Dabigatran Versus Rivaroxaban in Cerebral Venous Thrombosis
ConditionCerebral Venous Sinus Thrombosis
Trial statusRecruiting
Trial phasePhase 3
Trial typeInterventional
Biological sexAll
Age18-75
SponsorKafrelsheikh University
About this trial
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
Eligibility criteria
Qualifiers
1-Patients aged 18 and above 2-New diagnosis of symptomatic cerebral venous thrombosis as confirmed on CT/CT venogram or MRI/MR venogram 3-Ability to randomize within 14 days of neuroimaging-confirmed diagnosis 4-The treating clinician thinks that the patient is appropriate for oral anticoagulation as per the standard of care 5-The patient or legally authorized representative can give written informed consent
Disqualifiers
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) prior to initiation of oral anticoagulation
Patient is unable to swallow due to depressed level of consciousness
Impaired renal function (i.e., CrCl < 30 mL/min using CockroftGault equation)
Trial design
Treatments tested in this trial
- Dabigatran Etexilate 150mg
- Rivaroxaban 20 MG Oral Tablet
Treatment groups
200 Participants
are divided into 2 treatment groupsSponsors and collaborators
Source ClinicalTrials.gov