The RELY-ABLE study comprised of:

  • The long-term, multi-center extension of dabigatran treatment in patients with atrial fibrillation (AF) who completed the RE-LY trial
  • A cluster randomised trial to assess the effect of a knowledge translation intervention on patient outcomes

The objective of the RELY-ABLE study was 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 AF.

Since the objective of this trial was safety, there were 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 were adjudicated.

Study Type

Interventional - Drug

Study Design

Treatment, parallel group design, safety study.

NO. of Countries


NO. of Sites


NO. of Participants


Study Period

2008 - 2013



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