Comparison of the Efficacy of Rivroxaban to Coumadin( Warfarin ) in Cerebral Venous Thrombosis (CVT)
|The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Know the risks and potential benefits of clinical studies and talk to your health care provider before participating. Read our disclaimer for details.|
|ClinicalTrials.gov Identifier: NCT03191305|
Recruitment Status : Not yet recruiting
First Posted : June 19, 2017
Last Update Posted : June 19, 2017
|Condition or disease||Intervention/treatment|
|Cerebral Venous Thrombosis||Drug: Coumadin Drug: Rivoroxaban|
Show Detailed Description
|Study Type :||Interventional (Clinical Trial)|
|Estimated Enrollment :||50 participants|
|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 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|
|Anticipated Study Start Date :||August 2017|
|Estimated Primary Completion Date :||September 2018|
|Estimated Study Completion Date :||September 2018|
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.
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.
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.
- 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.
- Cost [ Time Frame: 6 months ]Comparison of cost of two treatment groups.
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
|Contact: Saira Saad, MBBS,MRCP,FCPS(Neurology)||+92 334 9555 email@example.com|
|Contact: Haris Majid, MBBS,FCPS(Neurology)||+92 333 516 firstname.lastname@example.org|