Comparing Dabigatran and Rivaroxaban for Treating Cerebral Venous Thrombosis

Dabigatran Versus Rivaroxaban in Cerebral Venous Thrombosis, a Randomized Controlled Trial

This study is testing whether dabigatran or rivaroxaban works better for treating people who have had their first cerebral venous thrombosis.

Quick facts

• Phase: Phase 3
• Study type: Interventional
• Enrollment: 200 (estimated)
• Ages: 18 Years to 75 Years
• Sex: All
• Sponsor: Kafrelsheikh University (Academic / other)
• Locations: 1 site (Kafr ash Shaykh)
• Trial ID: NCT06551402 on ClinicalTrials.gov

What this trial studies

This clinical trial evaluates the efficacy and safety of dabigatran versus rivaroxaban in patients with first-ever cerebral venous thrombosis. It is a single-blinded randomized controlled trial involving 200 patients, with 100 receiving dabigatran and 100 receiving rivaroxaban for six months. The study assesses outcomes such as the rate of recurrent venous thromboembolism, venous recanalization, and various clinical assessments at multiple follow-up points. The trial is conducted at Kafr Elsheikh University Hospital in Egypt, following ethical approval and informed consent from participants.

Who should consider this trial

Good fit: Ideal candidates are adults aged 18 and above with a new diagnosis of symptomatic cerebral venous thrombosis confirmed by neuroimaging.

Not a fit: Patients with known antiphospholipid antibody syndrome, impaired renal function, or those requiring invasive procedures prior to anticoagulation may not benefit from this study.

Why it matters

Potential benefit: If successful, this study could provide insights into more effective anticoagulation therapy for patients with cerebral venous thrombosis.

How similar studies have performed: Other studies have explored anticoagulation therapies for venous thrombosis, but this specific comparison of dabigatran and rivaroxaban in cerebral venous thrombosis is relatively novel.

Eligibility criteria

Inclusion Criteria:

* 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

Exclusion Criteria:

1. The patient has known antiphospholipid antibody syndrome with a previous history of venous or arterial thrombosis
2. The patient is anticipated to require invasive procedures (e.g., lumbar puncture, thrombectomy, hemicraniectomy) prior to initiation of oral anticoagulation
3. Patient is unable to swallow due to depressed level of consciousness
4. Impaired renal function (i.e., CrCl \< 30 mL/min using CockroftGault equation)
5. Pregnancy; if a woman is of childbearing potential a urine or serum beta human chorionic gonadotropin (β-hCG) test is positive
6. Breastfeeding at the time of randomization
7. Bleeding diathesis or other contraindication to anticoagulation
8. Any concurrent medical condition requiring mandatory antiplatelet or anticoagulant use
9. Concomitant use of strong CYP3A4 inducers (e.g., ongoing use of dilantin, carbamazepine, HIV protease inhibitors) or CYP3A4 inhibitors (e.g., diltiazem, ketoconazole)
10. Patient has a severe or fatal comorbid illness that will prevent improvement

Where this trial is running

Kafr ash Shaykh

• Kafr Elsheikh University Hospital — Kafr ash Shaykh, Egypt (Recruiting)

Study contacts

• Principal investigator: mohamed G. Zeinhom, MD — neurology department kafr el-sheikh university
• Study coordinator: mohamed G. Zeinhom, MD

Conditions Cerebral Venous Sinus Thrombosis; rivaroxaban; dabigatran; Egypt; cerebral venous thrombosis