Pharmacometrics Analysis of Rivaroxaban in Chinese Children Aged Over 2 Years
Recruiting
Observational Study
Kawasaki Disease
Coronary Artery Aneurysm
Rivaroxaban
Anticoagulant Drugs
Pharmacokinetics and Pharmacodynamics
No Placebo Group
Every participant receives an active treatment — no one gets a placebo.
No Study Drug
Researchers observe your health over time — no experimental treatment is given.
At a Glance
- Age
- 2 – 18
- Sex
- Any
- Study type
- Observational
- Participants needed
- 60 (estimated)
- Sponsor
- Children's Hospital of Fudan University · Other
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About This Trial
Based on an established Kawasaki disease cohort database, this prospective, single-center, single-arm, observational study will collect clinical data from children aged 2 years and older with giant coronary artery aneurysms after Kawasaki disease who received rivaroxaban treatment. Rivaroxaban plasma concentrations, anti-factor Xa activity levels, and genetic polymorphisms will be measured and ana…
Trial Locations
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Eligibility Criteria
Inclusion Criteria:
1. Giant coronary artery aneurysm(s) in any coronary artery after acute stage of Kawasaki disease. Giant coronary artery aneurysm(s) should be confirmed by two-dimensional echocardiography and meet the diagnostic criteria of Z-score ≥10 or coronary artery internal diameter ≥8mm;…
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