Clinical Study of Atorvastatin in the Treatment of Acute Kawasaki Disease Complicated With Coronary Artery Abnormalities in Children
Status: Recruiting
Location: See location...
Intervention Type: Drug
Study Type: Interventional
Study Phase: Phase 3
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?
Eligibility
Participation Requirements
Sex: All
Minimum Age: 2
Maximum Age: 18
Healthy Volunteers: f
View:
• 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.
Locations
Other Locations
China
Children's Hospital of Fudan University
RECRUITING
Shanghai
Contact Information
Primary
Chen Chu, MD
chickenchu@163.com
+86 21 64932026
Backup
Fang Liu, MD
liufang@fudan.edu.cn
+86 21 64932800
Time Frame
Start Date: 2026-06-08
Estimated Completion Date: 2027-09-30
Participants
Target number of participants: 9
Treatments
Experimental: statin group-level 1
Participants will receive atorvastatin of dose level 1 (0.15 mg/kg/day) for 6 weeks on the basis of conventional therapy.
Experimental: statin group-level 2
Participants will receive atorvastatin of dose level 2 (0.25 mg/kg/day) for 6 weeks on the basis of conventional therapy.
Experimental: statin group-level 3
Participants will receive atorvastatin of dose level 3 (0.4 mg/kg/day) for 6 weeks on the basis of conventional therapy.
No_intervention: Control group
Participants will only receive conventional therapy.
Related Therapeutic Areas
Sponsors
Leads: Children's Hospital of Fudan University