Efficacy Comparison of Warfarin Versus Rivaroxaban CVT

Isfahan University of Medical Sciences

Status and phase: Unknown; Phase 2; Phase 1

Conditions: Cerebral Venous Thrombosis

Treatments: Drug: Warfarin; Drug: Rivaroxaban

Study type: Interventional

Funder types: Other

Identifiers

NCT03747081

Isfahan Stroke Unit

Details and patient eligibility

About

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.

Enrollment: 50 estimated patients

Sex: All

Ages: 18+ years old

Volunteers: No Healthy Volunteers

Inclusion and exclusion 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

Trial design

Primary purpose: Treatment

Allocation: Randomized

Interventional model: Parallel Assignment

Masking: None (Open label)

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50 participants in 2 patient groups

Rivoroxaban

Experimental group

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.

Treatment:

Drug: Rivaroxaban

warfarin

Active Comparator group

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

Treatment:

Drug: Warfarin