Design and rationale for RE-VERSE AD: A phase 3 study of idarucizumab, a specific reversal agent for dabigatran Journal Articles uri icon

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abstract

  • SummaryIdarucizumab, a Fab fragment directed against dabigatran, produced rapid and complete reversal of the anticoagulation effect of dabigatran in animals and in healthy volunteers. The Study of the REVERS al E ffects of Idarucizumab in Patients on A ctive D abigatran (RE-VERSE AD™) is a global phase 3 prospective cohort study aimed at investigating idarucizumab in dabigatran-treated patients who present with uncontrollable or life-threatening bleeding, and in those requiring urgent surgery or intervention. We describe the rationale for, and design of the trial (clinicaltrials.gov NCT02104947).

authors

  • Reilly, Paul A
  • Bernstein, Richard
  • Dubiel, Robert
  • Eikelboom, John
  • Glund, Stephan
  • Huisman, Menno V
  • Hylek, Elaine
  • Kam, Chak-Wah
  • Kamphuisen, Pieter W
  • Kreuzer, Joerg
  • Levy, Jerrold H
  • Sellke, Frank
  • Stangier, Joachim
  • Steiner, Thorsten
  • Wang, Bushi
  • Weitz, Jeffrey
  • Pollack, Charles V

publication date

  • 2015