Comparing Treatment Outcomes in CVT Patients Who Treated With Warfarin and Rivaroxaban in Isfahan, Iran
Overview
- Phase
- Phase 1
- Enrollment
- 50
- Locations
- 1
- Primary Endpoint
- Modified Rankin Scale
Overview
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.
Study Design
- Study Type
- Interventional
- Allocation
- Randomized
- Intervention Model
- Parallel
- Primary Purpose
- Treatment
- Masking
- None
Eligibility Criteria
- Ages
- 18 Years to — (Adult, Older Adult)
- Sex
- All
- Accepts Healthy Volunteers
- No
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
Arms & Interventions
Rivoroxaban
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.
Intervention: Rivaroxaban (Drug)
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
Intervention: Warfarin (Drug)
Outcomes
Primary Outcomes
Modified Rankin Scale
Time Frame: 3 months
based on disability grade(0-6). 0 indicate patients have no disability and the worst score is 6.
Secondary Outcomes
- hemorrhagic rate(3 months)
- Stroke(3 months)
Investigators
Mohammad Saadatnia
Professor Mohammad Saadatnia
Isfahan University of Medical Sciences