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.