular death, non-fatal myocardial infarction and nonhemorrhagic stroke

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Trial participants

1861 patients (mean age 61 years), hospitalized with non-ST (40%) or STsegment (60%) elevation myocardial infarction within the last 14 days and ≥1 risk factor for cardiovascular complications, receiving dual antiplatelet treatment (ASA and clopidogrel or another thienopyridine)

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Results

Primary outcome: The primary endpoint (major or clinically relevant nonmajor bleeding events) occurred in 27 of 347 patients (7.8%) given 150 mg dabigatran twice daily, in 32 of 406 patients (7.9%) given 110 mg dabigatran twice daily, in 16 of 368 patients (4.3%) given 75 mg dabigatran twice daily, in 13 of 369 patients (3.5%) given 50 mg dabigatran twice daily, and in 8 of 371 patients (2.2%) given placebo during the study period
Secondary outcomes: D-Dimer-levels in patients were significantly lower during treatment with dabigatran when compared to placebo. In patients treated with higher doses of dabigatran the rate of the combined efficacy endpoint of cardiovascular death, non-fatal myocardial infarction and non-hemorrhagic stroke was lower (110 mg: 3.0%; 150 mg: 3.5%) than in patients with lower doses of dabigatran (50 mg: 4.6%; 75 mg: 4.9%)

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Summary

Efficacy: There were higher rates of cardiovascular death, non-fatal myocardial infarction or non-hemorrhagic stroke in lower doses of dabigatran when compared to higher doses
Safety: Addition of dabigatran in patients on dual antiplatelet therapy was associated with a dose-dependent increase of major or clinicially relevant minor bleedings

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Reference

Oldgren J, Budaj A, Granger C, Khder Y, Roberts J, Siegbahn A, Tijssen J G P, Van de Werf F, Wallentin L, for the RE-DEEM Investigators. Dabigatran vs. placebo in patients with acute coronary syndromes on dual antiplatelet therapy: a randomized, double-blind, phase II trial. Eur Heart J 2011, May 7, epub ahead of print

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Corresponding author

Jonas Oldgren, Uppsala Clinical Research Center and Department of Medical Sciences, Uppsala University, S-751 85 Uppsala, Sweden
e-mail: jonas.oldgren@ucr.uu.se

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