Thromb Haemost 2015; 114(01): 198-205
DOI: 10.1160/TH15-03-0192
Trial Protocol Design Paper
Schattauer GmbH

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

Authors

  • Charles V. Pollack Jr.

    1   Pennsylvania Hospital, Philadelphia, Pennsylvania, USA
  • Paul A. Reilly

    2   Boehringer Ingelheim Pharmaceuticals, Ridgefield, Conneticut, USA
  • Richard Bernstein

    3   Northwestern University, Chicago, Illinois, USA
  • Robert Dubiel

    2   Boehringer Ingelheim Pharmaceuticals, Ridgefield, Conneticut, USA
  • John Eikelboom

    4   McMaster University, Hamilton, Ontario, Canada
  • Stephan Glund

    5   Boehringer Ingelheim Pharma GmbH & Co. KG, Biberach, Germany
  • Menno V. Huisman

    6   Leiden University Medical Center, Leiden, Netherlands
  • Elaine Hylek

    7   Boston University School of Medicine, Boston, Massachusetts, USA
  • Chak-Wah Kam

    8   Tuen Mun Hospital, Tuen Mun, NT, Hong Kong
  • Pieter W. Kamphuisen

    9   University Medical Center, Groningen, Netherlands
  • Joerg Kreuzer

    10   Boehringer Ingelheim Pharma GmbH & Co. KG, Ingelheim, Germany
  • Jerrold H. Levy

    11   Duke University Medical Center, Durham, North Carolina, USA
  • Frank Sellke

    12   Brown Medical School, Providence, Rhode Island, USA
  • Joachim Stangier

    5   Boehringer Ingelheim Pharma GmbH & Co. KG, Biberach, Germany
  • Thorsten Steiner

    13   University of Heidelberg, Heidelberg, Germany
  • Bushi Wang

    2   Boehringer Ingelheim Pharmaceuticals, Ridgefield, Conneticut, USA
  • Jeffrey I. Weitz

    4   McMaster University, Hamilton, Ontario, Canada
Further Information

Publication History

Received: 03 March 2015

Accepted after major revision: 19 May 2015

Publication Date:
22 November 2017 (online)

Preview

Summary

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 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).