Atorvastatin in Infants and Children with Coronary Artery Abnormalities in Acute Kawasaki Disease

Phase 1

• Conditions: Kawasaki Disease; Mucocutaneous Lymph Node Syndrome

• Registration Number: JPRN-jRCTs031180057
• Lead Sponsor: Kobayashi Tohru

Brief Summary

In conclusion, the present study has determined a range of safe atorvastatin dosages for Japanese children with acute KD and CAA. Due to its lipid-lowering and potential anti-inflammatory and immunomodulatory actions, the addition of atorvastatin to the standard therapy of children with early signs of coronary artery injury may be advantageous in preventing the progression or inducing regression of CAA.

Detailed Description

Not available

Study Timeline

• Results First Posted: 1900-01-01
• Study Start: 2018-12-19
• Study Completion: 2022-03-01
• Last Update Posted: 17 October 2023

Recruitment & Eligibility

• Status: Complete
• Sex: All
• Target Recruitment: 9

Inclusion Criteria

1) Patienbts aged 2 to 17 years old
2) Meets clinical criteria for KD according to AHA guidelines and clinical criteria with LAD/RCA z-score 2.5
and over or an aneurysm of one of the coronary arteries
3) Patient presents within the first 20 days after fever onset
4) Parent or legal guardian able and willing to provide informed consent and subject willing and able to
provide assent when appropriate

Exclusion Criteria

1) Use of a statin, fibrate, or niacin within the 3 months prior to enrollment
2) Have any chronic disease, except asthma, atopic dermatitis, autism or controlled seizure disorder
3) Screening creatine phosphokinase (CK) more than 3 times upper limit of normal for age
4) Screening total cholesterol 99mg/dL and under
5) Screening AST or ALT 76IU/L and over
6) Patient taking a CYP3A4 inhibitor (i.e. cyclosporine, clarithromycin or doxycycline) in the last 7 days
7) Patient has a history of allergy to atorvastatin or its derivatives
8) Pregnant, unwilling to practice contraception during the study, or lactating female

Study & Design

• Study Type: Interventional
• Study Design: Not specified

Primary Outcome Measures

Name	Time	Method
Safety of atorvastatin in the study population

Secondary Outcome Measures

Name	Time	Method
1.Pharmacokinetics of atorvastatin <br>2.Activity of atorvastatin