Ignite Creation Date:
2024-10-26 @ 3:36 PM
Last Modification Date:
2024-10-26 @ 3:36 PM
Study NCT ID:
NCT06531122
Status:
RECRUITING
Last Update Posted:
None
First Post:
2024-07-28
Brief Title:
Rivaroxaban Versus Apixaban in Cerebral Venous Thrombosis
Sponsor:
None
Organization:
None
Study Overview
Official Title:
Rivaroxaban Versus Apixaban in Cerebral Venous Thrombosis a Randomized Controlled Trial
Status:
RECRUITING
Status Verified Date:
2024-08
Last Known Status:
None
Delayed Posting:
No
If Stopped, Why?:
Not Stopped
Has Expanded Access:
No
If Expanded Access, NCT#:
N/A
Has Expanded Access, NCT# Status:
N/A
Acronym:
None
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 3090180 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 hisher 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
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 3090180 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 hisher 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
Study Oversight
Has Oversight DMC:
None
Is a FDA Regulated Drug?:
None
Is a FDA Regulated Device?:
None
Is an Unapproved Device?:
None
Is a PPSD?:
None
Is a US Export?:
None
Is an FDA AA801 Violation?:
None