Comparison of the Efficacy of Rivroxaban to Coumadin( Warfarin ) in Cerebral Venous Thrombosis

Study Overview
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Brief Summary
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In past few years new anticoagulants have been developed which directly inhibit thrombin or factor X.factor x inhibitor is available in Pakistan. The superior efficacy of Rivroxaban has been shown in Deep Venous Thrombosis in EINSTEIN study (3).Its definite superiority in prevention of embolic stroke in nonvalvular atrial fibrillation is evidenced by the study ROCKET AF (4). With Rivroxaban no monitoring is required, and also there are no drug interactions .There are few pilot studies of using Rivroxaban in cerebral venous thrombosis. This study is therefore required to find its efficacy in CVT patients as well as its comparison with Coumadin

Detailed Description
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Cerebral venous thrombosis is rare form of stroke, accounting .5 to 1% only (1)Exact estimate for Pakistani population is not known Mubarak et al described 6- year imaging incidence and prevalence of CVST to be 10.22% and 11.055% respectively(2) .Majority of cerebral venous stroke patients are females in reproductive age. Coumadin is one of the notorious drugs to be used in pregnancy categorized as X. it also has many drug interactions .and there are diet restrictions too being on Coumadin. It also requires maintanence of prothrombin time in certain range which means patient has to go under phlebotomy at least twice a month. Moreover not all laboratories are well equipped resulting in poor test sensitivity. and at times clinicians keep patients on suboptimum doses for fear of bleeding ending with poor efficacy. In past few years new anticoagulants have been developed which directly inhibit thrombin or factor X.factor x inhibitor is available in Pakistan. The superior efficacy of Rivroxaban has been shown in Deep Venous Thrombosis in EINSTEIN study (3).Its definite superiority in prevention of embolic stroke in nonvalvular atrial fibrillation is evidenced by the study ROCKET AF (4). With Rivroxaban no monitoring is required, and also there are no drug interactions .There are few pilot studies of using Rivroxaban in cerebral venous thrombosis. This study is therefore required to find its efficacy in CVT patients as well as its comparison with Coumadin . OBJECTIVE To Compare the efficacy of Rivroxaban to Warfarin in Cerebral Venous Thrombosis MATERIAL AND METHODS STUDY DESIGN: Quasi Experimental; Descriptive cross sectional DURATION OF STUDY: 6 months to 1 year SAMLE SIZE : 50 patients SAMPLING TECHNIQUE : Consecutive (non probability) sampling. INCLUSION CRITERIA: Patients of either gender Age between 13 years and 50 years Patients with proven CVT on neuro imaging (CTV, o MRV) EXCLUSION CRITERIA: Patients suffering from Chronic Liver disesase Patients having contraindications for oral anticoagulation Patients suffering from hematological or brain malignancy Patients whose MRV and CTV do not support CVT DATA COLLECTION PROCEDURE After taking permission from hospital ethical review committee , All patients with confirmed CVT based on established criteria using any NOAC or WARFARIN presenting to PIMS or FFH hospitals will be enrolled. Data will be obtained by retrospective manner if they are using anticoagulants for more than 6 months. If patients are using anticoagulants for less than 6 months, they will be enrolled and followed up for six months. DATA ANALYSIS The data will be analyzed using SPSS version 16.0. Descriptive analysis will be done and reported as mean ± SD for continuous variables like age whereas frequencies and percentages will be calculated for categorical variables such as gender, individual risk factors. P-value ≤ 0.05 will be significant. Results will be presented in tabulated or graphical forms. Outcome measures Outcome measures will include any hemorrhage or recurrent CVT based on repeat MRI. MRs Scale Secondary Outcome Comparison of cost of two treatment groups.

Official Title
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Comparison of the Efficacy of Rivroxaban to Coumadin( Warfarin ) in Cerebral Venous Thrombosis

Conditions
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Cerebral Venous Thrombosis

Intervention / Treatment
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* Drug: Coumadin
* Drug: Rivoroxaban


Participation Criteria
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Eligibility Criteria
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Inclusion Criteria: Patients of either gender Age between 13 years and 50 years Patients with proven CVT on neuro imaging (CTV, o MRV) - Exclusion Criteria: Patients suffering from Chronic Liver disesase Patients having contraindications for oral anticoagulation Patients suffering from hematological or brain malignancy Patients whose MRV and CTV do not support CVT -

Ages Eligible for Study
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Minimum Age: 13 Years
Maximum Age: 50 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: Health Services Research
Allocation: Non-Randomized
Intervention Model: Parallel Assignment
Interventional Model Description: Patients of CVT from Fauji Foundation would be be in Coumadin Arm ,and patients of CVT from Pakistan Institute of Medical Sciences Hospital would be in Rivroxaban arm.
Masking: Single


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Active Comparator: Coumadin Group<br>Patients in Coumadin Group would be administered Coumadin with overlap of heparin for first two days followed by Coumadin given orally ,dose being adjusted according to INR .The INR range would be between 2-3.it would be given once a day.The total duration OFf coumadin would be six months. | Drug: Coumadin<br>* Patients in Coumadin Group would be administered Coumadin with overlap of heparin for first two days followed by Coumadin given orally ,dose being adjusted according to INR .The INR range would be between 2-3.it would be given once a day. The total duration Of coumadin would be six months.<br>|
| Active Comparator: Rivoroxaban Group<br>The dose protocol would be similar to the one used in Deep Venous Thrombosis. 15 mg PO q12hr for 21 days with food, THEN 20 mg PO qDay for 6 months. | Drug: Rivoroxaban<br>* The dose protocol would be similar to the one used in Deep Venous Thrombosis. 15 mg PO q12hr for 21 days with food, Then 20 mg PO qDay for 6 months.<br>|

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Hemorrhage or Recurrent CVT based on repeat MRI. | Outcome measures will include any hemorrhage or recurrent CVT based on repeat MRI. | 6 months | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Cost | Comparison of cost of two treatment groups. | 6 months |