Dabigatran Versus Rivaroxaban in Cerebral Venous Thrombosis

Recruiting now · Phase 3

Conditions studied: Cerebral Venous Sinus Thrombosis

In brief

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

Key facts

Study ID

NCT06551402

Run by

Kafrelsheikh University

People needed

200

Starts

2024-08-09

Expected to finish

2026-11-01

Last updated by the study team

2024-08-13

Who can join

Age: 18 and older, up to 75. Sex: any. Healthy volunteers: not accepted.

You may qualify if…

• 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

You may not qualify if…

• 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)
• Pregnancy; if a woman is of childbearing potential a urine or serum beta human chorionic gonadotropin (β-hCG) test is positive
• Breastfeeding at the time of randomization
• Bleeding diathesis or other contraindication to anticoagulation
• Any concurrent medical condition requiring mandatory antiplatelet or anticoagulant use
• Concomitant use of strong CYP3A4 inducers (e.g., ongoing use of dilantin, carbamazepine, HIV protease inhibitors) or CYP3A4 inhibitors (e.g., diltiazem, ketoconazole)
• Patient has a severe or fatal comorbid illness that will prevent improvement

Where it is running

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

Full record on ClinicalTrials.gov

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