RecruitingPhase 3NCT06531122

Rivaroxaban Versus Apixaban in Cerebral Venous Thrombosis

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

Sponsor

Kafrelsheikh University

Enrollment

200 participants

Start Date

Aug 1, 2021

Study Type

INTERVENTIONAL

Conditions

Cerebral Venous Thrombosis

Summary

Along with the current clinical trial, the efficacy and safety of a 20 mg rivaroxaban administered within 24 hours of randomization after having first-ever cerebral venous thrombosis compared to apixaban 5mg Bid were assessed through rate of recurrent VTE, mRS, rate of venous recanalization, HIT score, MoCA test, and central and peripheral heamoragic complications.

Eligibility

Min Age: 18 YearsMax Age: 75 Years

Inclusion Criteria5

Patients aged 18 and above
New diagnosis of symptomatic cerebral venous thrombosis as confirmed on CT/CT venogram or MRI/MR venogram
Ability to randomize within 14 days of neuroimaging-confirmed diagnosis
The treating clinician is of the opinion that the patient is appropriate for oral anticoagulation as per the standard of care
The patient or legally authorized representative is able to give written informed consent

Exclusion Criteria10

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

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Interventions

DRUGApixaban 5MG

100 CVT patients will receive apixaban 5mg Bid for 6 months. We will assess the Proportion of subjects who have partial or complete venous recanalization by Day 180 the rate of drug hemorrhagic complications using the PLATO bleeding definition, and the rates of patients who achieved a favorable outcome with (mRS = 0-2) after one week and after 180 days in a face-to-face interview in the outpatient clinic, Proportion of subjects with recurrent venous thromboembolism (any thrombosis at a new site, including cerebral venous thrombosis in a separate location from the index event) at Day 180 or the end of anticoagulation, whichever is sooner, rates of a composite of pulmonary embolism, DVT, myocardial infarction, and death due to vascular events after 180 days of follow-up, the MoCA, HIT-6 by 180 days, the rate of treatment-related adverse effects assessed by a follow-up questionnaire

DRUGRivaroxaban 20 MG Oral Tablet

100 CVT patients will receive Rivaroxaban 20mg daily for 6 months. We will assess the Proportion of subjects who have partial or complete venous recanalization by Day 180 the rate of drug hemorrhagic complications using the PLATO bleeding definition, and the rates of patients who achieved a favorable outcome with (mRS = 0-2) after one week and after 180 days in a face-to-face interview in the outpatient clinic, Proportion of subjects with recurrent venous thromboembolism (any thrombosis at a new site, including cerebral venous thrombosis in a separate location from the index event) at Day 180 or the end of anticoagulation, whichever is sooner, rates of a composite of pulmonary embolism, DVT, myocardial infarction, and death due to vascular events after 180 days of follow-up, the MoCA, HIT-6 by 180 days, the rate of treatment-related adverse effects assessed by a follow-up questionnaire