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

Kawasaki Disease Clinical Trial

Official title:

Phase I/IIa Study of Pharmacokinetics and Safety of Atorvastatin in Children With Coronary Artery Abnormalities Secondary to Kawasaki Disease

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT01431105
• Other study ID #: KD-Atorvastatin
• Status: Completed
• Phase: Phase 1/Phase 2
• Start date: July 2012
• Est. completion date: July 2018

Study information

• Verified date: May 2020
• Source: University of California, San Diego
• Contact: n/a
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial 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.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 34
• Est. completion date: July 2018
• Est. primary completion date: January 2018
• Accepts healthy volunteers: No
• Gender: All
• Age group: 2 Years to 17 Years

Eligibility

Inclusion criteria:

1. Age = 2 years to 17 years old

2. 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

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.

5. Post-menarchal females: Negative pregnancy test at screening and willing to use two forms of contraception during the study

6. Males engaging in sexual activity that could lead to pregnancy must use a condom.

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

Related Conditions & MeSH terms

• Kawasaki Disease
• Mucocutaneous Lymph Node Syndrome

Intervention

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

Locations

Country	Name	City	State
United States	University of California San Diego	San Diego	California

Sponsors (3)

Lead Sponsor	Collaborator
University of California, San Diego	Children's Hospital Colorado, University of Colorado, Denver

Country where clinical trial is conducted

United States, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	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