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Rationale, design, and protocol of a randomized controlled trial of the safety and efficacy of dabigatran etexilate versus dose-adjusted warfarin in patients with cerebral venous thrombosis.

Abstract
Rationale To prevent recurrent venous thrombotic events after acute cerebral venous or dural sinus thrombosis, guidelines recommend long-term oral anticoagulation with vitamin K antagonists. Non-vitamin K oral anticoagulant experience in cerebral venous or dural sinus thrombosis is limited to case reports and series. Aim To compare dabigatran with dose-adjusted warfarin in patients with cerebral venous or dural sinus thrombosis for the prevention of recurrent venous thrombotic event. Sample size One hundred and twenty patients. Methods and design This study is a phase III, prospective, randomized, parallel-group, open-label, multicenter, exploratory trial with blinded endpoint adjudication. Patients with acute cerebral venous or dural sinus thrombosis after 5-15 days of treatment with parenteral heparin are randomized to either dabigatran etexilate 150 mg twice daily or dose-adjusted (international normalized ratio 2-3) warfarin (≤24 weeks). Study outcome The primary endpoint is a composite of patients with new venous thrombotic event (recurring cerebral venous or dural sinus thrombosis, deep venous thrombosis of any limb, pulmonary embolism, and major bleeding (International Society on Thrombosis and Hemostasis definition)) during the treatment period. Statistics will be descriptive (number and frequencies). Study timelines Inclusion started in December 2016. Final results are expected by the end of 2018. Discussion This exploratory trial is the first to compare vitamin K with non-vitamin K antagonists in cerebral venous or dural sinus thrombosis. It will provide evidence to guide physicians and patients in choosing oral anticoagulants to prevent venous thrombotic event after acute cerebral venous or dural sinus thrombosis. ClinicalTrials.gov number: NCT02913326.
AuthorsJosé M Ferro, Francesco Dentali, Jonathan M Coutinho, Adam Kobayashi, Jorge Caria, Marc Desch, Mandy Fraessdorf, Holger Huisman, Hans-Christoph Diener
JournalInternational journal of stroke : official journal of the International Stroke Society (Int J Stroke) Vol. 13 Issue 7 Pg. 766-770 (10 2018) ISSN: 1747-4949 [Electronic] United States
PMID29775170 (Publication Type: Clinical Trial Protocol, Comparative Study, Journal Article, Research Support, N.I.H., Extramural, Research Support, Non-U.S. Gov't)
Chemical References
  • Anticoagulants
  • Warfarin
  • Dabigatran
Topics
  • Adult
  • Aged
  • Anticoagulants (adverse effects, therapeutic use)
  • Cerebral Veins
  • Clinical Trials, Phase III as Topic (methods)
  • Dabigatran (adverse effects, therapeutic use)
  • Dura Mater (blood supply)
  • Female
  • Humans
  • Male
  • Middle Aged
  • Multicenter Studies as Topic (methods)
  • Randomized Controlled Trials as Topic (methods)
  • Venous Thrombosis (drug therapy)
  • Warfarin (adverse effects, therapeutic use)
  • Young Adult

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