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A Phase III Case Series Clinical Study of the Reversal of the Anticoagulant Effects of Dabigatran by Intravenous Administration of 5.0g Idarucizumab (BI 655075) in Patients Treated With Dabigatran Etexilate Who Have Uncontrolled Bleeding or Require Emergency Surgery or Procedures.RE-VERSE AD (A Study of the RE-VERSal Effects of Idarucizumab on Active Dabigatran) Trial

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Trial Profile

A Phase III Case Series Clinical Study of the Reversal of the Anticoagulant Effects of Dabigatran by Intravenous Administration of 5.0g Idarucizumab (BI 655075) in Patients Treated With Dabigatran Etexilate Who Have Uncontrolled Bleeding or Require Emergency Surgery or Procedures.RE-VERSE AD (A Study of the RE-VERSal Effects of Idarucizumab on Active Dabigatran) Trial

Status: Completed
Phase of Trial: Phase III

Latest Information Update: 30 Jun 2022

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At a glance

  • Drugs Idarucizumab (Primary)
  • Indications Blood coagulation disorders
  • Focus Registrational; Therapeutic Use
  • Acronyms RE-VERSE AD
  • Sponsors Boehringer Ingelheim; Boehringer Ingelheim Pharma KG; Nippon Boehringer Ingelheim

    • Most Recent Events

    • 01 Sep 2021 Results of sub-analysis assessing anticoagulation reversal and clinical outcomes in dabigatran treated patients requiring urgent surgery or procedural intervention published in the Annals of Surgery
    • 08 Oct 2019 Results assessing the extent of reversal and outcomes according to baseline renal function in dabigatran-treated nondialysis patients receiving idarucizumab, published in the Journal of the American College of Cardiology
    • 03 May 2019 Results analysing the pharmacokinetics of idarucizumab and its target dabigatran in bleeding/surgical patients published in the Journal of Thrombosis and Haemostasis
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