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OpenTrials
Completed

NCT Number: NCT07523347

Efficacy and Safety of Oral Rivaroxaban in Cerebrosinovenous Thrombosis

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).

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Key information

Conditions

Cerebrosinovenous Thrombosis

Age range

2 month–18 year

Sex eligibility

All sexes

Study type

Interventional

Phase

Not applicable

Primary location

The Children's Hospital

Lahore, Punjab Province, 54600, Pakistan

About this study

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.

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

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.

Treatment and study plan

Rivaroxaban

Drug

Children were treated initially with low molecular weight heparin (LMWH) for 7 to 10 days followed by oral rivaroxaban for 3 months.

Warfarin

Drug

Children received initially low molecular weight heparin (LMWH) for 7 to 10 days followed by oral warfarin for 3 months.

Primary outcomes

  1. Treatment efficacy

    Time frame: 3 months

    Efficacy was considered "yes" if, after recanalization, the veins demonstrated normalization upon venography as compared to baseline.

Secondary outcomes

  1. Bleeding events

    Time frame: 3 months

    The treatment was considered 'safe', if no any bleeding event occurred within the course of treatment.

  2. Prolonged International Normalized Ratio (INR)

    Time frame: 3 months

    The treatment was considered 'safe', if INR did not exceed 3.0.

Sponsors and collaborators

Lead sponsor

Muhammad Aamir Latif

Other

Registry information

Official study title

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

Important dates

Study start
2023
Primary completion
2025
Study completion
2025
First posted
Apr 13, 2026
Registry last updated
Apr 13, 2026

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.