Status:
RECRUITING
Dabigatran Versus Rivaroxaban in Cerebral Venous Thrombosis
Lead Sponsor:
Kafrelsheikh University
Conditions:
Cerebral Venous Sinus Thrombosis
Eligibility:
All Genders
18-75 years
Phase:
PHASE3
Brief Summary
Along with the current clinical trial, the efficacy and safety of a 150 mg Bid dabigatran administered within 24 hours of randomization after having first-ever cerebral venous thrombosis compared to 2...
Detailed Description
The investigators conducted a single-blinded randomized controlled trial between August 2024 and September 2026 after the ethics committee of the faculty of medicine at Kafr el-Sheik University approv...
Eligibility Criteria
Inclusion
- 1-Patients aged 18 and above 2-New diagnosis of symptomatic cerebral venous thrombosis as confirmed on CT/CT venogram or MRI/MR venogram 3-Ability to randomize within 14 days of neuroimaging-confirmed diagnosis 4-The treating clinician thinks that the patient is appropriate for oral anticoagulation as per the standard of care 5-The patient or legally authorized representative can give written informed consent
Exclusion
- The patient has known antiphospholipid antibody syndrome with a previous history of venous or arterial thrombosis
- The patient is anticipated to require invasive procedures (e.g., lumbar puncture, thrombectomy, hemicraniectomy) prior to initiation of oral anticoagulation
- Patient is unable to swallow due to depressed level of consciousness
- Impaired renal function (i.e., CrCl \< 30 mL/min using CockroftGault equation)
- Pregnancy; if a woman is of childbearing potential a urine or serum beta human chorionic gonadotropin (β-hCG) test is positive
- Breastfeeding at the time of randomization
- Bleeding diathesis or other contraindication to anticoagulation
- Any concurrent medical condition requiring mandatory antiplatelet or anticoagulant use
- Concomitant use of strong CYP3A4 inducers (e.g., ongoing use of dilantin, carbamazepine, HIV protease inhibitors) or CYP3A4 inhibitors (e.g., diltiazem, ketoconazole)
- Patient has a severe or fatal comorbid illness that will prevent improvement
Key Trial Info
Start Date :
August 9 2024
Trial Type :
INTERVENTIONAL
Allocation :
ESTIMATED
End Date :
November 1 2026
Estimated Enrollment :
200 Patients enrolled
Trial Details
Trial ID
NCT06551402
Start Date
August 9 2024
End Date
November 1 2026
Last Update
August 13 2024
Active Locations (1)
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1
Kafr Elsheikh University Hospital
Kafr ash Shaykh, Egypt, 33511