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Trial record 23 of 734 for:    warfarin

Efficacy Comparison of Warfarin Versus Rivaroxaban CVT

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ClinicalTrials.gov Identifier: NCT03747081
Recruitment Status : Recruiting
First Posted : November 20, 2018
Last Update Posted : November 20, 2018
Sponsor:
Information provided by (Responsible Party):
Mohammad Saadatnia, Isfahan University of Medical Sciences

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.

Condition or disease Intervention/treatment Phase
Cerebral Venous Thrombosis Drug: Rivaroxaban Drug: Warfarin Phase 1 Phase 2

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Study Type : Interventional  (Clinical Trial)
Estimated Enrollment : 50 participants
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: None (Open Label)
Primary Purpose: Treatment
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

Resource links provided by the National Library of Medicine


Arm Intervention/treatment
Experimental: Rivoroxaban
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.
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.
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
Drug: 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.
Other Name: Coumadin




Primary Outcome Measures :
  1. 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.


Secondary Outcome Measures :
  1. hemorrhagic rate [ Time Frame: 3 months ]
    based on repeat MRI

  2. Stroke [ Time Frame: 3 months ]
    based on MRI



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Ages Eligible for Study:   18 Years and older   (Adult, Older Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No
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

Information from the National Library of Medicine

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


Contacts
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Contact: Mohammad Javad Farajpour Khanaposhtani, MD 00989193967294 mjf.khp@gmail.com

Locations
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Iran, Islamic Republic of
Alzahra University Hospital Recruiting
Isfahan, Iran, Islamic Republic of, 8174673461
Contact: Mohammad Saadatnia, Prof    9131147179 ext 98    mosaadatnia@yahoo.com   
Sponsors and Collaborators
Isfahan University of Medical Sciences
Investigators
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Principal Investigator: Mohammad Saadatnia, Prof Isfahan University of Medical Sciences

Publications:
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Responsible Party: Mohammad Saadatnia, Professor Mohammad Saadatnia, Isfahan University of Medical Sciences
ClinicalTrials.gov Identifier: NCT03747081     History of Changes
Other Study ID Numbers: Isfahan Stroke Unit
First Posted: November 20, 2018    Key Record Dates
Last Update Posted: November 20, 2018
Last Verified: November 2018
Individual Participant Data (IPD) Sharing Statement:
Plan to Share IPD: No

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Studies a U.S. FDA-regulated Drug Product: No
Studies a U.S. FDA-regulated Device Product: No
Additional relevant MeSH terms:
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Warfarin
Thrombosis
Venous Thrombosis
Embolism and Thrombosis
Vascular Diseases
Cardiovascular Diseases
Rivaroxaban
Anticoagulants
Factor Xa Inhibitors
Antithrombins
Serine Proteinase Inhibitors
Protease Inhibitors
Enzyme Inhibitors
Molecular Mechanisms of Pharmacological Action