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

Charles V. Pollack Jr.; 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

doi:10.1160/TH15-03-0192

Thrombosis and Haemostasis, Table of Contents

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

Charles V. Pollack Jr.

¹Pennsylvania Hospital, Philadelphia, Pennsylvania, USA

,

Paul A. Reilly

²Boehringer Ingelheim Pharmaceuticals, Ridgefield, Conneticut, USA

,

Richard Bernstein

³Northwestern University, Chicago, Illinois, USA

,

Robert Dubiel

²Boehringer Ingelheim Pharmaceuticals, Ridgefield, Conneticut, USA

,

John Eikelboom

⁴McMaster University, Hamilton, Ontario, Canada

,

Stephan Glund

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

,

Menno V. Huisman

⁶Leiden University Medical Center, Leiden, Netherlands

,

Elaine Hylek

⁷Boston University School of Medicine, Boston, Massachusetts, USA

,

Chak-Wah Kam

⁸Tuen Mun Hospital, Tuen Mun, NT, Hong Kong

,

Pieter W. Kamphuisen

⁹University Medical Center, Groningen, Netherlands

,

Joerg Kreuzer

¹⁰Boehringer Ingelheim Pharma GmbH & Co. KG, Ingelheim, Germany

,

Jerrold H. Levy

¹¹Duke University Medical Center, Durham, North Carolina, USA

,

Frank Sellke

¹²Brown Medical School, Providence, Rhode Island, USA

,

Joachim Stangier

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

,

Thorsten Steiner

¹³University of Heidelberg, Heidelberg, Germany

,

Bushi Wang

²Boehringer Ingelheim Pharmaceuticals, Ridgefield, Conneticut, USA

,

Jeffrey I. Weitz

⁴McMaster University, Hamilton, Ontario, Canada

› Author Affiliations

Abstract

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).

Full Text

References

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