Clinical Trial

Rivaroxaban for Children Aged Over 2 Years With Giant Coronary Artery Aneurysms After Kawasaki Disease

Study acronym: RIVA-KG
Recruiting Phase 4
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Summary
Based on population pharmacokinetic model-based simulation, a 15 mg-equivalent, age-, and bodyweight-adjusted dosing regimen for Chinese children with giant coronary artery aneurysms after acute Kawasaki disease was proposed. This exploratory trial aims to evaluate the feasibility, safety and effectiveness of rivaroxaban compared to warfarin for thromboprophylaxis in children aged over 2 years with giant coronary artery aneurysms after Kawasaki disease
Protocol Amendment History 5 amendments
This ClinicalTrials.gov record has been amended 5 times since 2022-12-06; most recent amendment 2026-07-02.
Status change: Not Yet Recruiting → Recruiting 2025-06-29
Trial Details
NCT Number NCT05643651
Lead Sponsor Children's Hospital of Fudan University
Conditions Kawasaki Disease, Coronary Artery Aneurysm
Enrollment 100 participants
Start Date 2025-06-01
Primary Completion 2027-06-01 (estimated)
Study Completion 2027-09-01 (estimated)
Updated on ClinicalTrials.gov 2026-07-06