NCT07530640 Statins Study in Children of Acute Kawasaki Disease With Coronary Artery Abnormalities
| NCT ID | NCT07530640 |
| Status | Recruiting |
| Phase | Phase 3 |
| Sponsor | Children's Hospital of Fudan University |
| Condition | Kawasaki Disease |
| Study Type | INTERVENTIONAL |
| Enrollment | 9 participants |
| Start Date | 2026-06-08 |
| Primary Completion | 2027-08-31 |
Eligibility & Interventions
Eligibility Fast-Check
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What to Expect as a Participant
You will actively receive the study intervention — which may be a drug, biologic, device, or procedure.
Phase 3 trials are large pivotal studies comparing the treatment to current standard of care or placebo. Your participation directly contributes to the evidence needed for regulatory approval.
This trial targets 9 participants in total. It began in 2026-06-08 with a primary completion date of 2027-08-31.
⚠ This information is for research awareness only. Always consult your physician before joining any clinical trial. Participation is voluntary and you may withdraw at any time.
Brief 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 Criteria
Inclusion Criteria: * 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. Exclusion Criteria: * Patients with history of family hypercholesterolemia/taking statins/severe chronic diseases. * Patients with abnormal laboratory data including CK≥500U/L, total cholesterol\<3.1mmol/L, ALT or AST≥ 2 times the upper limit of normal. * The guardians do not agree to atorvastatin treatment.
Contact & Investigator
Chen Chu, MD
STUDY DIRECTOR
Children's Hospital of Fudan University
Frequently Asked Questions
Who can join the NCT07530640 clinical trial?
This trial is open to participants of all sexes, aged 2 Years or older, up to 18 Years, studying Kawasaki Disease. Full inclusion and exclusion criteria are listed in the Eligibility Criteria section. Always confirm your eligibility with the research team before applying.
What phase is the NCT07530640 trial and what does that mean for participants?
Phase 3 trials are large-scale studies comparing the new treatment to existing standards of care or a placebo. They provide the evidence needed for regulatory approval. This trial targets 9 participants.
Is NCT07530640 currently recruiting?
Yes, NCT07530640 is actively recruiting participants. Contact the research team at chickenchu@163.com for enrollment information.
Where is the NCT07530640 trial being conducted?
This trial is being conducted at Shanghai, China.
Who is sponsoring the NCT07530640 clinical trial?
NCT07530640 is sponsored by Children's Hospital of Fudan University. The principal investigator is Chen Chu, MD at Children's Hospital of Fudan University. The trial plans to enroll 9 participants.