[{"data":1,"prerenderedAt":-1},["ShallowReactive",2],{"health-study-detail:100633742":3},{"organization":4,"armGroups":7,"interventions":29,"overallOfficials":41,"centralContacts":45,"locations":54,"responsibleParty":70,"collaborators":28,"id":72,"slug":73,"hasResults":74,"nctId":75,"briefTitle":76,"officialTitle":77,"acronym":28,"eligibilityCriteria":78,"healthyVolunteers":74,"sex":79,"minAge":80,"maxAge":81,"enrollmentInfo":82,"targetDuration":28,"studyType":85,"phases":86,"briefSummary":88,"conditions":89,"keywords":92,"overallStatus":56,"whyStopped":28,"lastUpdateSubmitDate":96,"lastUpdatePostDateStruct":97,"startDateStruct":100,"completionDateStruct":102,"leadSponsor":104,"locationsCount":105},{"fullName":5,"class":6},"Children's Hospital of Fudan University","OTHER",[8,14,19,24],{"label":9,"type":10,"description":11,"interventionNames":12},"statin group-level 1","EXPERIMENTAL","Participants will receive atorvastatin of dose level 1 (0.15 mg\u002Fkg\u002Fday) for 6 weeks on the basis of conventional therapy.",[13],"Drug: atorvastatin of dose level 1",{"label":15,"type":10,"description":16,"interventionNames":17},"statin group-level 2","Participants will receive atorvastatin of dose level 2 (0.25 mg\u002Fkg\u002Fday) for 6 weeks on the basis of conventional therapy.",[18],"Drug: atorvastatin of dose level 2",{"label":20,"type":10,"description":21,"interventionNames":22},"statin group-level 3","Participants will receive atorvastatin of dose level 3 (0.4 mg\u002Fkg\u002Fday) for 6 weeks on the basis of conventional therapy.",[23],"Drug: atorvastatin of dose level 3",{"label":25,"type":26,"description":27,"interventionNames":28},"Control group","NO_INTERVENTION","Participants will only receive conventional therapy.",null,[30,35,38],{"type":31,"name":32,"description":33,"armGroupLabels":34,"otherNames":28},"DRUG","atorvastatin of dose level 1","The study is to be designed as dose-escalation protocol and enroll a minimum of 3 subjects per dose level (level 1, 0.15 mg\u002Fkg\u002Fday; level 2, 0.25 mg\u002Fkg\u002Fday; level 3, 0.4 mg\u002Fkg\u002Fday). Participants will take atorvastatin for 6 weeks. The dose-limiting toxicities (DLTs) are used to determine the maximum tolerated dose (MTD).",[9],{"type":31,"name":36,"description":33,"armGroupLabels":37,"otherNames":28},"atorvastatin of dose level 2",[15],{"type":31,"name":39,"description":33,"armGroupLabels":40,"otherNames":28},"atorvastatin of dose level 3",[20],[42],{"name":43,"affiliation":5,"role":44},"Chen Chu, MD","STUDY_DIRECTOR",[46,50],{"name":43,"role":47,"phone":48,"phoneExt":28,"email":49},"CONTACT","+86 21 64932026","chickenchu@163.com",{"name":51,"role":47,"phone":52,"phoneExt":28,"email":53},"Fang Liu, MD","+86 21 64932800","liufang@fudan.edu.cn",[55],{"facility":5,"status":56,"city":57,"state":28,"zip":58,"country":59,"countryCode":60,"cosmosGeoPoint":61,"geoPoint":66,"contacts":67},"RECRUITING","Shanghai","201102","China","CN",{"type":62,"coordinates":63},"Point",[64,65],121.45806,31.22222,{"lat":65,"lon":64},[68,69],{"name":43,"role":47,"phone":48,"phoneExt":28,"email":49},{"name":51,"role":47,"phone":52,"phoneExt":28,"email":53},{"type":71,"investigatorFullName":28,"investigatorTitle":28,"investigatorAffiliation":28,"oldNameTitle":28,"oldOrganization":28},"SPONSOR","100633742","phase-3-statins-study-in-children-of-acute-kawasaki-disease-with-coronary-artery-abnormalities-100633742",false,"NCT07530640","Statins Study in Children of Acute Kawasaki Disease With Coronary Artery Abnormalities","Clinical Study of Atorvastatin in the Treatment of Acute Kawasaki Disease Complicated With Coronary Artery Abnormalities in Children","Inclusion Criteria:\n\n* 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.\n* IVIG and\u002For other anti-inflammatory treatments have been used\u002Fare being used.\n* The guardians agree to atorvastatin treatment and sign the informed consent form.\n\nExclusion Criteria:\n\n* Patients with history of family hypercholesterolemia\u002Ftaking statins\u002Fsevere chronic diseases.\n* Patients with abnormal laboratory data including CK≥500U\u002FL, total cholesterol\\\u003C3.1mmol\u002FL, ALT or AST≥ 2 times the upper limit of normal.\n* The guardians do not agree to atorvastatin treatment.","ALL","2 Years","18 Years",{"count":83,"type":84},9,"ESTIMATED","INTERVENTIONAL",[87],"PHASE3","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?",[90,91],"Kawasaki Disease","Coronary Artery Abnormalities",[90,93,94,95],"Coronary artery abnormalities","Atorvastatin","Acute","2026-06-14",{"date":98,"type":99},"2026-06-16","ACTUAL",{"date":101,"type":99},"2026-06-08",{"date":103,"type":84},"2027-09-30",{"name":5,"class":6},1]