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Oral direct factor Xa inhibitor rivaroxaban in patients with acute symptomatic pulmonary embolism - The EINSTEIN PE Study

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Trial Profile

Oral direct factor Xa inhibitor rivaroxaban in patients with acute symptomatic pulmonary embolism - The EINSTEIN PE Study

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; Venous thromboembolism
  • Focus Registrational; Therapeutic Use
  • Acronyms EINSTEIN-PE
  • 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.
    • 08 Apr 2021 Results (n=371) of a substudy of the Einstein-PE study assessing Sex-specific differences in clot resolution 3 weeks after acute pulmonary embolism managed with anticoagulants, published in the Journal of Thrombosis and Haemostasis
    • 12 Jul 2019 This trial has been completed in France, according to European Clinical Trials Database.

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