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Dabigatran vs. placebo in patients with acute coronary syndromes on dual antiplatelet therapy: a randomized, double-blind, phase II trial.

Publication ,  Journal Article
Oldgren, J; Budaj, A; Granger, CB; Khder, Y; Roberts, J; Siegbahn, A; Tijssen, JGP; Van de Werf, F; Wallentin, L; RE-DEEM Investigators,
Published in: Eur Heart J
November 2011

AIM: After an acute coronary syndrome, patients remain at risk of recurrent ischaemic events, despite contemporary treatment, including aspirin and clopidogrel. We evaluated the safety and indicators of efficacy of the novel oral direct thrombin inhibitor dabigatran. METHODS AND RESULTS: In this double-blind, placebo-controlled, dose-escalation trial, 1861 patients (99.2% on dual antiplatelet treatment) in 161 centres were enrolled at mean 7.5 days (SD 3.8) after an ST-elevation (60%) or non-ST-elevation (40%) myocardial infarction and randomized to twice daily treatment with dabigatran 50 mg (n = 369), 75 mg (n = 368), 110 mg (n = 406), 150 mg (n = 347), or placebo (n = 371). Primary outcome was the composite of major or clinically relevant minor bleeding during the 6-month treatment period. There were 96 primary outcome events and, compared with placebo, a dose-dependent increase with dabigatran, hazard ratio (HR) 1.77 (95% confidence intervals 0.70, 4.50) for 50 mg; HR 2.17 (0.88, 5.31) for 75 mg; HR 3.92 (1.72, 8.95) for 110 mg; and HR 4.27 (1.86, 9.81) for 150 mg. Compared with placebo, D-dimer concentrations were reduced in all dabigatran dose groups by an average of 37 and 45% at weeks 1 and 4, respectively (P< 0.001). Fourteen (3.8%) patients died, had a myocardial infarction or stroke in the placebo group compared with 17 (4.6%) in 50 mg, 18 (4.9%) in 75 mg, 12 (3.0%) in 110 mg, and 12 (3.5%) in the 150 mg dabigatran groups. CONCLUSIONS: Dabigatran, in addition to dual antiplatelet therapy, was associated with a dose-dependent increase in bleeding events and significantly reduced coagulation activity in patients with a recent myocardial infarction.

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Published In

Eur Heart J

DOI

EISSN

1522-9645

Publication Date

November 2011

Volume

32

Issue

22

Start / End Page

2781 / 2789

Location

England

Related Subject Headings

  • beta-Alanine
  • Treatment Outcome
  • Ticlopidine
  • Recurrence
  • Prospective Studies
  • Platelet Aggregation Inhibitors
  • Myocardial Infarction
  • Middle Aged
  • Male
  • Kaplan-Meier Estimate
 

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Oldgren, J., Budaj, A., Granger, C. B., Khder, Y., Roberts, J., Siegbahn, A., … RE-DEEM Investigators, . (2011). Dabigatran vs. placebo in patients with acute coronary syndromes on dual antiplatelet therapy: a randomized, double-blind, phase II trial. Eur Heart J, 32(22), 2781–2789. https://doi.org/10.1093/eurheartj/ehr113
Oldgren, Jonas, Andrzej Budaj, Christopher B. Granger, Yasser Khder, Juliet Roberts, Agneta Siegbahn, Jan G. P. Tijssen, Frans Van de Werf, Lars Wallentin, and Lars 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 32, no. 22 (November 2011): 2781–89. https://doi.org/10.1093/eurheartj/ehr113.
Oldgren J, Budaj A, Granger CB, Khder Y, Roberts J, Siegbahn A, et al. Dabigatran vs. placebo in patients with acute coronary syndromes on dual antiplatelet therapy: a randomized, double-blind, phase II trial. Eur Heart J. 2011 Nov;32(22):2781–9.
Oldgren, Jonas, et al. “Dabigatran vs. placebo in patients with acute coronary syndromes on dual antiplatelet therapy: a randomized, double-blind, phase II trial.Eur Heart J, vol. 32, no. 22, Nov. 2011, pp. 2781–89. Pubmed, doi:10.1093/eurheartj/ehr113.
Oldgren J, Budaj A, Granger CB, Khder Y, Roberts J, Siegbahn A, Tijssen JGP, Van de Werf F, Wallentin L, 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 Nov;32(22):2781–2789.
Journal cover image

Published In

Eur Heart J

DOI

EISSN

1522-9645

Publication Date

November 2011

Volume

32

Issue

22

Start / End Page

2781 / 2789

Location

England

Related Subject Headings

  • beta-Alanine
  • Treatment Outcome
  • Ticlopidine
  • Recurrence
  • Prospective Studies
  • Platelet Aggregation Inhibitors
  • Myocardial Infarction
  • Middle Aged
  • Male
  • Kaplan-Meier Estimate