RecruitingPhase 3NCT07530640

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

Clinical Study of Atorvastatin in the Treatment of Acute Kawasaki Disease Complicated With Coronary Artery Abnormalities in Children

Sponsor

Children's Hospital of Fudan University

Enrollment

9 participants

Start Date

Jun 8, 2026

Study Type

INTERVENTIONAL

Conditions

Kawasaki Disease Coronary Artery Abnormalities

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

Min Age: 2 YearsMax Age: 18 Years

Plain Language Summary

Simplified for easier understanding

This clinical trial is studying a drug called atorvastatin of dose level 1, a drug called atorvastatin of dose level 2, and others for people with coronary artery abnormalities and kawasaki disease. The study is currently recruiting participants at 1 location. People eligible for this study include aged 2 Years to 18 Years.

This summary was AI-generated to explain the trial in plain language. It is not medical advice. Always discuss eligibility with your doctor before enrolling in a clinical trial.

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Interventions

DRUGatorvastatin 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).

DRUGatorvastatin of dose level 2

DRUGatorvastatin of dose level 3