Efficacy and safety of RivaroXaban and DAbigatran versus AcenocouMarol in Cerebral Venous Thrombosis
- Conditions
- Nervous System Diseases
- Registration Number
- PACTR202202477162480
- Lead Sponsor
- Hasan II University Hospital of Fez
- Brief Summary
Not available
- Detailed Description
Not available
Recruitment & Eligibility
- Status
- Recruiting
- Sex
- All
- Target Recruitment
- 60
1. Informed consent written in accordance with the rules of good clinical practice and laws in force in the country.
2. Confirmed diagnosis of venous or cerebral thrombosis (DVT), with or without intracranial hemorrhage (CT scan injected or brain MRI)
3. Curative dose anticoagulant (LMWH) therapy that has been administered from confirmation of diagnosis to randomization;
4. Eligibility for oral anticoagulant therapy.
1. Cerebral venous thrombosis (CVT) associated with central nervous system infection or head trauma.
2. Medical or surgical conditions associated with an increased risk of bleeding
3. History of symptomatic nontraumatic intracranial hemorrhage at high risk of recurrence
4. Treatment with an antithrombotic regimen for an indication other than CVT and requiring continuation of this treatment for the initial diagnosis without modification of the treatment regimen
5. Severe renal insufficiency
6. Active hepatopathy
7. Pregnancy ongoing or planned during the clinical trial
8. Any contraindications to VKA or NOAC.
Study & Design
- Study Type
- Interventional
- Study Design
- Not specified
- Primary Outcome Measures
Name Time Method Mortality (any cause) in the year following randomization, major bleeding or new venous thrombotic event (VTE)
- Secondary Outcome Measures
Name Time Method Cerebral venous recanalization measured by change in the number of occluded cerebral veins and dural sinuses after 24 week.<br>;Number of patients with clinically significant non-major bleeding events after 24 weeks