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Rivaroxaban for Children Aged Over 2 Years With Giant Coronary Artery Aneurysms After Kawasaki Disease
Sponsor: Children's Hospital of Fudan University
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
Official title: Rivaroxaban Versus Warfarin for Thromboprophylaxis in Children Aged Over 2 Years With Giant Coronary Artery Aneurysms After Kawasaki Disease: a Multicenter, Open-label, Parallel, Exploratory, Randomized Controlled Trial
Key Details
Gender
All
Age Range
2 Years - 18 Years
Study Type
INTERVENTIONAL
Enrollment
100
Start Date
2025-06-01
Completion Date
2027-09-01
Last Updated
2025-07-02
Healthy Volunteers
No
Conditions
Interventions
Rivaroxaban Oral Tablet [Xarelto]
Administered in an age- and bodyweight-adjusted, 15 mg-equivalent dose regimen proposed by model- and clinical evidence-informed precision dosing
Aspirin or Clopidogrel
Aspirin \[3 \~5mg/(kg·d) once daily\] or Clopidogrel \[1.0 mg/kg; once daily\]
Warfarin
Warfarin 0.05\~0.12 mg/(kg·d) once daily. INR should maintain within 1.5 to 2.5
Locations (1)
Children's Hospital of Fudan University
Shanghai, Shanghai Municipality, China