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

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?

Study Overview

• Status: Recruiting
• Conditions: Kawasaki Disease; Coronary Artery Abnormalities
• Intervention / Treatment: Drug: atorvastatin of dose level 1; Drug: atorvastatin of dose level 2; Drug: atorvastatin of dose level 3

Detailed Description

Kawasaki disease (KD) is acute self-limited vasculitis and occurs almost exclusively in childhood. It predominantly affects medium-sized arteries, most commonly coronary arteries. Although the use of intravenous immunoglobulin (IVIG) has obviously decreased the incidence of coronary arteries abnormalities (CAA), still a part of KD children occurs CAA, even medium, large or giant CA aneurysms. Coronary aneurysms can develop thrombus and arterial stenosis, which may cause severe cardiac events. Now KD has been the main cause of acquired heart disease in children in most areas of China mainland.

Studies have found that during the acute phase of KD, necrotizing arteritis occurs in coronary arteries. Oxidative stress, immune activation, and cellular infiltration of the vessel wall associated with secretion of proinflammatory cytokines, elastases, and matrix metalloproteinases (MMPs) are related to formation of coronary aneurysms. In addition, long-term KD vasculopathy appears ongoing vascular chronic inflammation and oxidative stress. Endothelial dysfunction, increased stiffness, and intima-media thickening have been noted in affected coronary arteries.

Statins, a hydroxymethylglutaryl coenzyme-A reductase inhibitors, has been widely used in adults for years not only for its reducing plasma cholesterol but also for its beneficial pleiotropic effects, including inflammation modulation, oxidative stress, endothelial function and angiogenesis, antithrombotic and antiplatelet effects. In recent years, statins have been considered to be used in KD children with coronary aneurysms. Several studies have shown reductions in high-sensitivity CRP, improved endothelial function and safety in such KD children treated with statins. The 2017 American Heart Association (AHA) scientific statement on KD has suggested that empirical treatment with low-dose statin may be considered for KD patients with past or current aneurysms, regardless of age or sex. The investigators have also conducted a follow-up study of atorvastatin used in long-term treatment of KD children with severe CAA. The results showed that long-term atorvastatin treatment was safe in Chinese KD children with CAA, but its dose was significantly lower than those been reported by previous studies abroad.

Based on the effects of statins on inhibition of MMP secretion and myofibroblast transformation which may anticipate the formation of CAA in acute KD, statins have been tried to be used in acute KD children with CAA. However, the relevant clinical data is very rare.Is atorvastatin safe in Chinese children of acute KD? Can atorvastatin actually contribute to control the acute inflammation of KD and improve CAA? The goal of this study is to learn about the safety and effects of atorvastatin in treatment of Chinese KD children complicated with CAA in acute phase.

• Study Type: Interventional
• Enrollment (Estimated): 9
• Phase: Phase 3

Contacts and Locations

• Study Contact: Name: Chen Chu, MD; Phone Number: +86 21 64932026; Email: chickenchu@163.com
• Study Contact Backup: Name: Fang Liu, MD; Phone Number: +86 21 64932800; Email: liufang@fudan.edu.cn

Study Locations

• China
  • Shanghai, China, 201102
    • Recruiting
    • Children's Hospital of Fudan University
    • Contact: Chen Chu, MD; Phone Number: +86 21 64932026; Email: chickenchu@163.com
    • Contact: Fang Liu, MD; Phone Number: +86 21 64932800; Email: liufang@fudan.edu.cn

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: Child; Adult
• Accepts Healthy Volunteers: No

Study Population

Acute KD children complicated with CAA admitted to Cardiology ward in Children's Hospital of Fudan University, Shanghai, China

Description

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.

Study Plan

How is the study designed?

Design Details

• Primary Purpose: Treatment
• Allocation: Non-Randomized
• Interventional Model: Parallel Assignment
• Masking: None (Open Label)

