Status:
RECRUITING
Dabigatran Versus Apixaban 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 a...
Detailed Description
The investigators conducted a single-blinded randomized controlled trial between August 2021 and August 2024 after the ethics committee of the faculty of medicine at Kafr el-Sheik University approved ...
Eligibility Criteria
Inclusion
- Patients aged 18 and above
- New diagnosis of symptomatic cerebral venous thrombosis as confirmed on CT/CT venogram or MRI/MR venogram
- Ability to randomize within 14 days of neuroimaging-confirmed diagnosis
- The treating clinician thinks that the patient is appropriate for oral anticoagulation as per the standard of care
- 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) before initiation of oral anticoagulation
- Patient is unable to swallow due to a 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)
- The patient has a severe or fatal comorbid illness that will prevent improvement
Key Trial Info
Start Date :
August 1 2021
Trial Type :
INTERVENTIONAL
Allocation :
ESTIMATED
End Date :
October 1 2024
Estimated Enrollment :
200 Patients enrolled
Trial Details
Trial ID
NCT06551415
Start Date
August 1 2021
End Date
October 1 2024
Last Update
August 13 2024
Active Locations (1)
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1
Kafr Elsheikh University Hospital
Kafr ash Shaykh, Egypt, 33511