Comparing Dabigatran and Apixaban for Treating Cerebral Venous Sinus Thrombosis A Phase 3 Randomized, Double-Blind Trial in Adults Aged 18 to 75

What this Trial Is About

Researchers are evaluating the safety and effectiveness of two blood-thinning medications, dabigatran and apixaban, for adults who have experienced their first cerebral venous thrombosis CVT, a type of blood clot in the brains veins. This randomized controlled trial compares these two treatments by measuring rates of clot recurrence, recovery outcomes, vein reopening, headache impact, cognitive function, and bleeding complications over six months. Participants are randomly assigned to receive either dabigatran 150 mg twice daily or apixaban 5 mg twice daily for six months. The study includes two groups of 100 patients each. Throughout the study, patients undergo clinical evaluations, brain imaging scans, blood tests, heart and carotid artery monitoring when needed, and cognitive and headache assessments at baseline and at 30, 90, and 180 days. During the trial, participants will be monitored for venous recanalization by day 180 and for any bleeding complications related to the medication. Researchers will also assess functional recovery using the Modified Rankin Scale, cognitive ability with the MoCA test, headache severity with HIT-6, and any recurrent blood clots or vascular events such as pulmonary embolism or heart attack. Safety and treatment-related side effects will be tracked through follow-up questionnaires, ensuring comprehensive monitoring over the full six-month period.

Dabigatran Versus Apixaban in Cerebral Venous Thrombosis