Cerebral Venous Thrombosis
Conditions
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.
Interventions
DRUGDabigatran etexilate
Subjects should take Dabigatran etexilate 150mg twice a day for 6 months after randomization.
DRUGWarfarin
Subjects should take Warfarin for 6 months after randomization and the dose will be changed according to investigator's judgment.
Sponsors
Capital Medical University
Study design
Allocation
RANDOMIZED
Intervention model
PARALLEL
Primary purpose
TREATMENT
Masking
SINGLE (Outcomes Assessor)
Eligibility
Sex/Gender
ALL
Age
18 Years to 80 Years
Healthy volunteers
No
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.
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| The incidence of recanalized cerebral veins after 6 months | 0-6 months after randomization | cerebral venous recanalisation rate after anticoagulation treatment for 6 months. |
Secondary
| Measure | Time frame | Description |
|---|---|---|
| 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 | 0-6 months after randomization | Number of subjects with major bleeding events according to International Society on Thrombosis and Haemostasis criteria within 6 months. |
| Number of subjects with venous thrombosis events | 0-6 months after randomization | 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. |
| 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 | — |
| Number of subjects with clinically relevant non-major bleeding events | 0-6 months after randomization | Number of subjects with clinically relevant non-major bleeding events according to International Society on Thrombosis and Haemostasis criteria within 6 months. |
Countries
China
Contacts
Primary ContactXunming Ji
Backup ContactTingting Bian
Outcome results
None listed