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.
Study Type
INTERVENTIONAL
Allocation
RANDOMIZED
Purpose
TREATMENT
Masking
SINGLE
Enrollment
80
Subjects should take Dabigatran etexilate 150mg twice a day for 6 months after randomization.
Subjects should take Warfarin for 6 months after randomization and the dose will be changed according to investigator's judgment.
Xuanwu Hospital Capital Medical University
Beijing, China
RECRUITINGThe incidence of recanalized cerebral veins after 6 months
cerebral venous recanalisation rate after anticoagulation treatment for 6 months.
Time frame: 0-6 months after randomization
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.
Time frame: 0-6 months after randomization
The change of optic disc edema grade and lumbar puncture pressure after 6 months
Time frame: 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.
Time frame: 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.
Time frame: 0-6 months after randomization
Number of subjects with new intracranial haemorrhage or worsening of the previous intracranial haemorrhage
Time frame: 0-6 months after randomization
Number of subjects with any bleeding events within 6 months
Time frame: 0-6 months after randomization
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