Kawasaki DiseasePhase 3NCT07530640
Statins Study in Children of Acute Kawasaki Disease With Coronary Artery Abnormalities
A Phase 3 study testing atorvastatin of dose level 1, atorvastatin of dose level 2 and atorvastatin of dose level 3 in people with Kawasaki Disease and Coronary Artery Abnormalities, run by Children's Hospital of Fudan University at 1 site in China.
Trial 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. Read more about this study
- Who is it for?
- Ages 2 to 18 years
- Conditions the study is for
- Kawasaki Disease, Coronary Artery Abnormalities
- What is being tested?
- atorvastatin of dose level 1, atorvastatin of dose level 2 and atorvastatin of dose level 3
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 9 participants
- Where
- 1 siteChina
- Study dates
- 8 Jun 2026to 30 Sep 2027
- Phase
- Phase 3
- Are there results?
- Not yet: the study is under way
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 2 to 18 years
- All sexes
- No healthy volunteers
- Child, Adult
Who may be able to join
- 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.
Who cannot join
- 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 locations and contacts
1 site in 1 country. Contact the study team or a site near you to ask about taking part.
China1 site, 1 recruiting
- Recruiting
Children's Hospital of Fudan University
Shanghai, 201102
Chen Chu, MD, +86 21 64932026, chickenchu@163.com
Fang Liu, MD, +86 21 64932800, liufang@fudan.edu.cn
About this study
Official title: 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?
Read the 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.
- Conditions
- Kawasaki Disease, Coronary Artery Abnormalities
- Being tested
- atorvastatin of dose level 1, atorvastatin of dose level 2, atorvastatin of dose level 3
- Keywords
- Kawasaki Disease, Coronary artery abnormalities, Atorvastatin, Acute
- Medical subject headings
- Mucocutaneous Lymph Node Syndrome
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
atorvastatin of dose level 1Drug
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).
atorvastatin of dose level 2Drug
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).
atorvastatin of dose level 3Drug
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).
| Study group | Role | What they receive |
|---|---|---|
| statin group-level 1 | Experimental | Participants will receive atorvastatin of dose level 1 (0.15 mg/kg/day) for 6 weeks on the basis of conventional therapy. Receives: Drug: atorvastatin of dose level 1 |
| statin group-level 2 | Experimental | Participants will receive atorvastatin of dose level 2 (0.25 mg/kg/day) for 6 weeks on the basis of conventional therapy. Receives: Drug: atorvastatin of dose level 2 |
| statin group-level 3 | Experimental | Participants will receive atorvastatin of dose level 3 (0.4 mg/kg/day) for 6 weeks on the basis of conventional therapy. Receives: Drug: atorvastatin of dose level 3 |
| Control group | No intervention | Participants will only receive conventional therapy. |
What is being measured
The primary outcome is the main question the study is designed to answer.
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.
Measured: Before, 2 weeks and 6 weeks after taking atorvastatin
Secondary outcomes (8)
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
Measured: 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
Measured: 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
Measured: 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
Measured: 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
Measured: 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
Measured: 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
Measured: 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
Measured: Before, 2 weeks and 6 weeks after taking atorvastatin
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted15 Apr 2026
- Study start8 Jun 2026
- Primary completion31 Aug 2027 (estimated)
- Study completion30 Sep 2027 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Kawasaki DiseaseStudies of the same condition, open and under way.
- More trials run by Children's Hospital of Fudan UniversityThe sponsor's other registered studies.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase 3
- Primary purpose
- Treatment
- Allocation
- Non-randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Enrolment
- 9 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Children's Hospital of Fudan University
- Sponsor type
- University, hospital or other
- Responsible party
- Sponsor
- Investigators
- Chen Chu, MD, Study director, Children's Hospital of Fudan University
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT07530640
- Sponsor's protocol ID
- Statins study in acute KD
- Other IDs
- 2024ZZ2041
- Status last verified
- Jun 2026
- First submitted
- 24 Mar 2026
- Last updated
- 16 Jun 2026
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No
Study at a glance
From the registry record, last updated by the sponsor on 16 Jun 2026. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Clinical Study of Atorvastatin in the Treatment of Acute Kawasaki Disease Complicated With Coronary Artery Abnormalities in Children
- ClinicalTrials.gov ID
- NCT07530640
- Acronym / sponsor ID
- Statins study in acute KD
- Conditions
- Kawasaki Disease, Coronary Artery Abnormalities
- Keywords
- Kawasaki Disease, Coronary artery abnormalities, Atorvastatin, Acute
- Phase
- Phase 3
- Study type
- Interventional
- Recruitment status
- Recruiting
- Enrolment
- 9 participants (estimated)
- Lead sponsor
- Children's Hospital of Fudan UniversityUniversity, hospital or other
- Study start
- 8 Jun 2026 (actual)
- Primary completion
- 31 Aug 2027 (estimated)
- Study completion
- 30 Sep 2027 (estimated)
- First posted
- 15 Apr 2026 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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?
