Publication at Second Faculty of Medicine |
2012
Abstract
A randomised, open label, event driven, non-inferiority trial involving 4832 patients with acute symptomatic pulmonary embolism either with or without deep-vein thrombosis compared rivaroxaban (15 mg twice daily for 3 weeks, followed by 20 mg once daily) with standard therapy with enoxaparin followed by an adjusted-dose vitamin K antagonist for 3, 6, or 12 months. The primary efficacy outcome was symptomatic recurrent venous thromboembolism.
The principal safety outcome was major or clinically relevant nonmajor bleeding.