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RECORD 4 Study: REgulation of Coagulation in ORthopedic Surgery to Prevent DVT and PE; a Controlled, Double-Blind, Randomized Study of BAY 59-7939 in the Prevention of VTE in Subjects Undergoing Elective Total Knee Replacement.

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Trial Profile

RECORD 4 Study: REgulation of Coagulation in ORthopedic Surgery to Prevent DVT and PE; a Controlled, Double-Blind, Randomized Study of BAY 59-7939 in the Prevention of VTE in Subjects Undergoing Elective Total Knee Replacement.

Status: Completed
Phase of Trial: Phase III

Latest Information Update: 29 Apr 2021

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At a glance

  • Drugs Rivaroxaban (Primary) ; Enoxaparin sodium
  • Indications Deep vein thrombosis; Pulmonary embolism
  • Focus Registrational; Therapeutic Use
  • Acronyms RECORD-4
  • Sponsors Bayer

Most Recent Events

  • 18 Jan 2016 Retrospective analysis results published in the Annals of Pharmacotherapy
  • 05 Jan 2011 Results from the RECORD trial programme have been included in a complete response filed by Johnson & Johnson with the US FDA, including specific information requested by the FDA, according to a Bayer HealthCare media release.
  • 18 Jul 2009 Results were reported (pooled analysis of RECORD1-4) at the 22nd Congress of the International Society on Thrombosis and Haemostasis.

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