Clinical Trial

Pharmacometrics Analysis of Rivaroxaban in Chinese Children Aged Over 2 Years

Recruiting
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Record status
This record was last updated May 29, 2025 (before its estimated December 31, 2025 completion). Its status may not reflect the trial's current state.
Summary
Based on an established Kawasaki disease cohort database, this prospective, single-center, single-arm, observational study will collect clinical data from children aged 2 years and older with giant coronary artery aneurysms after Kawasaki disease who received rivaroxaban treatment. Rivaroxaban plasma concentrations, anti-factor Xa activity levels, and genetic polymorphisms will be measured and analyzed to support the population pharmacokinetic/pharmacodynamic analysis
Trial Details
NCT Number NCT06993636
Lead Sponsor Children's Hospital of Fudan University
Conditions Kawasaki Disease, Coronary Artery Aneurysm, Rivaroxaban, Anticoagulant Drugs, Pharmacokinetics and Pharmacodynamics
Enrollment 60 participants
Start Date 2023-01-01
Primary Completion 2025-12-31 (estimated)
Study Completion 2026-12-31 (estimated)
Updated on ClinicalTrials.gov 2025-05-29