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

Published

Journal Article

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).

Full Text

Duke Authors

Cited Authors

  • Pollack, CV; Reilly, PA; Bernstein, R; Dubiel, R; Eikelboom, J; Glund, S; Huisman, MV; Hylek, E; Kam, C-W; Kamphuisen, PW; Kreuzer, J; Levy, JH; Sellke, F; Stangier, J; Steiner, T; Wang, B; Weitz, JI

Published Date

  • July 2015

Published In

Volume / Issue

  • 114 / 1

Start / End Page

  • 198 - 205

PubMed ID

  • 26020620

Pubmed Central ID

  • 26020620

Electronic International Standard Serial Number (EISSN)

  • 2567-689X

International Standard Serial Number (ISSN)

  • 0340-6245

Digital Object Identifier (DOI)

  • 10.1160/th15-03-0192

Language

  • eng