drugset / Trial / NCT07530640

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

NCT07530640

Phase 3 Recruiting 9 enrolled Children's Hospital of Fudan University
Non-randomizedParallel-groupOpen-labelTreatment

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?

Timeline

Start
2026-06-08
Primary completion
2027-08-31
Completion
2027-09-30

Drugs

EvaluationDrugModalityDoseRoute
Subject Atorvastatin Small molecule 0.15 mg/kg
Subject Atorvastatin Small molecule 0.25 mg/kg
Subject Atorvastatin Small molecule 0.4 mg/kg