Comparing Dabigatran and Apixaban for Treating Cerebral Venous Thrombosis

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

This study is testing whether the blood thinners dabigatran or apixaban work better for 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: NCT06551415 on ClinicalTrials.gov

What this trial studies

This clinical trial evaluates the efficacy and safety of dabigatran versus apixaban in patients with first-ever cerebral venous thrombosis. It is a single-blinded randomized controlled trial involving 200 patients, who will receive either 150 mg of dabigatran or 5 mg of apixaban twice daily 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, with a focus on rigorous monitoring and evaluation of patient responses.

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 or those requiring invasive procedures before anticoagulation may not benefit from this study.

Why it matters

Potential benefit: If successful, this study could provide insights into more effective anticoagulation therapies 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 apixaban in cerebral venous thrombosis is 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) before initiation of oral anticoagulation
3. Patient is unable to swallow due to a 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. The 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; apixaban,; cerebral venous thrombosis; Dabigatran; Egypt