Efficacy and Safety of Oral Rivaroxaban in Cerebrosinovenous Thrombosis

April 4, 2026 updated by: Muhammad Aamir Latif

To Determine the Safety and Efficacy of Oral Rivaroxaban and Standard Anticoagulant in the Treatment of Cerebrosinovenous Thrombosis in Children

The study seeks to fill the gaps regarding safety and efficacy of rivaroxaban and standard anticoagulant. therefore the current study was planned with the aim to determine the safety and efficacy of rivaroxaban and standard anticoagulant in the treatment of cerebrosinovenous thrombosis (CSVT).

Study Overview

Status

Completed

Conditions

Intervention / Treatment

Detailed Description

There have not been any randomized controlled trials in the country to demonstrate the efficacy, safety and outcome after the oral use of rivaroxaban in pediatric population and establish its protocol with body weight adjusted dosages in children. The findings of this study would not only add to the local data but also be of great interest to physicians and CSVT patients if an anticoagulant were found to have predictable effects and no need for therapeutic INR monitoring.

Study Type

Interventional

Enrollment (Actual)

75

Phase

  • Not Applicable

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Locations

  • Pakistan
    • Punjab Province
      • Lahore, Punjab Province, Pakistan, 54600
        • The Children's Hospital

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

  • Child
  • Adult

Accepts Healthy Volunteers

No

Description

Inclusion Criteria:

  • Any gender
  • Aged 2 months to 18 years
  • Patients presenting with CSVT evident by computed tomography (CT) or magnetic resonance venography (MRV).

Exclusion Criteria:

  • Patients having active bleeding or having high risk of bleeding
  • Estimated glomerular filtration rate < 30 milliliter/minute per 1.73 m2.

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

  • Primary Purpose: Treatment
  • Allocation: Randomized
  • Interventional Model: Parallel Assignment
  • Masking: None (Open Label)

Arms and Interventions

Participant Group / Arm
Intervention / Treatment
Experimental: Rivaroxaban-Group
Children were treated initially with low molecular weight heparin (LMWH) for 7 to 10 days followed by oral rivaroxaban for 3 months.
Drug: Rivaroxaban
Children were treated initially with low molecular weight heparin (LMWH) for 7 to 10 days followed by oral rivaroxaban for 3 months.
Experimental: Warfarin-Group
Children received initially low molecular weight heparin (LMWH) for 7 to 10 days followed by oral warfarin for 3 months.
Drug: Warfarin
Children received initially low molecular weight heparin (LMWH) for 7 to 10 days followed by oral warfarin for 3 months.

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Measure Description
Time Frame
Treatment efficacy
Time Frame: 3 months
Efficacy was considered "yes" if, after recanalization, the veins demonstrated normalization upon venography as compared to baseline.
3 months

Secondary Outcome Measures

Outcome Measure
Measure Description
Time Frame
Bleeding events
Time Frame: 3 months
The treatment was considered 'safe', if no any bleeding event occurred within the course of treatment.
3 months
Prolonged International Normalized Ratio (INR)
Time Frame: 3 months
The treatment was considered 'safe', if INR did not exceed 3.0.
3 months

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

Muhammad Aamir Latif

Investigators

  • Principal Investigator: Muhammad Zia-Ur-Rehman, FCPS, The Children's Hospital, Lahore, Pakistan
  • Principal Investigator: Muhammad Sohail, FCPS, The Children's Hospital, Lahore

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start (Actual)

December 1, 2023

Primary Completion (Actual)

December 31, 2025

Study Completion (Actual)

December 31, 2025

Study Registration Dates

First Submitted

April 4, 2026

First Submitted That Met QC Criteria

April 4, 2026

First Posted (Actual)

April 13, 2026

Study Record Updates

Last Update Posted (Actual)

April 13, 2026

Last Update Submitted That Met QC Criteria

April 4, 2026

Last Verified

March 1, 2026

More Information

Terms related to this study

Additional Relevant MeSH Terms

Other Study ID Numbers

  • Dr-Zia-ur-Rehaman-LHR

Plan for Individual participant data (IPD)

Plan to Share Individual Participant Data (IPD)?

NO

IPD Plan Description

Data can be shared on a reasonable request.

Drug and device information, study documents

Studies a U.S. FDA-regulated drug product

No

Studies a U.S. FDA-regulated device product

No

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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