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Efficacy Comparison of Warfarin Versus Rivaroxaban CVT

Primary Purpose

Cerebral Venous Thrombosis

Status
Unknown status
Phase
Phase 1
Locations
Iran, Islamic Republic of
Study Type
Interventional
Intervention
Rivaroxaban
Warfarin
Sponsored by
Isfahan University of Medical Sciences
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional treatment trial for Cerebral Venous Thrombosis

Eligibility Criteria

18 Years - undefined (Adult, Older Adult)All SexesDoes not accept healthy volunteers

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

Sites / Locations

  • Alzahra University HospitalRecruiting

Arms of the Study

Arm 1

Arm 2

Arm Type

Experimental

Active Comparator

Arm Label

Rivoroxaban

warfarin

Arm Description

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.

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

Outcomes

Primary Outcome Measures

Modified Rankin Scale
based on disability grade(0-6). 0 indicate patients have no disability and the worst score is 6.

Secondary Outcome Measures

hemorrhagic rate
based on repeat MRI
Stroke
based on MRI

Full Information

First Posted
November 13, 2018
Last Updated
November 17, 2018
Sponsor
Isfahan University of Medical Sciences
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1. Study Identification

Unique Protocol Identification Number
NCT03747081
Brief Title
Efficacy Comparison of Warfarin Versus Rivaroxaban CVT
Official Title
Comparing Treatment Outcomes in CVT Patients Who Treated With Warfarin and Rivaroxaban in Isfahan, Iran
Study Type
Interventional

2. Study Status

Record Verification Date
November 2018
Overall Recruitment Status
Unknown status
Study Start Date
September 1, 2018 (Actual)
Primary Completion Date
January 1, 2020 (Anticipated)
Study Completion Date
May 1, 2020 (Anticipated)

3. Sponsor/Collaborators

Responsible Party, by Official Title
Principal Investigator
Name of the Sponsor
Isfahan University of Medical Sciences

4. Oversight

Studies a U.S. FDA-regulated Drug Product
No
Studies a U.S. FDA-regulated Device Product
No
Data Monitoring Committee
No

5. Study Description

Brief Summary
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.

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Cerebral Venous Thrombosis

7. Study Design

Primary Purpose
Treatment
Study Phase
Phase 1, Phase 2
Interventional Study Model
Parallel Assignment
Masking
None (Open Label)
Allocation
Randomized
Enrollment
50 (Anticipated)

8. Arms, Groups, and Interventions

Arm Title
Rivoroxaban
Arm Type
Experimental
Arm Description
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.
Arm Title
warfarin
Arm Type
Active Comparator
Arm Description
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
Intervention Type
Drug
Intervention Name(s)
Rivaroxaban
Other Intervention Name(s)
Xarelto
Intervention Description
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.
Intervention Type
Drug
Intervention Name(s)
Warfarin
Other Intervention Name(s)
Coumadin
Intervention Description
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.
Primary Outcome Measure Information:
Title
Modified Rankin Scale
Description
based on disability grade(0-6). 0 indicate patients have no disability and the worst score is 6.
Time Frame
3 months
Secondary Outcome Measure Information:
Title
hemorrhagic rate
Description
based on repeat MRI
Time Frame
3 months
Title
Stroke
Description
based on MRI
Time Frame
3 months

10. Eligibility

Sex
All
Minimum Age & Unit of Time
18 Years
Accepts Healthy Volunteers
No
Eligibility Criteria
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
Central Contact Person:
First Name & Middle Initial & Last Name or Official Title & Degree
Mohammad Javad Farajpour Khanaposhtani, MD
Phone
00989193967294
Email
mjf.khp@gmail.com
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Mohammad Saadatnia, Prof
Organizational Affiliation
Isfahan University of Medical Sciences
Official's Role
Principal Investigator
Facility Information:
Facility Name
Alzahra University Hospital
City
Isfahan
ZIP/Postal Code
8174673461
Country
Iran, Islamic Republic of
Individual Site Status
Recruiting
Facility Contact:
First Name & Middle Initial & Last Name & Degree
Mohammad Saadatnia, Prof
Phone
9131147179
Ext
98
Email
mosaadatnia@yahoo.com

12. IPD Sharing Statement

Plan to Share IPD
No
Citations:
PubMed Identifier
21830957
Citation
Patel MR, Mahaffey KW, Garg J, Pan G, Singer DE, Hacke W, Breithardt G, Halperin JL, Hankey GJ, Piccini JP, Becker RC, Nessel CC, Paolini JF, Berkowitz SD, Fox KA, Califf RM; ROCKET AF Investigators. Rivaroxaban versus warfarin in nonvalvular atrial fibrillation. N Engl J Med. 2011 Sep 8;365(10):883-91. doi: 10.1056/NEJMoa1009638. Epub 2011 Aug 10.
Results Reference
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Efficacy Comparison of Warfarin Versus Rivaroxaban CVT

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