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

International Journal of Stroke : Official Journal of the International Stroke Society
José M FerroHans-Christoph Diener

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)) du...Continue Reading

References

Apr 22, 2005·Journal of Thrombosis and Haemostasis : JTH·S SchulmanUNKNOWN Subcommittee on Control of Anticoagulation of the Scientific and Standardization Committee of the International Society on T
Jun 16, 2010·Circulation·Ida MartinelliPier Mannuccio Mannucci
Jul 17, 2010·Stroke; a Journal of Cerebral Circulation·Bruno MirandaUNKNOWN ISCVT Investigators
Feb 5, 2011·Stroke; a Journal of Cerebral Circulation·Gustavo SaposnikUNKNOWN American Heart Association Stroke Council and the Council on Epidemiology and Prevention
Sep 22, 2012·Stroke; a Journal of Cerebral Circulation·Jonathan M CoutinhoJan Stam
Jul 30, 2014·Stroke; a Journal of Cerebral Circulation·Christina GeisbüschSimon Nagel
Feb 25, 2015·International Journal of Stroke : Official Journal of the International Stroke Society·Marcelo D MendonçaMiguel Viana-Baptista
Sep 4, 2015·Stroke; a Journal of Cerebral Circulation·Rüdiger von KummerWerner Hacke

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Citations

Feb 14, 2019·Der Nervenarzt·Christian WeimarTobias Kurth
May 17, 2019·Stroke; a Journal of Cerebral Circulation·Thalia S Field, Michael D Hill
Jul 17, 2020·Journal of Family Medicine and Primary Care·Subhankar ChatterjeeCarl J Lavie
Aug 24, 2019·Current Neurology and Neuroscience Reports·José M Ferro, Diana Aguiar de Sousa
Sep 18, 2020·Blood Coagulation & Fibrinolysis : an International Journal in Haemostasis and Thrombosis·Sen ShengSanjeeva Onteddu
Mar 17, 2021·International Journal of Stroke : Official Journal of the International Stroke Society·José M FerroUNKNOWN RE-SPECT CVT Study Group
Nov 28, 2018·Thrombosis Research·Fahrettin CovutHamed Daw

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NCT02913326

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