Rivaroxaban Versus Apixaban in Cerebral Venous Thrombosis

Phase

Condition

Thrombosis

Vascular Diseases

Venous Thromboembolism

Treatment

Apixaban 5MG

Rivaroxaban 20 MG Oral Tablet

Clinical Study ID

NCT06531122

230988167

Ages 18-75
All Genders

Study 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 Criteria

Inclusion

Inclusion Criteria:

Patients aged 18 and above
New diagnosis of symptomatic cerebral venous thrombosis as confirmed on CT/CTvenogram 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 oralanticoagulation as per the standard of care
The patient or legally authorized representative is able to give written informedconsent

Exclusion

Exclusion Criteria:

The patient has known antiphospholipid antibody syndrome with a previous history ofvenous 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 humanchorionic 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 anticoagulantuse
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

Study Design

Apixaban 5MG

August 01, 2021

September 20, 2024

Study Description

The investigators conducted a single-blinded randomized controlled trial between August 2021 and August 2024 after the ethics committee of the faculty of medicine at Kafr el-Sheik University approved it.

The investigators got written informed consent from all eligible patients or their first order of kin before randomization.

The study will be composed of 2 arms rivaroxaban arm, which consisted of 100 patients who received 20mg rivaroxaban daily for 6 months, and the apixaban arm, consisting of 100 patients who received (5 mg Bid for 6 months),

Study Procedures:

Every patient in our study will undergo:

Clinical workup: History, clinical assessment, NIHSS, MoCA, HIT-6, and mRS were recorded at baseline and at 30,90,180 days as a follow-up.

Detection of Risk Factors & Profiles:

Echocardiography TTE: in indicated patients ECG Monitoring: daily ECG monitoring will be performed in indicated patients. 3- Carotid Duplex: carotid duplex in indicated patients.

4- ESR & Lipid Profile& liver functions: All will be tested routinely for all patients.

5- Non-contrast CT brain and CTV on admission or MRI and MRV:, at baseline and after 6 months of treatment CT brain: Any patient with unexplained clinical deterioration at any time throughout his/her hospital stay will be urgently imaged by CT.

Primary End Point:

The primary efficacy outcome was the rate of Proportion of subjects who have partial or complete venous recanalization by Day 180, and the primary safety outcome was the rate of drug hemorrhagic complications using the PLATO bleeding definition.

• Secondary End Point: The secondary efficacy outcomes were to evaluate 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, while the secondary safety outcome was the rate of treatment-related adverse effects assessed by a follow-up questionnaire

Connect with a study center

Kafr Elsheikh University Hospital
Kafr Ash Shaykh, 33511
Egypt
Active - Recruiting

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