Reduced-dosed Rivaroxaban and Standard-dosed Rivaroxaban Versus ASA in the Long-term Prevention of Recurrent Symptomatic Venous Thromboembolism in Patients With Symptomatic Deep-vein Thrombosis and/or Pulmonary Embolism

Trial Profile

Reduced-dosed Rivaroxaban and Standard-dosed Rivaroxaban Versus ASA in the Long-term Prevention of Recurrent Symptomatic Venous Thromboembolism in Patients With Symptomatic Deep-vein Thrombosis and/or Pulmonary Embolism

Completed
Phase of Trial: Phase III

Latest Information Update: 28 Jun 2017

At a glance

  • Drugs Rivaroxaban (Primary) ; Aspirin
  • Indications Deep vein thrombosis; Pulmonary embolism; Venous thromboembolism; Venous thrombosis
  • Focus Adverse reactions; Registrational; Therapeutic Use
  • Acronyms EINSTEIN-CHOICE
  • Sponsors Bayer
  • Most Recent Events

    • 28 Jun 2017 According to a Janssen media release, the U.S. Food and Drug Administration (FDA) accepted for Priority Review a supplemental New Drug Application (sNDA) for XARELTO (rivaroxaban) to include a 10 mg once-daily dose for reducing the risk of VTE after at least six months of standard anticoagulant therapy. Data from this study supported the application. The FDA's Prescription Drug User Fee Act (PDUFA) target date is October 28, 2017.
    • 28 Apr 2017 According to a Janssen Research & Development media release, baesd on data from this trial, company has submitted a supplemental New Drug Application (sNDA) to the U.S. Food and Drug Administration (FDA) to update the prescribing information for XARELTO (rivaroxaban) to add a 10 mg dose to reduce patients risk of recurrent venous thromboembolism (VTE) after at least six months of standard anticoagulation therapy.
    • 18 Mar 2017 Results published in the New England Journal of Medicine
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