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Statins Study in Children of Acute Kawasaki Disease With Coronary Artery Abnormalities
Sponsor: Children's Hospital of Fudan University
Summary
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?
Official title: Clinical Study of Atorvastatin in the Treatment of Acute Kawasaki Disease Complicated With Coronary Artery Abnormalities in Children
Key Details
Gender
All
Age Range
2 Years - 18 Years
Study Type
INTERVENTIONAL
Enrollment
9
Start Date
2026-06-08
Completion Date
2027-09-30
Last Updated
2026-06-16
Healthy Volunteers
No
Interventions
atorvastatin of dose level 1
The study is to be designed as dose-escalation protocol and enroll a minimum of 3 subjects per dose level (level 1, 0.15 mg/kg/day; level 2, 0.25 mg/kg/day; level 3, 0.4 mg/kg/day). Participants will take atorvastatin for 6 weeks. The dose-limiting toxicities (DLTs) are used to determine the maximum tolerated dose (MTD).
atorvastatin of dose level 2
The study is to be designed as dose-escalation protocol and enroll a minimum of 3 subjects per dose level (level 1, 0.15 mg/kg/day; level 2, 0.25 mg/kg/day; level 3, 0.4 mg/kg/day). Participants will take atorvastatin for 6 weeks. The dose-limiting toxicities (DLTs) are used to determine the maximum tolerated dose (MTD).
atorvastatin of dose level 3
The study is to be designed as dose-escalation protocol and enroll a minimum of 3 subjects per dose level (level 1, 0.15 mg/kg/day; level 2, 0.25 mg/kg/day; level 3, 0.4 mg/kg/day). Participants will take atorvastatin for 6 weeks. The dose-limiting toxicities (DLTs) are used to determine the maximum tolerated dose (MTD).
Locations (1)
Children's Hospital of Fudan University
Shanghai, China