NCT07523347

Efficacy and Safety of Oral Rivaroxaban in Cerebrosinovenous Thrombosis

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

• Status: Completed
• Phase: N/A
• Study type: Interventional
• Enrollment: 75 (actual)
• Sponsor: Muhammad Aamir Latif · Academic / Other
• Sex: All
• Age: 2 Months – 18 Years
• Healthy volunteers: Not accepted

Summary

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).

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.

Conditions

• Cerebrosinovenous Thrombosis

Interventions

Type	Name	Description
DRUG	Rivaroxaban	Children were treated initially with low molecular weight heparin (LMWH) for 7 to 10 days followed by oral rivaroxaban 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.

Timeline

• Start date: 2023-12-01
• Primary completion: 2025-12-31
• Completion: 2025-12-31
• First posted: 2026-04-13
• Last updated: 2026-04-13

Locations

1 site across 1 country: Pakistan