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Editor's Note
April 22, 2020

High Rates of Off-label Prescribing and the Urgent Need for a Randomized Clinical Trial

Author Affiliations
  • 1Duke Clinical Research Institute, Durham, North Carolina
  • 2Associate Editor, JAMA Cardiology
  • 3Icahn School of Medicine at Mount Sinai, New York, New York
JAMA Cardiol. 2020;5(6):692-693. doi:10.1001/jamacardio.2020.0612

Direct oral anticoagulants (DOACs) have been a breakthrough therapy for adults with nonvalvular atrial fibrillation and venous thromboembolic disease, disease states for which these drugs have been approved by the US Food and Drug Administration. However, these therapies are not a panacea. Most notably, warfarin remains the standard of care for those with mechanical valves. The Randomised, Phase II Study to Evaluate the Safety and Pharmacokinetics of Oral Dabigatran Etexilate in Patients After Heart Valve Replacement (RE-ALIGN) trial, a phase 2 study of dabigatran vs warfarin, was stopped early because of excess thromboembolic and bleeding events in those receiving dabigatran compared with those receiving warfarin.1