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Randomised controlled trial
For people with non-valvular atrial fibrillation rivaroxaban is non-inferior to warfarin for preventing stroke or embolism, with no difference in the risk of clinically relevant bleeding
  1. Matthew Sherwood,
  2. Jonathan P Piccini
  1. Duke Clinical Research Institute, Duke University Medical Center, Durham, North Carolina, USA
  1. Correspondence to Matthew Sherwood
    Duke Clinical Research Institute, Duke University Medical Center, PO Box 17969, Durham, NC 27710, USA; matthew.sherwood{at}duke.edu

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Context

Atrial fibrillation (AF) significantly increases the risk of thromboembolism. Until recently, thromboprophylaxis in high-risk AF patients has been limited to vitamin K antagonists. Emerging, novel oral anticoagulants are more selective, targeting specific steps in the coagulation cascade. These agents include direct thrombin inhibitors such as dabigatran and Factor Xa inhibitors such as rivaroxaban, and apixaban. These medications bring the potential for decreased monitoring and improved risk profiles with regard to bleeding and drug-drug interactions.

Methods

Rivaroxaban Once Daily Oral Direct Factor Xa Inhibition Compared with Vitamin K Antagonism for Prevention of Stroke and Embolism Trial in Atrial Fibrillation (ROCKET AF) was an international, multicentre, event-driven non-inferiority trial comparing rivaroxaban versus dose-adjusted warfarin for the prevention of stroke and systemic embolism (primary efficacy endpoint). ROCKET AF enrolled 14264 patients with non-valvular AF at moderate to high risk of stroke and randomised them in …

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