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

RationaleTo 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 thrombosisis limited to case reports and series.AimTo compare dabigatranwith dose-adjusted warfarin in patients with cerebral venous or dural sinus thrombosisfor the prevention of recurrent venous thrombotic event.Sample sizeOne hundred and twenty patients.Methods and designThis 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 thrombosisafter 5–15 days of treatment with parenteral heparin are randomized to either dabigatranetexilate 150 mg twice daily or dose-adjusted (international normalized ratio 2–3) warfarin (≤24 weeks).Study outcomeThe primary endpoint is a composite of patients with new ve...