Efficacy Comparison of Warfarin Versus Rivaroxaban CVT

Study Overview
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Brief Summary
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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.

Official Title
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Comparing Treatment Outcomes in CVT Patients Who Treated With Warfarin and Rivaroxaban in Isfahan, Iran

Conditions
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Cerebral Venous Thrombosis

Intervention / Treatment
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* Drug: Rivaroxaban
* Drug: Warfarin


Participation Criteria
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Eligibility Criteria
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IInclusion 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

Ages Eligible for Study
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Minimum Age: 18 Years

Sexes Eligible for Study
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All

Accepts Healthy Volunteers
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No

Study Plan
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How is the study designed?
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Design Details

Primary Purpose: Treatment
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: None (Open Label)


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Experimental: Rivoroxaban<br>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. | Drug: Rivaroxaban<br>* Rivaroxaban will administrate to patient with CVT. In first day, enoxaparin is injected to patients and the next day, patients will receive Rivaroxaban and enoxaparin discontinue. Then, patients receive Rivaroxaban for 3 months daily.<br>* Other names: Xarelto;|
| Active Comparator: warfarin<br>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 | Drug: Warfarin<br>* Warfarin as a antocoagolant drug will administrate to patient with CVT. In first day, Warfarin plus enoxaparin until adjusting INR index to 2-3. Then, patients receive warfarin for 3 months daily.<br>* Other names: Coumadin;|

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Modified Rankin Scale | based on disability grade(0-6). 0 indicate patients have no disability and the worst score is 6. | 3 months | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| hemorrhagic rate | based on repeat MRI | 3 months | 
| Stroke | based on MRI | 3 months |