Clinical trial NCT03217448: The Efficacy and Safety of Dabigatran Etexilate for the Treatment of Cerebral Venous Thrombosis
Official title: The Efficacy and Safety of Dabigatran Etexilate Comparing With Warfarin for the Anticoagulation Treatment of Cerebral Venous Thrombosis :a Pilot Study
Study type: INTERVENTIONAL
Overall status: UNKNOWN
Phase: PHASE3
Conditions: Cerebral Venous Thrombosis
Lead sponsor: Capital Medical University
Sponsor class: OTHER
First posted: 2017-07-14
Enrollment: 80
Sex: ALL
Minimum age (years): 18
Maximum age (years): 80
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: TREATMENT

Brief summary: 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.


Eligibility criteria: 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.

Primary outcomes:
measure: The incidence of recanalized cerebral veins after 6 months
timeFrame: 0-6 months after randomization
Secondary outcomes:
measure: Number of subjects with venous thrombosis events
timeFrame: 0-6 months after randomization
measure: The change of optic disc edema grade and lumbar puncture pressure after 6 months
timeFrame: 0-6 months after randomization
measure: Number of subjects with major bleeding events
timeFrame: 0-6 months after randomization
measure: Number of subjects with clinically relevant non-major bleeding events
timeFrame: 0-6 months after randomization
measure: Number of subjects with new intracranial haemorrhage or worsening of the previous intracranial haemorrhage
timeFrame: 0-6 months after randomization
measure: Number of subjects with any bleeding events within 6 months
timeFrame: 0-6 months after randomization
Other outcomes:
Locations:
city: Beijing
country: China
facility: Xuanwu Hospital Capital Medical University
Study officials:
References: