Efficacy Comparison of Warfarin Versus Rivaroxaban CVT

Cerebral Venous Thrombosis Clinical Trial

Official title:

Comparing Treatment Outcomes in CVT Patients Who Treated With Warfarin and Rivaroxaban in Isfahan, Iran

Clinical Trial Details — Status: Recruiting

Administrative data

• NCT number: NCT03747081
• Other study ID #: Isfahan Stroke Unit
• Status: Recruiting
• Phase: Phase 1/Phase 2
• Start date: September 1, 2018
• Est. completion date: May 1, 2020

Study information

• Verified date: November 2018
• Source: Isfahan University of Medical Sciences
• Contact: Mohammad Javad Farajpour Khanaposhtani, MD
• Phone: 00989193967294
• Email: mjf.khp[@]gmail.com
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial 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.

Recruitment information / eligibility

• Status: Recruiting
• Enrollment: 50
• Est. completion date: May 1, 2020
• Est. primary completion date: January 1, 2020
• Accepts healthy volunteers: No
• Gender: All
• Age group: 18 Years and older

Eligibility

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

Related Conditions & MeSH terms

• Cerebral Venous Thrombosis
• Thrombosis
• Venous Thrombosis

Intervention

Drug:
• Rivaroxaban
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.
• Warfarin
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.

Locations

Country	Name	City	State
Iran, Islamic Republic of	Alzahra University Hospital	Isfahan

Sponsors (1)

Lead Sponsor	Collaborator
Isfahan University of Medical Sciences

Country where clinical trial is conducted

Iran, Islamic Republic of, 

References & Publications (1)

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. — View Citation

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Modified Rankin Scale	based on disability grade(0-6). 0 indicate patients have no disability and the worst score is 6.	3 months
Secondary	hemorrhagic rate	based on repeat MRI	3 months
Secondary	Stroke	based on MRI	3 months