Dabigatran Versus Rivaroxaban in Cerebral Venous Thrombosis
NCT Number: NCT06551402
Status: RECRUITING
Study Type: INTERVENTIONAL
Phases: PHASE3
Conditions: Cerebral Venous Sinus Thrombosis
Interventions: DRUG: Dabigatran Etexilate 150mg|DRUG: Rivaroxaban 20 MG Oral Tablet
Sponsor: Kafrelsheikh University
Sex: ALL
Age: ADULT, OLDER_ADULT
Enrollment: 200
Study Design: Allocation: RANDOMIZED|Intervention Model: PARALLEL|Masking: DOUBLE (INVESTIGATOR, OUTCOMES_ASSESSOR)|Primary Purpose: TREATMENT
Start Date: 2024-08-09
Completion Date: 2026-11-01
Locations: Kafr Elsheikh University Hospital, Kafr Ash Shaykh, 33511, Egypt

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

Primary Outcome Measures: The proportion of subjects who have partial or complete venous recanalization by Day 180, the investigators will perform magnetic resonance venography for all patients after 6 months to show if there is partial or complete recanalization of the affected venous sinus, 180 days|Rate of drug-related hemorrhagic complications, the rate of drug hemorrhagic complications which was evaluated using the PLATO bleeding definition which classified hemorrhagic complications into three types as follows: Major bleeding which had one or more of the following criteria: fatal bleeding, intracranial, intrapericardial, bleeding associated with reduction of hemoglobin \> 3-5 g/dl, bleeding required transfusion of two to four units whole blood or PRBCs, bleeding produced hypovolemic shock or severe hypotension that required pressor or surgery; Minor bleeding that required medical intervention to stop or treat bleeding: Minimal bleeding: any bleeding that did not require intervention or treatment such as bruising, bleeding gums, oozing from injection sites., 180 days
Secondary Outcome Measures: value of Modified Rankin Scale (mRS) at six months, mRS measures the degree of disability or dependence in the daily activities of people who have suffered a stroke or other causes of neurological disability. Its value ranges from 0 to 6; the lower the score, the better the stroke outcome. A favorable stroke outcome is considered with an mRS value equal to two or less., 6 months|value of HIT-6 score in each group after six months of treatment, The investigators assessed the absolute change in HIT6 score, the Headache Impact Test-6 (HIT-6) assessed the burden of headache in each group; the HIT-6 consists of six items: pain, social functioning, role functioning, vitality, cognitive functioning, and psychological distress, the patient answers each of the six related questions using one of the following five responses: "never", "rarely", "sometimes", "very often," or "always." These responses are summed to produce a total HIT-6 score that ranges from 36 to 78, where a higher score indicates a greater impact of headache on the daily life of the respondent. It has four impact grades: little-to-no impact (HIT-6 score: 36-49), moderate impact (HIT-6 score: 50-55), substantial impact (HIT-6 score: 56-59), and severe impact (HIT-6 score: 60-78), 6 months|rate of drug adverse effects, Drug adverse effects: all non-hemorrhagic side effects related to the drugs of our study will be reported, 6 months|The proportion of participants with recurrent venous thromboembolism, The investigators will assess the proportion of participants with recurrent venous thromboembolism (any thrombosis at a new site, including CVT in a separate location from the index event) during 6 months of treatment, 6 months|rate of composite pulmonary embolism, myocardial infarction, and death due to vascular events, The investigators will assess the proportion of participants with pulmonary embolism, myocardial infarction, and death due to vascular events at during 6 months of treatment, 6 months