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

NCT07530640 · Status: RECRUITING · Phase: PHASE3 · Type: INTERVENTIONAL · Enrollment: 9

Last updated 2026-06-16

No results posted yet for this study

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?

Conditions

  • Kawasaki Disease
  • Coronary Artery Abnormalities

Interventions

DRUG

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).

DRUG

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).

DRUG

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).

Sponsors & Collaborators

  • Children's Hospital of Fudan University

    lead OTHER

Principal Investigators

  • Chen Chu, MD · Children's Hospital of Fudan University

Study Design

Allocation
NON_RANDOMIZED
Purpose
TREATMENT
Masking
NONE
Model
PARALLEL

Eligibility

Min Age
2 Years
Max Age
18 Years
Sex
ALL
Healthy Volunteers
No

Timeline & Regulatory

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

Countries

  • China

Study Locations

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Read the full study record

This page highlights key information. For complete eligibility criteria, study locations, investigator contacts, and the full protocol, visit the original record on ClinicalTrials.gov.

View NCT07530640 on ClinicalTrials.gov