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
This trial does not accept healthy volunteersQualifiers
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
Design model
Parallel
Treatments tested in this trial
atorvastatin of dose level 1
DrugThe 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 2
DrugThe 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 3
DrugThe 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).
Treatment groups
9 Participants
are divided into 4 treatment groupsGroup A: statin group-level 1Experimental treatment 1 intervention
Group B: statin group-level 2Experimental treatment 1 intervention
Group C: statin group-level 3Experimental treatment 1 intervention
Group D: Control groupNo intervention 0 interventions
Trial outcomes
Primary outcomes
1
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.
Time frame
Before, 2 weeks and 6 weeks after taking atorvastatinSecondary outcomes
1
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
Time frame
Before, 1 week, 2 weeks and 6 weeks after taking atorvastatin2
Change of levels of serum amyloid A(SAA)
Change of levels of serum amyloid A(SAA) which reflex the acute KD inflammation
Time frame
Before, 1 week, 2 weeks and 6 weeks after taking atorvastatin3
Change of levels of interleukin-6 (IL-6)
Change of levels of interleukin-6 (IL-6) which reflex the acute KD inflammation
Time frame
Before, 1 week, 2 weeks and 6 weeks after taking atorvastatin4
Change of levels of NT-proBNP
Change of levels of NT-proBNP which reflex the acute KD inflammation
Time frame
Before, 2 weeks and 6 weeks after taking atorvastatinSponsors and contacts
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Source ClinicalTrials.gov