Clinical Trial

Model-informed Dose Optimization for Rivaroxaban in Children With Giant Coronary Artery Aneurysm After Kawasaki Disease

Recruiting Phase 4
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Record status
This record was last updated September 8, 2025 (before its estimated December 31, 2025 completion). Its status may not reflect the trial's current state.
Summary
Based on a population pharmacokinetic model-based dose optimization study, a 15 mg-equivalent, age-, and bodyweight-adjusted dosing regimen for Chinese children with giant coronary artery aneurysms after Kawasaki disease was proposed. This single-center, single-arm, pilot study aims to evaluate the feasibility of the 15 mg-equivalent dosing regimen within a limited sample size. Patients will be followed for more than 6 months. Clinical outcomes, including coronary artery thrombosis, major adverse cardiovascular events, and bleeding events, will be recorded. Rivaroxaban levels will be measured to assess the robustness of the model-informed dose optimization.
Protocol Amendment History 2 amendments
This ClinicalTrials.gov record has been amended 2 times since 2025-05-11; most recent amendment 2025-09-01.
Trial Details
NCT Number NCT06978439
Lead Sponsor Children's Hospital of Fudan University
Conditions Kawasaki Disease, Pilot Study, Coronary Artery Aneurysm, Rivaroxaban
Enrollment 10 participants
Start Date 2024-01-10
Primary Completion 2025-12-31 (estimated)
Study Completion 2025-12-31 (estimated)
Updated on ClinicalTrials.gov 2025-09-08