Efficacy Comparison of Warfarin Versus Rivaroxaban 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: NCT03747081|
Recruitment Status : Recruiting
First Posted : November 20, 2018
Last Update Posted : November 20, 2018
|Condition or disease||Intervention/treatment||Phase|
|Cerebral Venous Thrombosis||Drug: Rivaroxaban Drug: Warfarin||Phase 1 Phase 2|
|Study Type :||Interventional (Clinical Trial)|
|Estimated Enrollment :||50 participants|
|Intervention Model:||Parallel Assignment|
|Masking:||None (Open Label)|
|Official Title:||Comparing Treatment Outcomes in CVT Patients Who Treated With Warfarin and Rivaroxaban in Isfahan, Iran|
|Actual Study Start Date :||September 1, 2018|
|Estimated Primary Completion Date :||January 1, 2020|
|Estimated Study Completion Date :||May 1, 2020|
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.
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.
Other Name: Xarelto
Active Comparator: 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
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.
Other Name: Coumadin
- 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.
- hemorrhagic rate [ Time Frame: 3 months ]based on repeat MRI
- Stroke [ Time Frame: 3 months ]based on MRI
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): NCT03747081
|Contact: Mohammad Javad Farajpour Khanaposhtani, MDfirstname.lastname@example.org|
|Iran, Islamic Republic of|
|Alzahra University Hospital||Recruiting|
|Isfahan, Iran, Islamic Republic of, 8174673461|
|Contact: Mohammad Saadatnia, Prof 9131147179 ext 98 email@example.com|
|Principal Investigator:||Mohammad Saadatnia, Prof||Isfahan University of Medical Sciences|