Comparing Dabigatran and Rivaroxaban for Treating Cerebral Venous Sinus Thrombosis in Adults

What this Trial Is About

Researchers are evaluating the safety and effectiveness of two blood-thinning drugs, dabigatran and rivaroxaban, for treating patients who have had their first cerebral venous thrombosis. This randomized controlled trial aims to compare how well a 150 mg twice daily dose of dabigatran works versus a 20 mg daily dose of rivaroxaban. The study will assess outcomes such as rates of recurrent venous thromboembolism, brain vein reopening, neurological function, and bleeding complications. The trial includes two groups of 100 patients each. One group receives dabigatran 150 mg twice daily, while the other takes rivaroxaban 20 mg once daily, both for six months. Participants will undergo clinical evaluations, brain scans, heart monitoring, blood tests, and neurological assessments at the start and at 30, 90, and 180 days. Imaging will be done at baseline and after six months, with urgent scans if clinical worsening occurs. Participants will be closely followed through interviews and questionnaires to measure brain function, headache impact, bleeding events, and other side effects. The main outcomes include the proportion of patients with partial or complete reopening of brain veins and the rate of bleeding complications by 180 days. Additional measures include neurological recovery, recurrent clots, and vascular events. Safety and treatment effects will be monitored throughout the study, which runs from August 2024 to November 2026.

Dabigatran Versus Rivaroxaban in Cerebral Venous Thrombosis