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Center for Global Research Data

The clinical impact of dabigratran in patients with non-valvular atrial fibrillation who had a fall or head injury: a retrospective analysis of RE-LY

Lead Investigator: Daniel Caldeira, University of Lisbon/CCUL
Title of Proposal Research: The clinical impact of dabigratran in patients with non-valvular atrial fibrillation who had a fall or head injury: a retrospective analysis of RE-LY
Vivli Data Request: 5294
Funding Source: None.
Potential Conflicts of Interest: Participated in educational meetings and/or attended a conferences or symposia (including travel, accommodation and/or hospitality) with Bristol-Myers Squibb, Bayer, Boehringer Ingelheim, Daiichi Sankyo, Merck Serono, Ferrer, Pfizer, Novartis and Roche.

Summary of the Proposed Research:

Atrial fibrillation is the most prevalent persistent arrhythmia and it is estimated that this condition is present in 33.5 million individuals worldwide. In this arrhythmia, some of heart chamber lose the contractility (atrial chambers) which leads to an increased risk of clot formation and migration to other places, such as the brain leading to stroke. Anticoagulants are essential to prevent clot formation and stroke in patients with atrial fibrillation. All these drugs increase the risk of bleeding and one of the barriers to prescribe these drugs was the risk of bleeding in the cranius. To overcome these hypothetical barriers, some studies claimed that it would be needed 295 falls to have 1 intracranial hemorrhage. Recently, novel anticoagulants showed to have a better safety profile than the older anticoagulants (warfarin) which includes a lower risk of intracranial hemorrhage. Dabigatran is one of these novel drugs but it is not known whether it improve In this study we aim to evaluate the outcomes of patients with atrial fibrillation (AF) that had a fall or head injury, assessing the data reported in the clinical trial RE-LY to evaluate whether dabigatran treatment leads to lower risk of complications in this setting. Briefly, we will explore the potential protective role of dabigatran in traumatic events.

Requested Studies:

Randomized Evaluation of Long Term Anticoagulant Therapy (RE-LY) Comparing the Efficacy and Safety of Two Blinded Doses of Dabigatran Etexilate With Open Label Warfarin for the Prevention of Stroke and Systemic Embolism in Patients With Non-valvular Atrial Fibrillation: Prospective, Multi-centre, Parallel-group, Non-inferiority Trial (RE-LY Study)
Sponsor: Boehringer Ingelheim
Study ID: NCT00262600
Sponsor ID: 1160.26