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Design and rationale for RE-VERSE AD: A phase 3 study of idarucizumab, a specific reversal agent for dabigatran
Charles V Pollack1, Paul A Reilly, Richard Bernstein
1Charles 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,
Abstract:
Idarucizumab, 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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