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Winthrop University Hospital

RELY-ABLE Long term multi-center extension of dabigatran treatment in patients with atrial fibrillation

Summary

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 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).

Description

The RELY-ABLE trial will provide an opportunity for patients maintained on dabigatran for 12-36 months in RE-LY to receive continued treatment after the closure of RE-LY. RELY-ABLE will provide additional, safety information on patients with long-term exposure to dabigatran. Most patients that are diagnosed with AF tend to remain on oral anticoagulation for the remainder of their lives providing anticoagulation does not become contraindicated. The continuing exposure of patients to dabigatran etexilate will provide an extended safety profile of the 110 mg b.i.d. and 150 mg b.i.d. doses. This extension of RE-LY trial plans for a total number of approximately 8,000 patients to be enrolled with half entered into each treatment arm( 1. dabigatran etexilate 110 mg b.i.d. (two times daily): N=~4,000 2. dabigatran etexilate 150 mg b.i.d.: N=~4,000)

Inclusion/exclusion

Inclusion Criteria: 1) Randomization to dabigatran etexilate in RE-LY (1160.26) and no premature discontinuation of therapy 2) Investigator determines it is clinically appropriate for patient to continue receiving long-term treatment with oral anticoagulation

Principal Investigator

Joseph Germano,D.O.

Department

Division of Cardiology

Email

jgermano@winthrop.org
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