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Research

Photo for RELY - ABLE

RELY - ABLE

Official Title

RELY-ABLE Long Term Multi-Center Extension of Dabigatran Treatment in Patients With Atrial Fibrillation Who Completed the RE-LY Trial and a Cluster Randomised Trial to Assess the Effect of a Knowledge Translation Intervention on Patient Outcomes

Status

Completed

Overview

To establish the long term safety of dabigatran etexilate and to assess the efficacy of a knowledge translation intervention on the prognosis, cardiovascular risk profile and quality of care in patients with atrial fibrillation (AF).

Study Design

Treatment, parallel group design, safety study.

Primary Endpoint

Since the objective of this trial is safety, there are no primary efficacy endpoints. Safety will primarily be determined by the occurrence of major bleeding. Secondary Endpoint: Individual and composite incidence of stroke, non CNS systemic embolism, pulmonary embolism, acute myocardial infarction, deep vein thrombosis and all deaths. Outcome events are adjudicated.

Number of Patients

5851

Number of Sites

598

Number of Countries

35

Study Period

2008–2013

Principal Investigator

Stuart Connolly

Program Manager

Ellison Themeles

Research Coordinator

Suzanne Bajkor, Alex Grinvalds, Kim Simek

Collaborators

Boehringer-Ingelheim

Key Publications

  • Stuart J. Connolly, Lars Wallentin, Michael D. Ezekowitz, John Eikelboom, Jonas Oldgren, Paul A. Reilly, Martina Brueckmann, Janice Pogue, Marco Alings, John V. Amerena, Alvaro Avezum, Iris Baumgartner, Andrzej J. Budaj, Jyh-Hong Chen, Antonio L. Dans, Harald Darius, Giuseppe Di Pasquale, Jorge Ferreira, Greg C. Flaker, Marcus D. Flather, Maria Grazia Franzosi, Sergey P. Golitsyn, David A. Halon, Hein Heidbuchel, Stefan H. Hohnloser, Kurt Huber, Petr Jansky, Gabriel Kamensky, Matyas Keltai, Sung Soon Kim, Chu-Pak Lau, Jean-Yves Le Heuzey, Basil S. Lewis, Lisheng Liu, John Nanas, Razali Omar, Prem Pais, Knud E. Pedersen, Leopoldo S. Piegas, Dimitar Raev, Pal J. Smith, Mario Talajic, Ru San Tan, Supachai Tanomsup, Lauri Toivonen, Dragos Vinereanu, Denis Xavier, Jun Zhu, Susan Q. Wang, Christine O. Duffy, Ellison Themeles and Salim Yusuf. The Long-Term Multicenter Observational Study of Dabigatran Treatment in Patients With Atrial Fibrillation (RELY-ABLE) Study. Circulation 2013; 128: 237-243. (Originally published online June 14, 2013