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

This study is currently recruiting participants.
Verified February 2013 by University of California, San Diego
Sponsor:
Collaborators:
Children's Hospital Colorado
University of Colorado, Denver
Information provided by (Responsible Party):
Jane C. Burns, University of California, San Diego
ClinicalTrials.gov Identifier:
NCT01431105
First received: September 6, 2011
Last updated: February 24, 2013
Last verified: February 2013

September 6, 2011
February 24, 2013
July 2012
June 2016   (final data collection date for primary outcome measure)
Safety of atorvastatin in children with coronary artery abnormalities secondary to Kawasaki disease [ Time Frame: At 6 weeks after initiation of study drug ] [ Designated as safety issue: Yes ]
Evaluation of cholesterol, liver functions, and markers of myopathy at the above time points.
Same as current
Complete list of historical versions of study NCT01431105 on ClinicalTrials.gov Archive Site
  • Pharmacokinetics [ Time Frame: 0,1,2,6,12,24 hours at baseline; 2&6 weeks ] [ Designated as safety issue: No ]
    Blood will be drawn around the first dose at 0,1,2,6,12 and 24 hours and troughs will be drawn at 2 weeks and 6 weeks during the clinic visit.
  • Atorvastatin Activity [ Time Frame: Baseline, 2 weeks and 6 weeks ] [ Designated as safety issue: No ]
    Measures of oxidative stress will be assessed at baseline, 2 weeks and 6 weeks after study enrollment.
Not Provided
Not Provided
Not Provided
 
Pharmacokinetics (PK)/Safety Study of Atorvastatin in Children With Kawasaki Disease and Coronary Artery Abnormalities
Phase I/IIa Study of Pharmacokinetics and Safety of Atorvastatin in Children With Coronary Artery Abnormalities Secondary to Kawasaki Disease

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.

Not Provided
Interventional
Phase 1
Phase 2
Endpoint Classification: Safety Study
Intervention Model: Single Group Assignment
Masking: Open Label
Primary Purpose: Treatment
Kawasaki Disease
Drug: Atorvastatin
Atorvastatin dose titration to maximum tolerated dose (once daily for 6 weeks)
Other Name: Lipitor
Experimental: Atorvasatin
Atorvastatin dose titration to maximum tolerated dose
Intervention: Drug: Atorvastatin
Not Provided

*   Includes publications given by the data provider as well as publications identified by ClinicalTrials.gov Identifier (NCT Number) in Medline.
 
Recruiting
32
December 2016
June 2016   (final data collection date for primary outcome measure)

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
Both
2 Years to 17 Years
No
Contact: Jane C Burns, MD 858-246-0155 jcburns@ucsd.edu
Contact: Adriana Tremoulet, MD, MAS 858-246-0012 atremoulet@ucsd.edu
United States
 
NCT01431105
KD-Atorvastatin
Yes
Jane C. Burns, University of California, San Diego
University of California, San Diego
  • Children's Hospital Colorado
  • University of Colorado, Denver
Principal Investigator: Jane C Burns, MD University of California, San Diego
University of California, San Diego
February 2013

ICMJE     Data element required by the International Committee of Medical Journal Editors and the World Health Organization ICTRP