Statins Study in Children of Acute Kawasaki Disease With Coronary Artery Abnormalities
Trial statusRecruiting
Trial phasePhase 3
Trial typeInterventional
Biological sexAll
Age2-18
SponsorChildren's Hospital of Fudan University
About this trial
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
Qualifiers
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.
Disqualifiers
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.
Trial design
Treatments tested in this trial
- atorvastatin of dose level 1
- atorvastatin of dose level 2
- atorvastatin of dose level 3
Treatment groups
9 Participants
are divided into 4 treatment groupsSponsors and collaborators
Source ClinicalTrials.gov