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, Jeffrey I. Weitz

*Corresponding author for this work

Research output: Contribution to journalArticlepeer-review

123 Scopus citations

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).

Original languageEnglish (US)
Pages (from-to)198-205
Number of pages8
JournalThrombosis and Haemostasis
Volume114
Issue number1
DOIs
StatePublished - Jan 1 2015

ASJC Scopus subject areas

  • Hematology

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