Efficacy and Safety of Oral Rivaroxaban in Cerebrosinovenous Thrombosis

NCT07523347 | Completed

• 1 other identifier: Dr-Zia-ur-Rehaman-LHR
• Study Type: interventional
• Target: 75
• Locations: 1 country
• Sites: 1

Brief 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).

Conditions

Cerebrosinovenous Thrombosis

Outcome Measures

Primary Outcomes (1)

• Treatment efficacy

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

  3 months

Secondary Outcomes (2)

• Bleeding events

  3 months

• Prolonged International Normalized Ratio (INR)

  3 months

Study Arms (2)

Rivaroxaban-Group

EXPERIMENTAL

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

Drug: Rivaroxaban

Warfarin-Group

EXPERIMENTAL

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

Drug: Warfarin

Interventions

Rivaroxaban DRUG

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

Rivaroxaban-Group

Warfarin DRUG

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

Warfarin-Group

Eligibility Criteria

• Age: 2 Months - 18 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Child (0-17), Adult (18-64)

You may qualify if:

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

You may not qualify if:

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

Sponsors & Collaborators

• Muhammad Aamir Latif: lead

Study Sites (1)

The Children's Hospital

Lahore, Punjab Province, 54600, Pakistan

Location

MeSH Terms

Interventions

Rivaroxaban; Warfarin

Intervention Hierarchy (Ancestors)

Thiophenes; Sulfur Compounds; Organic Chemicals; Morpholines; Oxazines; Heterocyclic Compounds, 1-Ring; Heterocyclic Compounds; 4-Hydroxycoumarins; Coumarins; Benzopyrans; Pyrans; Heterocyclic Compounds, 2-Ring; Heterocyclic Compounds, Fused-Ring

Study Officials

• Muhammad Zia-Ur-Rehman, FCPS

  The Children's Hospital, Lahore, Pakistan

  PRINCIPAL INVESTIGATOR

• Muhammad Sohail, FCPS

  The Children's Hospital, Lahore

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: NONE
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: SPONSOR INVESTIGATOR
• PI Title: Research consultant

Study Record Dates

• First Submitted: April 4, 2026
• First Posted: April 13, 2026
• Study Start: December 1, 2023
• Primary Completion: December 31, 2025
• Study Completion: December 31, 2025
• Last Updated: April 13, 2026

Record last verified: 2026-03

Data Sharing

• IPD Sharing: Will not share

Locations

PA (1)