• Thromb. Haemost. · Jul 2015

    Multicenter Study Observational Study

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

    • Charles V Pollack, Paul A Reilly, Richard Bernstein, Robert Dubiel, John Eikelboom, Stephan Glund, Menno V Huisman, Elaine Hylek, Chak-Wah Kam, Pieter W Kamphuisen, Joerg Kreuzer, Jerrold H Levy, Frank Sellke, Joachim Stangier, Thorsten Steiner, Bushi Wang, and Jeffrey I Weitz.
    • Charles V. Pollack Jr., Department of Emergency Medicine, Pennsylvania Hospital, University of Pennsylvania Health System, 800 Spruce St, Philadelphia, PA 19107, USA, Tel.: +1 215 8297549, Fax: +1 215 8298044, E-mail: cvpollack@gmail.com.
    • Thromb. Haemost. 2015 Jul 1; 114 (1): 198-205.

    AbstractIdarucizumab, 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 REVERSal Effects of Idarucizumab in Patients on Active Dabigatran (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).

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