Atorvastatin in Chinese children with Kawasaki disease and coronary artery abnormalities

Is this trial a fit for you?

A plain-English reading of the study's rules. Only the study team can confirm whether you qualify.

What this trial studies

This Phase 3 interventional study evaluates the safety and potential benefits of atorvastatin in Chinese children with Kawasaki disease complicated by coronary artery abnormalities during the acute phase. Participants receive one of three dose levels of atorvastatin alongside standard treatments such as IVIG and anti-inflammatory therapy. The trial seeks to determine if atorvastatin can reduce inflammation and improve coronary artery damage while monitoring for adverse effects in this pediatric population. Eligibility includes recent KD with CAA and informed consent from guardians; key exclusions include certain chronic diseases and abnormal lab values. Conducted at the Children's Hospital of Fudan University, the study aims to clarify a potential new use of statins in this context.

Why it matters

Who can join: the full rules

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.

Where it's running

• Children's Hospital of Fudan University
  Shanghai, China Recruiting

Study contacts

• Study coordinator: Chen Chu, MD
• Email: chickenchu@163.com
• Phone: +86 21 64932026

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How to take part

1. Review the eligibility criteria above with your treating physician.
2. Check the official listing on ClinicalTrials.gov for the latest contact details and recruitment status.
3. Contact the study coordinator or principal investigator to ask for pre-screening. Pre-screening is free and never obligates you to enroll.