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Int J Stroke. 2018 Oct;13(7):766-770. doi: 10.1177/1747493018778125. Epub 2018 May 18.

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.

Author information

1
1 Department of Neurosciences and Mental Health, Hospital Santa Maria, University of Lisbon, Lisbon, Portugal.
2
2 Department of Clinical and Experimental Medicine, Insubria University, Varese, Italy.
3
3 Department of Neurology, Academic Medical Centre, Amsterdam, the Netherlands.
4
4 Interventional Stroke and Cerebrovascular Disease Treatment Center and Department of Neuroradiology, Institute of Psychiatry and Neurology, Warsaw, Poland.
5
5 Boehringer Ingelheim GmbH & Co. KG, Ingelheim am Rhein, Germany.
6
6 Boehringer Ingelheim B.V., Alkmaar, the Netherlands.
7
7 Department of Neurology and Stroke Center, University Hospital Essen, Essen, Germany.

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.

KEYWORDS:

Cerebrovascular thrombosis; dabigatran; efficacy and safety; oral anticoagulants; venous thrombotic events; warfarin

PMID:
29775170
DOI:
10.1177/1747493018778125
[Indexed for MEDLINE]

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