Rivaroxaban Versus Apixaban in Cerebral Venous Thrombosis
- Conditions
- Cerebral Venous Thrombosis
- Interventions
- Registration Number
- NCT06531122
- Lead Sponsor
- Kafrelsheikh University
- Brief 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.
- Detailed 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
Recruitment & Eligibility
- Status
- RECRUITING
- Sex
- All
- Target Recruitment
- 200
- 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
- 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
Study & Design
- Study Type
- INTERVENTIONAL
- Study Design
- PARALLEL
- Arm && Interventions
Group Intervention Description rivaroxaban Rivaroxaban 20 MG Oral Tablet 100 CVT patients will receive rivaroxaban 20mg daily for 6 months apixaban Apixaban 5MG 100 CVT patients will receive apixaban 5mg Bid for 6 months
- Primary Outcome Measures
Name Time Method Rate of drug-related hemorrhagic complications 180 days the rate of drug hemorrhagic complications which was evaluated using the PLATO bleeding definition which classified hemorrhagic complications into three types as follows: Major bleeding which had one or more of the following criteria: fatal bleeding, intracranial, intrapericardial, bleeding associated with reduction of hemoglobin \> 3-5 g/dl, bleeding required transfusion of two to four units whole blood or PRBCs, bleeding produced hypovolemic shock or severe hypotension that required pressor or surgery; Minor bleeding that required medical intervention to stop or treat bleeding: Minimal bleeding: any bleeding that did not require intervention or treatment such as bruising, bleeding gums, oozing from injection sites.
The proportion of subjects who have partial or complete venous recanalization by Day 180 180 days the investigators will perform magnetic resonance venography for all patients after 6 months to show if there is partial or complete recanalization of the affected venous sinus
- Secondary Outcome Measures
Name Time Method rate of drug adverse effects 6 months Drug adverse effects: all non-hemorrhagic side effects related to the drugs of our study will be reported
value of Modified Rankin Scale (mRS) at six months 6 months mRS measures the degree of disability or dependence in the daily activities of people who have suffered a stroke or other causes of neurological disability. Its value ranges from 0 to 6; the lower the score, the better the stroke outcome. A favorable stroke outcome is considered with an mRS value equal to two or less.
value of HIT-6 score in each group after six months of treatment 6 months The investigators assessed the absolute change in HIT6 score, the Headache Impact Test-6 (HIT-6) assessed the burden of headache in each group; the HIT-6 consists of six items: pain, social functioning, role functioning, vitality, cognitive functioning, and psychological distress, the patient answers each of the six related questions using one of the following five responses: "never", "rarely", "sometimes", "very often," or "always." These responses are summed to produce a total HIT-6 score that ranges from 36 to 78, where a higher score indicates a greater impact of headache on the daily life of the respondent. It has four impact grades: little-to-no impact (HIT-6 score: 36-49), moderate impact (HIT-6 score: 50-55), substantial impact (HIT-6 score: 56-59), and severe impact (HIT-6 score: 60-78)
The proportion of participants with recurrent venous thromboembolism 6 months The investigators will assess the proportion of participants with recurrent venous thromboembolism (any thrombosis at a new site, including CVT in a separate location from the index event) during 6 months of treatment
rate of composite pulmonary embolism, myocardial infarction, and death due to vascular events 6 months The investigators will assess the proportion of participants with pulmonary embolism, myocardial infarction, and death due to vascular events at during 6 months of treatment
Trial Locations
- Locations (1)
Kafr Elsheikh University Hospital
🇪🇬Kafr Ash Shaykh, Egypt