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Oral Direct Factor Xa Inhibitor Rivaroxaban in Patients With Acute Symptomatic Deep-Vein Thrombosis or Pulmonary Embolism

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Trial Profile

Oral Direct Factor Xa Inhibitor Rivaroxaban in Patients With Acute Symptomatic Deep-Vein Thrombosis or Pulmonary Embolism

Status: Completed
Phase of Trial: Phase III

Latest Information Update: 28 Dec 2021

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At a glance

  • Drugs Rivaroxaban (Primary) ; Acenocoumarol; Enoxaparin sodium; Warfarin
  • Indications Deep vein thrombosis; Pulmonary embolism
  • Focus Registrational; Therapeutic Use
  • Acronyms EINSTEIN-DVT
  • Sponsors Bayer; Bayer HealthCare; Janssen Research & Development

Most Recent Events

  • 22 Dec 2021 According to a Bayer media release, based on data from EINSTEIN DVT, PE and EXTENSION, EINSTEIN-Jr., and UNIVERSE, the U.S. FDA has approved two pediatric indications for Xarelto: the treatment of VTE and reduction in the risk of recurrent VTE in patients from birth to less than 18 years after at least five days of initial parenteral anticoagulant treatment; and thromboprophylaxis in children aged two years and older with congenital heart disease who have undergone the Fontan procedure.
  • 12 Jul 2019 This trial has been completed in Spain, according to European Clinical Trials Database.
  • 23 May 2018 Results assessing costs and quality-adjusted life years of DVT patients treated with rivaroxaban or enoxaparin/warfarin in China, presented at the 23rd Annual International Meeting of the International Society for Pharmacoeconomics and Outcomes Research

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