Actively Recruiting
Model-informed Dose Optimization for Rivaroxaban in Children With Giant Coronary Artery Aneurysm After Kawasaki Disease
Led by Children's Hospital of Fudan University · Updated on 2025-09-08
10
Participants Needed
1
Research Sites
103 weeks
Total Duration
On this page
AI-Summary
What this Trial Is About
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.
CONDITIONS
Official Title
Model-informed Dose Optimization for Rivaroxaban in Children With Giant Coronary Artery Aneurysm After Kawasaki Disease
Who Can Participate
Eligibility Criteria
You may qualify if you...
- Children aged 1 month to under 18 years with bodyweight at least 2600g
- Confirmed giant coronary artery aneurysm(s) after acute Kawasaki disease by echocardiography (Z-score 6 10 or artery diameter 6 8mm)
- Recommended anticoagulant with antiplatelet drug therapy for thromboprophylaxis for the next 6 months
- Able to tolerate oral, nasogastric, or gastric feeding
You will not qualify if you...
- Active bleeding or bleeding risk contraindicating anticoagulant therapy
- History of venous thromboembolism or related risk factors like congenital heart disease, cancer, central venous catheter, or long-term immobilization
- Hypersensitivity or contraindications to study or comparator treatments
- Estimated glomerular filtration rate (eGFR) below 30 mL/min/1.73 m2 or, for children under 1 year, serum creatinine above 97.5th percentile
- Platelet count below 100 x 10^9/L
- Liver disease with coagulopathy or high liver enzyme/bilirubin levels
- Sustained uncontrolled hypertension above the 95th percentile for age
- Use of strong CYP3A4 and P-glycoprotein inhibitors or inducers (except fluconazole)
- Inability to cooperate with study procedures and follow-up visits
- 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, MD
CONTACT
How is the study designed?
Study Type
INTERVENTIONAL
Masking
NONE
Allocation
NA
Model
SINGLE_GROUP
Primary Purpose
PREVENTION
Number of Arms
1
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