Actively Recruiting
Rivaroxaban for Children Aged Over 2 Years With Giant Coronary Artery Aneurysms After Kawasaki Disease
Led by Children's Hospital of Fudan University · Updated on 2025-07-02
100
Participants Needed
1
Research Sites
117 weeks
Total Duration
On this page
AI-Summary
What this Trial Is About
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
CONDITIONS
Official Title
Rivaroxaban for Children Aged Over 2 Years With Giant Coronary Artery Aneurysms After Kawasaki Disease
Who Can Participate
Eligibility Criteria
You may qualify if you...
- Children aged 2 years or older
- Diagnosed with giant coronary artery aneurysm(s) after acute Kawasaki disease confirmed by two-dimensional echocardiography with Z-score ≥10 or artery diameter ≥8mm
- Recommended to receive anticoagulant with antiplatelet therapy for thromboprophylaxis for the next 3 months
- Able to tolerate oral feeding, nasogastric, or gastric feeding
You will not qualify if you...
- Active bleeding or bleeding risk that contraindicates anticoagulant therapy
- History of venous thromboembolism or risk factors such as congenital heart disease, cancer, central venous catheter, or long-term immobilization
- Confirmed thrombus within giant coronary aneurysm by imaging
- Estimated glomerular filtration rate (eGFR) less than 30 mL/min/1.73 m2 or high serum creatinine in children under 1 year
- Platelet count below 100 x 10^9/L
- Liver disease with coagulopathy, or elevated liver enzymes (alanine aminotransferase > 5x upper limit) or bilirubin abnormalities
- Uncontrolled high blood pressure above 95th percentile for age
- Use of strong inhibitors of CYP3A4 and P-glycoprotein (certain HIV protease inhibitors and systemic azole-antimycotics except fluconazole)
- Use of strong inducers of CYP3A4 such as rifampicin, rifabutin, phenobarbital, phenytoin, or carbamazepine
- Allergic reaction or contraindications to study treatments
- Inability to cooperate with study procedures and follow-up
- Refusal to provide informed consent
AI-Screening
AI-Powered Screening
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Trial Site Locations
Total: 1 location
1
Children's Hospital of Fudan University
Shanghai, Shanghai Municipality, China, 201102
Actively Recruiting
Research Team
F
Fang Liu, MD
CONTACT
G
Guangan Dai
CONTACT
How is the study designed?
Study Type
INTERVENTIONAL
Masking
SINGLE
Allocation
RANDOMIZED
Model
PARALLEL
Primary Purpose
PREVENTION
Number of Arms
2
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