Pharmacokinetics (PK)/Safety Study of Atorvastatin in Children With Kawasaki Disease and Coronary Artery Abnormalities

Phase 1

Completed

• Conditions: Kawasaki Disease
• Interventions: Drug: Atorvastatin

• Registration Number: NCT01431105
• Lead Sponsor: University of California, San Diego

Brief Summary

Kawasaki disease (KD) is the leading cause of acquired heart disease in children in the developed world. Despite available treatment, 25% of children in San Diego County appropriately treated for KD develop coronary artery abnormalities that could lead to complications later in life, including heart attack. Although investigators can identify children with KD that have these coronary artery abnormalities, there is no approved additional treatment to decrease coronary artery inflammation and arrest or prevent damage to the coronary arteries. Inflammation and damage to the arterial wall is central to these coronary artery abnormalities. Statins, a class of drugs that is known for lowering cholesterol, have also been shown to decrease inflammation in general as well as at the level of the vessel wall. Therefore, the investigators propose to study the safety of the drug atorvastatin in children with coronary artery abnormalities from KD.

Detailed Description

Not available

Study Timeline

• Study First Submitted: 2011-09-06
• Study First Submitted QC: 2011-09-08
• Study First Posted: 2011-09-09
• Study Start: 2012-07
• Primary Completion: 2018-01
• Study Completion: 2018-07
• Results First Submitted: 2019-04-01
• Results First Submitted QC: 2019-05-11
• Results First Posted: 2019-06-04
• Status Verified: 2020-05
• Last Update Submitted: 2020-05-04
• Last Update Posted: 2020-05-06

Recruitment & Eligibility

• Status: COMPLETED
• Sex: All
• Target Recruitment: 34

Inclusion Criteria

Not provided

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) ≥ 3x upper limit of normal for age
4. Patient taking a CYP3A4 inhibitor (ie. cyclosporine or clarithromycin) in the last 7 days
5. Patient has a history of allergy to atorvastatin or its derivatives

Study & Design

• Study Type: INTERVENTIONAL
• Study Design: SINGLE_GROUP

Arm && Interventions

Group	Intervention	Description
Atorvasatin	Atorvastatin	Atorvastatin dose titration to maximum tolerated dose

Primary Outcome Measures

Name	Time	Method
Number of Participants With SAE	At 6 weeks after initiation of study drug	Number of participants who experienced an SAE within the 6 week study period

Trial Locations

Locations (1)

University of California San Diego; 🇺🇸 San Diego, California, United States