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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.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| Dabigatran etexilate group | Experimental | Subjects in this group will take Dabigatran etexilate for 6 months after randomization |
|
| Warfarin group | Active Comparator | Subjects in this group will take Warfarin for 6 months after randomization |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| Dabigatran etexilate | Drug | Subjects should take Dabigatran etexilate 150mg twice a day for 6 months after randomization. |
|
| 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 |
| 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 |
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Inclusion Criteria:
Exclusion Criteria:
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| Name | Role | Phone | Extension | |
|---|---|---|---|---|
| Xunming Ji | Contact | +86-83198952 | jixunming@vip.163.com | |
| Tingting Bian | Contact | biantingting062350@163.com |
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| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| Xuanwu Hospital Capital Medical University | Recruiting | Beijing | China |
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| ID | Term |
|---|---|
| D020767 | Intracranial Thrombosis |
| ID | Term |
|---|---|
| D002542 | Intracranial Embolism and Thrombosis |
| D002561 | Cerebrovascular Disorders |
| D001927 | Brain Diseases |
| D002493 | Central Nervous System Diseases |
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| ID | Term |
|---|---|
| D000069604 | Dabigatran |
| D014859 | Warfarin |
| ID | Term |
|---|---|
| D011725 | Pyridines |
| D006573 | Heterocyclic Compounds, 1-Ring |
| D006571 | Heterocyclic Compounds |
| D001562 | Benzimidazoles |
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| Warfarin | Drug | Subjects should take Warfarin for 6 months after randomization and the dose will be changed according to investigator's judgment. |
|
| 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 |
| D009422 | Nervous System Diseases |
| D014652 | Vascular Diseases |
| D002318 | Cardiovascular Diseases |
| D013923 | Thromboembolism |
| D016769 | Embolism and Thrombosis |
| D006574 |
| Heterocyclic Compounds, 2-Ring |
| D000072471 | Heterocyclic Compounds, Fused-Ring |
| D015110 | 4-Hydroxycoumarins |
| D003374 | Coumarins |
| D001578 | Benzopyrans |
| D011714 | Pyrans |