Statins Study in Children of Acute Kawasaki Disease With Coronary Artery Abnormalities

Condition(s) studied

Investigational drug(s) / intervention(s)

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).

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).

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).

Study 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?

Eligibility

Primary outcome measure(s)

• Incidence of statin-associated side effects in Chinese acute KD children with CAA — 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.

Trial sites (1)

More Children's Hospital of Fudan University trials in China

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