Efficacy Comparison of Warfarin Versus Rivaroxaban CVT

Phase 1

• Conditions: Cerebral Venous Thrombosis
• Interventions: Drug: Rivaroxaban; Drug: Warfarin

• Registration Number: NCT03747081
• Lead Sponsor: Isfahan University of Medical Sciences

Brief Summary

With regard to Cerebral Venous Thrombosis (CVT) importance as a life threatening disease, specific care is necessary, Known anti-coagulants have limitations.Vitamin K antagonists such as Warfarin, require laboratory monitoring and exact administration starting and maintenance dose. although Rivaroxaban(selective and direct Xa factor antagonist ) has no monitoring and no drug interaction. This study aim to focus on efficacy of Warfarin versus Rivaroxaban.

Detailed Description

Not available

Study Timeline

• Study Start: 2018-09-01
• Status Verified: 2018-11
• Study First Submitted: 2018-11-13
• Study First Submitted QC: 2018-11-17
• Last Update Submitted: 2018-11-17
• Study First Posted: 2018-11-20
• Last Update Posted: 2018-11-20
• Primary Completion: 2020-01-01
• Study Completion: 2020-05-01

Recruitment & Eligibility

• Status: UNKNOWN
• Sex: All
• Target Recruitment: 50

Inclusion Criteria

• Patients of both gender
• Age 18 years and higher
• proven CVT on neuro imaging ( MRI-MRV)

Exclusion Criteria

• Patients suffering from renal failure(GFR<30) Patients
• Patients with contraindications for oral anticoagulation
• Patient who having pregnancy
• Uncooperative patient for completing the course of treatment

Study & Design

• Study Type: INTERVENTIONAL
• Study Design: PARALLEL

Arm && Interventions

Group	Intervention	Description
Rivoroxaban	Rivaroxaban	Patients would be administered Enoxaparine (60 mg/SC/BID)in first day, after dicontinuing Enoxaparin in second day, Rivoroxaban 20 mg per day will use. .it would be given once a day.The total duration of Rivoroxaban would be 3 months.
warfarin	Warfarin	Patients would be administered Warfarin with overlap of Enoxaparine utill INR adjust to 2-3 then enoxaparine will disconstinue.it would be given once a day.The total duration of Warfarin would be 3 months

Primary Outcome Measures

Name	Time	Method
Modified Rankin Scale	3 months	based on disability grade(0-6). 0 indicate patients have no disability and the worst score is 6.

Secondary Outcome Measures

Name	Time	Method
hemorrhagic rate	3 months	based on repeat MRI
Stroke	3 months	based on MRI

Trial Locations

Locations (1)

Alzahra University Hospital; 🇮🇷 Isfahan, Iran, Islamic Republic of