Dabigatran Versus Apixaban in Cerebral Venous Thrombosis (NCT06551415) | Clinical Trial Compass
RecruitingPhase 3
Dabigatran Versus Apixaban in Cerebral Venous Thrombosis
Egypt200 participantsStarted 2021-08-01
Plain-language 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 apixaban 5mg Bid were assessed through rate of recurrent VTE, mRS, rate of venous recanalization, HIT score, MoCA test, and central and peripheral hemorrhagic complications
Who can participate
Age range18 Years – 75 Years
SexALL
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Inclusion criteria
✓. 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 criteria
✕. 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
What they're measuring
1
The proportion of subjects who have partial or complete venous recanalization by Day 180