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

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ClinicalTrials.gov Identifier: NCT03191305
Recruitment Status : Not yet recruiting
First Posted : June 19, 2017
Last Update Posted : June 19, 2017
Sponsor:
Collaborator:
Shaheed Zulfiqar Ali Bhutto Medical University
Information provided by (Responsible Party):
Foundation University Islamabad

Brief Summary:
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

Condition or disease Intervention/treatment Phase
Cerebral Venous Thrombosis Drug: Coumadin Drug: Rivoroxaban Not Applicable

  Show Detailed Description

Study Type : Interventional  (Clinical Trial)
Estimated Enrollment : 50 participants
Allocation: Non-Randomized
Intervention Model: Parallel Assignment
Intervention 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 (Participant)
Masking Description: Only Participants would not know about the any other choice of the Drug available.
Primary Purpose: Health Services Research
Official Title: Comparison of the Efficacy of Rivroxaban to Coumadin( Warfarin ) in Cerebral Venous Thrombosis
Estimated Study Start Date : August 2017
Estimated Primary Completion Date : September 2018
Estimated Study Completion Date : September 2018

Resource links provided by the National Library of Medicine


Arm Intervention/treatment
Active Comparator: Coumadin Group
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
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.

Active Comparator: Rivoroxaban Group
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
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.




Primary Outcome Measures :
  1. Hemorrhage or Recurrent CVT based on repeat MRI. [ Time Frame: 6 months ]
    Outcome measures will include any hemorrhage or recurrent CVT based on repeat MRI.


Secondary Outcome Measures :
  1. Cost [ Time Frame: 6 months ]
    Comparison of cost of two treatment groups.



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Ages Eligible for Study:   13 Years to 50 Years   (Child, Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No
Criteria

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


Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT03191305


Contacts
Contact: Saira Saad, MBBS,MRCP,FCPS(Neurology) +92 334 9555 456 sairaiqbl@hotmail.com
Contact: Haris Majid, MBBS,FCPS(Neurology) +92 333 516 3322 harismajid@gmail.com

Sponsors and Collaborators
Foundation University Islamabad
Shaheed Zulfiqar Ali Bhutto Medical University

Publications:
Responsible Party: Foundation University Islamabad
ClinicalTrials.gov Identifier: NCT03191305     History of Changes
Other Study ID Numbers: FUI/CTR/2017/2
First Posted: June 19, 2017    Key Record Dates
Last Update Posted: June 19, 2017
Last Verified: June 2017
Individual Participant Data (IPD) Sharing Statement:
Plan to Share IPD: No

Studies a U.S. FDA-regulated Drug Product: No
Studies a U.S. FDA-regulated Device Product: No
Product Manufactured in and Exported from the U.S.: No

Additional relevant MeSH terms:
Thrombosis
Venous Thrombosis
Embolism and Thrombosis
Vascular Diseases
Cardiovascular Diseases
Warfarin
Anticoagulants