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Dabigatran Versus Rivaroxaban in Cerebral Venous Thrombosis
Sponsor: Kafrelsheikh University
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 20 mg rivaroxaban were assessed through rate of recurrent VTE, mRS, rate of venous recanalization, HIT score, MoCA test, and central and peripheral hemorrhagic complications
Official title: Dabigatran Versus Rivaroxaban in Cerebral Venous Thrombosis, a Randomized Controlled Trial
Key Details
Gender
All
Age Range
18 Years - 75 Years
Study Type
INTERVENTIONAL
Enrollment
200
Start Date
2024-08-09
Completion Date
2026-11-01
Last Updated
2024-08-13
Healthy Volunteers
No
Conditions
Interventions
Dabigatran Etexilate 150mg
100 CVT patients will receive dabigatran 150mg Bid for 6 months. We will assess the Proportion of subjects who have partial or complete venous recanalization by Day 180 the rate of drug hemorrhagic complications using the PLATO bleeding definition, and the rates of patients who achieved a favorable outcome with (mRS = 0-2) after one week and after 180 days in a face-to-face interview in the outpatient clinic, Proportion of subjects with recurrent venous thromboembolism (any thrombosis at a new site, including cerebral venous thrombosis in a separate location from the index event) at Day 180 or the end of anticoagulation, whichever is sooner, rates of a composite of pulmonary embolism, DVT, myocardial infarction, and death due to vascular events after 180 days of follow-up, the MoCA, HIT-6 by 180 days, the rate of treatment-related adverse effects assessed by a follow-up questionnaire.
Rivaroxaban 20 MG Oral Tablet
100 CVT patients will receive Rivaroxaban 20mg daily for 6 months. We will assess the Proportion of subjects who have partial or complete venous recanalization by Day 180 the rate of drug hemorrhagic complications using the PLATO bleeding definition, and the rates of patients who achieved a favorable outcome with (mRS = 0-2) after one week and after 180 days in a face-to-face interview in the outpatient clinic, Proportion of subjects with recurrent venous thromboembolism (any thrombosis at a new site, including cerebral venous thrombosis in a separate location from the index event) at Day 180 or the end of anticoagulation, whichever is sooner, rates of a composite of pulmonary embolism, DVT, myocardial infarction, and death due to vascular events after 180 days of follow-up, the MoCA, HIT-6 by 180 days, the rate of treatment-related adverse effects assessed by a follow-up questionnaire.
Locations (1)
Kafr Elsheikh University Hospital
Kafr ash Shaykh, Egypt