Number of Arms

4

Arms and Interventions

Participant Group / Arm	Intervention / Treatment
Experimental: statin group-level 1; Participants will receive atorvastatin of dose level 1 (0.15 mg/kg/day) for 6 weeks on the basis of conventional therapy.	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/kg/day; level 2, 0.25 mg/kg/day; level 3, 0.4 mg/kg/day). Participants will take atorvastatin for 6 weeks. The dose-limiting toxicities (DLTs) are used to determine the maximum tolerated dose (MTD).
Experimental: statin group-level 2; Participants will receive atorvastatin of dose level 2 (0.25 mg/kg/day) for 6 weeks on the basis of conventional therapy.	Drug: atorvastatin of dose level 2; 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/kg/day; level 2, 0.25 mg/kg/day; level 3, 0.4 mg/kg/day). Participants will take atorvastatin for 6 weeks. The dose-limiting toxicities (DLTs) are used to determine the maximum tolerated dose (MTD).
Experimental: statin group-level 3; Participants will receive atorvastatin of dose level 3 (0.4 mg/kg/day) for 6 weeks on the basis of conventional therapy.	Drug: atorvastatin of dose level 3; 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/kg/day; level 2, 0.25 mg/kg/day; level 3, 0.4 mg/kg/day). Participants will take atorvastatin for 6 weeks. The dose-limiting toxicities (DLTs) are used to determine the maximum tolerated dose (MTD).
No Intervention: Control group; Participants will only receive conventional therapy.

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
Incidence of statin-associated side effects in Chinese acute KD children with CAA	Safety evaluation of atorvastatin in acute KD children, referring to the incidence of statin-associated side effects (SASE). SASE include statin-associated clinical adverse events, elevated transaminase, creatine kinase, blood glucose and hypocholesterolemia.	Before, 2 weeks and 6 weeks after taking atorvastatin

Secondary Outcome Measures

Outcome Measure	Measure Description	Time Frame
Change of levels of high-sensitivity C reactive protein (sCRP)	Changes of levels of high-sensitivity C reactive protein (sCRP) which reflex the acute KD inflammation	Before, 1 week, 2 weeks and 6 weeks after taking atorvastatin
Change of levels of serum amyloid A(SAA)	Change of levels of serum amyloid A(SAA) which reflex the acute KD inflammation	Before, 1 week, 2 weeks and 6 weeks after taking atorvastatin
Change of levels of interleukin-6 (IL-6)	Change of levels of interleukin-6 (IL-6) which reflex the acute KD inflammation	Before, 1 week, 2 weeks and 6 weeks after taking atorvastatin
Change of levels of NT-proBNP	Change of levels of NT-proBNP which reflex the acute KD inflammation	Before, 2 weeks and 6 weeks after taking atorvastatin
Change of levels of albumin	Change of levels of albumin which reflex the acute KD inflammation	Before, 1 week, 2 weeks and 6 weeks after taking atorvastatin
Changes of sizes of involved coronary arteries measured by echocardiography	Changes of diameters of involved coronary artery aneurysms	Before, 2 weeks and 6 weeks after taking atorvastatin
Changes of diameter-Z score of involved coronary arteries measured by echocardiography	Changes of Z score of involved coronary artery aneurysms diameters	Before, 2 weeks and 6 weeks after taking atorvastatin
Changes of degrees of other echocardiographic findings	Changes of degrees of other echocardiographic findings which reflex the acute KD inflammation, including mitral regurgitation and pericardial effusion	Before, 2 weeks and 6 weeks after taking atorvastatin

Collaborators and Investigators

• Sponsor: Children's Hospital of Fudan University
• Investigators: Study Director: Chen Chu, MD, Children's Hospital of Fudan University

Study record dates

Study Major Dates

• Study Start (Actual): June 8, 2026
• Primary Completion (Estimated): August 31, 2027
• Study Completion (Estimated): September 30, 2027

Study Registration Dates

• First Submitted: March 24, 2026
• First Submitted That Met QC Criteria: April 8, 2026
• First Posted (Actual): April 15, 2026

Study Record Updates

• Last Update Posted (Actual): June 16, 2026
• Last Update Submitted That Met QC Criteria: June 14, 2026
• Last Verified: June 1, 2026

More Information

Terms related to this study

• Keywords: Atorvastatin; Acute; Kawasaki Disease; Coronary artery abnormalities
• Additional Relevant MeSH Terms: Vascular Diseases; Cardiovascular Diseases; Skin Diseases; Lymphatic Diseases; Skin Diseases, Vascular; Vasculitis; Skin and Connective Tissue Diseases; Hemic and Lymphatic Diseases; Mucocutaneous Lymph Node Syndrome
• Other Study ID Numbers: Statins study in acute KD; 2024ZZ2041 (Other Grant/Funding Number: New medical technology research and transformation seed program of Shanghai Municipal Health Commission, China)

Plan for Individual participant data (IPD)

• Plan to Share Individual Participant Data (IPD)?: NO

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: No
• Studies a U.S. FDA-regulated device product: No