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

NCT01431105 | Completed Phase 1 Results DMC

• 1 other identifier: KD-Atorvastatin
• Study Type: interventional
• Target: 34
• Locations: 1 country
• Sites: 1

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.

Conditions

Kawasaki Disease

Keywords

Kawasaki disease

Outcome Measures

Primary Outcomes (1)

• Number of Participants With SAE

  Number of participants who experienced an SAE within the 6 week study period

  At 6 weeks after initiation of study drug

Study Arms (1)

Atorvasatin

EXPERIMENTAL

Atorvastatin dose titration to maximum tolerated dose

Drug: Atorvastatin

Interventions

Atorvastatin DRUG

Atorvastatin dose titration to maximum tolerated dose (once daily for 6 weeks)

Also known as: Lipitor

Atorvasatin

Eligibility Criteria

• Age: 2 Years - 17 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Child (0-17)

You may qualify if:

• Age ≥ 2 years to 17 years old
• Meets clinical criteria for KD according to American Heart Association guidelines (Table 2): Fever (T≥38oC or 100.4oC) ≥ 3 days and ≥ 2 clinical criteria with left anterior descending coronary artery/right coronary artery z-score ≥ 2.5 or an aneurysm (≥ 1.5 x the adjacent segment) of one of the coronary arteries
• Patient presents within the first 20 days after fever onset
• Parent or legal guardian able and willing to provide informed consent and subject willing and able to provide assent when appropriate.
• Post-menarchal females: Negative pregnancy test at screening and willing to use two forms of contraception during the study
• Males engaging in sexual activity that could lead to pregnancy must use a condom.

You may not qualify if:

• Use of a statin, fibrate, or niacin within the 3 months prior to enrollment
• Have any chronic disease, except asthma, atopic dermatitis, autism or controlled seizure disorder
• Screening creatine phosphokinase (CK) ≥ 3x upper limit of normal for age
• Patient taking a CYP3A4 inhibitor (ie. cyclosporine or clarithromycin) in the last 7 days
• Patient has a history of allergy to atorvastatin or its derivatives

Sponsors & Collaborators

• University of California, San Diego: lead
• Children's Hospital Colorado: collaborator
• University of Colorado, Denver: collaborator

Study Sites (1)

University of California San Diego

San Diego, California, 92093, United States

Location

Related Publications (1)

• He M, Chen Z, Martin M, Zhang J, Sangwung P, Woo B, Tremoulet AH, Shimizu C, Jain MK, Burns JC, Shyy JY. miR-483 Targeting of CTGF Suppresses Endothelial-to-Mesenchymal Transition: Therapeutic Implications in Kawasaki Disease. Circ Res. 2017 Jan 20;120(2):354-365. doi: 10.1161/CIRCRESAHA.116.310233. Epub 2016 Dec 6.

  PMID: 27923814 DERIVED

MeSH Terms

Conditions

Mucocutaneous Lymph Node Syndrome

Interventions

Atorvastatin

Condition Hierarchy (Ancestors)

Vasculitis; Vascular Diseases; Cardiovascular Diseases; Lymphatic Diseases; Hemic and Lymphatic Diseases; Skin Diseases, Vascular; Skin Diseases; Skin and Connective Tissue Diseases

Intervention Hierarchy (Ancestors)

Pyrroles; Azoles; Heterocyclic Compounds, 1-Ring; Heterocyclic Compounds; Heptanoic Acids; Fatty Acids; Lipids

Results Point of Contact

• Title: Adriana Tremoulet
• Organization: UC San Diego

atremoulet@ucsd.edu

858-246-0012

Study Officials

• Jane C Burns, MD

  University of California, San Diego

  PRINCIPAL INVESTIGATOR

Publication Agreements

• PI is Sponsor Employee: No
• Restrictive Agreement: No

Study Design

• Study Type: interventional
• Phase: phase 1
• Allocation: NA
• Masking: NONE
• Purpose: TREATMENT
• Intervention Model: SINGLE GROUP
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Chief, Division of Allergy, Immunology, Rheumatology

Study Record Dates

• First Submitted: September 6, 2011
• First Posted: September 9, 2011
• Study Start: July 1, 2012
• Primary Completion: January 1, 2018
• Study Completion: July 1, 2018
• Last Updated: May 6, 2020
• Results First Posted: June 4, 2019

Record last verified: 2020-05

Locations

US (1)