The Efficacy and Safety of Dabigatran Etexilate for the Treatment of Cerebral Venous Thrombosis

The Efficacy and Safety of Dabigatran Etexilate Comparing With Warfarin for the Anticoagulation Treatment of Cerebral Venous Thrombosis :a Pilot Study

This is a single-center, prospective, randomized (1:1), open-label study with two parallel groups. This study is planned to investigate the efficacy and safety of dabigatran etexilate comparing with warfarin for the treatment of cerebral venous thrombosis.

Inclusion Criteria:

• Confirmed diagnosis of Cerebral Venous thrombosis (CVT), with or without intracranial haemorrhage.
• Patients in the acute or sub-acute phase of CVT.
• Completion of anticoagulation therapy for 5-15 days which has been administered until randomization; anticoagulation must include full-dose low molecular weight heparin or unfractionated heparin.
• Eligibility for treatment with an oral anticoagulant.
• Written informed consent.

Exclusion Criteria:

• Cerebral Venous thrombosis (CVT) associated with central nervous system infection or due to head trauma.
• Thrombosed venous sinuses showed completely recanalized by MRV before randomisation.
• Planned endovascular treatment for CVT or surgical treatment for other diseases.
• Conditions associated with increased risk of bleeding.
• History of symptomatic non-traumatic intracranial haemorrhage with increased risk of recurrence according to investigator's judgment.
• Treatment with an antithrombotic regimen for an indication other than CVT and requiring continuation of that treatment for the original diagnosis.
• Severe renal impairment(CrCL<30mL/min).
• Active liver disease (ALT≥ twice the upper limit of normal).
• Preganancy, nursing or planning to become pregnant during the trial.