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 design
- Primary purpose
- Treatment
- Allocation
- Non-randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Number of arms
- 4
| Arm | Type | Receives |
|---|---|---|
| statin group-level 1 | Experimental | Drug: atorvastatin of dose level 1Participants will receive atorvastatin of dose level 1 (0.15 mg/kg/day) for 6 weeks on the basis of conventional therapy. |
| statin group-level 2 | Experimental | Drug: atorvastatin of dose level 2Participants will receive atorvastatin of dose level 2 (0.25 mg/kg/day) for 6 weeks on the basis of conventional therapy. |
| statin group-level 3 | Experimental | Drug: atorvastatin of dose level 3Participants will receive atorvastatin of dose level 3 (0.4 mg/kg/day) for 6 weeks on the basis of conventional therapy. |
| Control group | No intervention | –Participants will only receive conventional therapy. |
Who may qualify
- Ages
- 2 to 18 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Child, Adult
Key inclusion criteria (3 listed)
- 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.
Key exclusion criteria (3 listed)
- 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.
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| atorvastatin of dose level 1The 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). | Drug | statin group-level 1 |
| atorvastatin of dose level 2The 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). | Drug | statin group-level 2 |
| atorvastatin of dose level 3The 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). | Drug | statin group-level 3 |
Primary outcome
Incidence of statin-associated side effects in Chinese acute KD children with CAA
Time frame: Before, 2 weeks and 6 weeks after taking atorvastatin
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.
8 secondary outcomes
Change of levels of high-sensitivity C reactive protein (sCRP)
Time frame: Before, 1 week, 2 weeks and 6 weeks after taking atorvastatin
Change of levels of serum amyloid A(SAA)
Time frame: Before, 1 week, 2 weeks and 6 weeks after taking atorvastatin
Change of levels of interleukin-6 (IL-6)
Time frame: Before, 1 week, 2 weeks and 6 weeks after taking atorvastatin
Change of levels of NT-proBNP
Time frame: Before, 2 weeks and 6 weeks after taking atorvastatin
Change of levels of albumin
Time frame: Before, 1 week, 2 weeks and 6 weeks after taking atorvastatin
Changes of sizes of involved coronary arteries measured by echocardiography
Time frame: Before, 2 weeks and 6 weeks after taking atorvastatin
Changes of diameter-Z score of involved coronary arteries measured by echocardiography
Time frame: Before, 2 weeks and 6 weeks after taking atorvastatin
Changes of degrees of other echocardiographic findings
Time frame: Before, 2 weeks and 6 weeks after taking atorvastatin
Results and safety
This study is still under way. Results are not available in the source record yet.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 16 Jun 2026.
- Individual participant dataSharing planned: No
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part.
Chen Chu, MD study director
Children's Hospital of Fudan University
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A Phase 3 study testing atorvastatin of dose level 1, atorvastatin of dose level 2 and atorvastatin of dose level 3 in people with Kawasaki Disease and Coronary Artery Abnormalities, run by Children's Hospital of Fudan University at 1 site in China.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 3 inclusion and 3 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: looking for participants now, as of the sponsor's last update on 16 Jun 2026. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in China. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
What does this phase mean?
Phase 3 studies compare the treatment with the current standard treatment or a placebo in a large group, to confirm how well it works and watch for side effects.
Not every study follows the same path, and some studies (observational studies, device studies) have no phase.
Are results available for this study?
This study is still under way. Results are not available in the source record yet.
How can a doctor refer a patient or contact the research team?
Contact Chen Chu, MD (+86 21 64932026, chickenchu@163.com), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Incidence of statin-associated side effects in Chinese acute KD children with CAA (time frame: Before, 2 weeks and 6 weeks after taking atorvastatin). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 16 Jun 2026.