drugset / Trial / NCT05643651
Rivaroxaban for Children Aged Over 2 Years With Giant Coronary Artery Aneurysms After Kawasaki Disease
RandomizedParallel-groupSingle-blindPrevention
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
Timeline
- Start
- 2025-06-01
- Primary completion
- 2027-06-01
- Completion
- 2027-09-01
Drugs
| Evaluation | Drug | Modality | Dose | Route |
|---|---|---|---|---|
| Subject | Rivaroxaban | Other / unclassified | 15 mg | Oral |
| Comparator | Warfarin | Small molecule | — | — |
| Background | Aspirin | Small molecule | — | — |
| Background | Clopidogrel | Small molecule | 1 mg/kg | — |