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

RecruitingPhase 3

Sponsor: Children's Hospital of Fudan University

Conditions: Kawasaki Disease, Coronary Artery Abnormalities

Interventions: atorvastatin of dose level 1, atorvastatin of dose level 2, atorvastatin of dose level 3

Countries: China

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 overview

Sex: ALL

Age: 2 Years to 18 Years

Healthy volunteers: No

Study type: INTERVENTIONAL

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.

Locations (1)

Shanghai, China