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

Study Overview
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Brief Summary
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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.

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

Conditions
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Cerebral Venous Thrombosis

Intervention / Treatment
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* Drug: Dabigatran etexilate
* Drug: Warfarin


Participation Criteria
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Eligibility Criteria
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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.

Ages Eligible for Study
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Minimum Age: 18 Years
Maximum Age: 80 Years

Sexes Eligible for Study
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All

Accepts Healthy Volunteers
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No

Study Plan
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How is the study designed?
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Design Details

Primary Purpose: Treatment
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Single


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Experimental: Dabigatran etexilate group<br>Subjects in this group will take Dabigatran etexilate for 6 months after randomization | Drug: Dabigatran etexilate<br>* Subjects should take Dabigatran etexilate 150mg twice a day for 6 months after randomization.<br>|
| Active Comparator: Warfarin group<br>Subjects in this group will take Warfarin for 6 months after randomization | Drug: Warfarin<br>* Subjects should take Warfarin for 6 months after randomization and the dose will be changed according to investigator's judgment.<br>|

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| The incidence of recanalized cerebral veins after 6 months | cerebral venous recanalisation rate after anticoagulation treatment for 6 months. | 0-6 months after randomization | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Number of subjects with venous thrombosis events | Number of subjects with recurrent cerebral venous and dural sinus thrombosis, deep venous thrombosis of any limb, pulmonary embolism or splanchnic vein thrombosis within 6 months. | 0-6 months after randomization | 
| The change of optic disc edema grade and lumbar puncture pressure after 6 months |  | 0-6 months after randomization | 
| Number of subjects with major bleeding events | Number of subjects with major bleeding events according to International Society on Thrombosis and Haemostasis criteria within 6 months. | 0-6 months after randomization | 
| Number of subjects with clinically relevant non-major bleeding events | Number of subjects with clinically relevant non-major bleeding events according to International Society on Thrombosis and Haemostasis criteria within 6 months. | 0-6 months after randomization | 
| Number of subjects with new intracranial haemorrhage or worsening of the previous intracranial haemorrhage |  | 0-6 months after randomization | 
| Number of subjects with any bleeding events within 6 months |  | 0-6 months after randomization |