Dabigatran is an oral thrombin inhibitor that is indicated in Canada for the prevention of venous thromboembolism in patients who have undergone hip or knee replacement. In the RE-LY study (Randomized Evaluation of Long-term anticoagulant therapY), a 2-year multicentre non-inferiority trial, patients with atrial fibrillation who had an increased risk of stroke were randomly assigned (by allocation concealment) to receive dabigatran 110 mg twice daily or 150 mg twice daily (blinded) or warfarin (open-label). Concomitant use of acetylsalicylic acid (ASA, less than 100 mg/day) and amiodarone was allowed. In addition, use of quinidine was permitted until 2 years after the trial started; at that point, the protocol was amended to limit use of this drug because of its ability to increase plasma concentrations of dabigatran.
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