Statins Study in Children of Acute Kawasaki Disease With Coronary Artery Abnormalities (NCT07530640) | Clinical Trial Compass
RecruitingPhase 3
Statins Study in Children of Acute Kawasaki Disease With Coronary Artery Abnormalities
China9 participantsStarted 2026-06-08
Plain-language 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?
Who can participate
Age range
2 Years – 18 Years
Sex
ALL
See this in plain English?
AI-rewrites the medical criteria so a patient or caregiver can understand them. Always confirm with the trial site.
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.
Questions worth asking your doctor
Bring these to your next appointment. They're a starting point for a shared conversation — not a sign you qualify or a recommendation to enrol.
1Since this trial is specifically studying statin-associated side effects in Chinese children with acute Kawasaki disease and coronary artery abnormalities, is my child's background and diagnosis a close enough match to the population this study is designed for?
2This is a Phase 3 trial, which typically means the treatment has been tested in earlier phases — what do we already know about how statins have performed in children with Kawasaki disease so far, and what gaps is this study still trying to fill?
3The primary thing this trial is measuring is the incidence of side effects from statins — not just whether they work — so what kinds of side effects should we be watching for, and how would my child be monitored during the study?
4Are there standard treatment options already available for managing coronary artery abnormalities from Kawasaki disease that we should consider first before looking at a trial like this?
5Given that the trial is actively recruiting right now, what would participating actually look like for my child day-to-day — how many visits, how long would treatment last, and how would that fit into our family's life?
Generated to help you prepare — always confirm anything about your own eligibility and care with the study team and your doctor.
Questions for the trial coordinator
The trial coordinator is the person who runs the study day to day. These cover the practical side — logistics, costs, and what taking part would actually mean for your life. The study team confirms whether you meet the criteria; these are questions to ask, not a sign you qualify.
1What does taking part actually involve week to week — how many visits, where, and how long does each one take?
2What costs are covered by the study, and what might I have to pay for myself, including travel, parking, or time off work?
3What happens during screening, and what happens if the study team confirms I don't meet the criteria after those tests?
4Who pays for the scans, blood work, and other tests the trial requires — the study, my insurance, or me?
5How will being in the trial affect my regular care, and will my own doctor stay informed and involved?
6Can I leave the trial at any point if I change my mind, and what would happen to my care if I do?
A starting point for the conversation — always confirm anything about your own eligibility, costs, and care with the study team and your doctor.
What they're measuring
1
Incidence of statin-associated side effects in Chinese acute KD children with CAA
Timeframe: Before, 2 weeks and 6 weeks after taking atorvastatin