NCT03747081

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.

Trial Health

43
At Risk

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Trial has exceeded expected completion date
Enrollment
50

participants targeted

Target at P50-P75 for phase_1

Timeline
Completed

Started Sep 2018

Geographic Reach
1 country

1 active site

Status
unknown

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

Study Start

First participant enrolled

September 1, 2018

Completed
2 months until next milestone

First Submitted

Initial submission to the registry

November 13, 2018

Completed
7 days until next milestone

First Posted

Study publicly available on registry

November 20, 2018

Completed
1.1 years until next milestone

Primary Completion

Last participant's last visit for primary outcome

January 1, 2020

Completed
4 months until next milestone

Study Completion

Last participant's last visit for all outcomes

May 1, 2020

Completed
Last Updated

November 20, 2018

Status Verified

November 1, 2018

Enrollment Period

1.3 years

First QC Date

November 13, 2018

Last Update Submit

November 17, 2018

Conditions

Cerebral Venous Thrombosis

Outcome Measures

Primary Outcomes (1)

  • Modified Rankin Scale

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

    3 months

Secondary Outcomes (2)

  • hemorrhagic rate

    3 months

  • Stroke

    3 months

Study Arms (2)

Rivoroxaban

EXPERIMENTAL

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

warfarin

ACTIVE COMPARATOR

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

Interventions

RivaroxabanDRUG

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.

Also known as: Xarelto
Rivoroxaban
WarfarinDRUG

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.

Also known as: Coumadin
warfarin

Eligibility Criteria

Age18 Years+
Sexall
Healthy VolunteersNo
Age GroupsAdult (18-64), Older Adult (65+)

You may qualify if:

  • Patients of both gender
  • Age 18 years and higher
  • proven CVT on neuro imaging ( MRI-MRV)

You may not qualify if:

  • 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

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

Alzahra University Hospital

Isfahan, 8174673461, Iran

RECRUITING

Related 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.

    PMID: 21830957BACKGROUND

MeSH Terms

Conditions

Intracranial Thrombosis

Interventions

RivaroxabanWarfarin

Condition Hierarchy (Ancestors)

Intracranial Embolism and ThrombosisCerebrovascular DisordersBrain DiseasesCentral Nervous System DiseasesNervous System DiseasesVascular DiseasesCardiovascular DiseasesThromboembolismEmbolism and Thrombosis

Intervention Hierarchy (Ancestors)

ThiophenesSulfur CompoundsOrganic ChemicalsMorpholinesOxazinesHeterocyclic Compounds, 1-RingHeterocyclic Compounds4-HydroxycoumarinsCoumarinsBenzopyransPyransHeterocyclic Compounds, 2-RingHeterocyclic Compounds, Fused-Ring

Study Officials

  • Mohammad Saadatnia, Prof

    Isfahan University of Medical Sciences

    PRINCIPAL INVESTIGATOR

Central Study Contacts

Mohammad Javad Farajpour Khanaposhtani, MD

CONTACT

00989193967294mjf.khp@gmail.com

Study Design

Study Type
interventional
Phase
phase 1
Allocation
RANDOMIZED
Masking
NONE
Purpose
TREATMENT
Intervention Model
PARALLEL
Sponsor Type
OTHER
Responsible Party
PRINCIPAL INVESTIGATOR
PI Title
Professor Mohammad Saadatnia

Study Record Dates

First Submitted

November 13, 2018

First Posted

November 20, 2018

Study Start

September 1, 2018

Primary Completion

January 1, 2020

Study Completion

May 1, 2020

Last Updated

November 20, 2018

Record last verified: 2018-11

Data Sharing

IPD Sharing
Will not share

Locations

IR(1)