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Statins Study in Children of Acute Kawasaki Disease With Coronary Artery Abnormalities

RecruitingPhase 3Ages 2 Years - 18 YearsAllChildren's Hospital of Fudan University
NCT07530640 on ClinicalTrials.gov ↗
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In plain words

What the trial is, and whether it could suit you

The goal of this observational study is to learn about the safety and effects of atorvastatin in treatment of Chinese Kawasaki disease (KD) children complicated with coronary artery abnormalities (CAA) in acute phase. The main questions it aims to answer are: Is atorvastatin safe in Chinese children of acute KD? Does atorvastatin contribute to control the acute inflammation in KD and improve the CAA?

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📋 Eligibility rules (as published)
Inclusion Criteria: * KD complicated with CAA, less than 20 days after the onset of KD, or more than 20 days after onset but the KD inflammation has not been controled. * IVIG and/or other anti-inflammatory treatments have been used/are being used. * The guardians agree to atorvastatin treatment and sign the informed consent form. Exclusion Criteria: * Patients with history of family hypercholesterolemia/taking statins/severe chronic diseases. * Patients with abnormal laboratory data including CK≥500U/L, total cholesterol\<3.1mmol/L, ALT or AST≥ 2 times the upper limit of normal. * The guardians do not agree to atorvastatin treatment.
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What it tests

  • atorvastatin of dose level 1
  • atorvastatin of dose level 2
  • atorvastatin of dose level 3
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Where

1 site
Children's Hospital of Fudan University
Shanghai, China
🤝 Taking part is your choice, and you can leave at any time. Only the trial team can confirm you are eligible — always decide together with your own doctor.
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