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

Study Status: Recruiting
Recruit Status: Recruiting
Study Type: Interventional

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

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 Summary:
Sponsor: University of California, San Diego

Current Primary Outcome: Safety of atorvastatin in children with coronary artery abnormalities secondary to Kawasaki disease [ Time Frame: At 6 weeks after initiation of study drug ]

Evaluation of cholesterol, liver functions, and markers of myopathy at the above time points.


Original Primary Outcome: Same as current

Current Secondary Outcome:

  • Pharmacokinetics [ Time Frame: 0,1,2,6,12,24 hours at baseline; 2&6 weeks ]
    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 ]
    Measures of oxidative stress will be assessed at baseline, 2 weeks and 6 weeks after study enrollment.


Original Secondary Outcome:

Information By: University of California, San Diego

Dates:
Date Received: September 6, 2011
Date Started: July 2012
Date Completion: December 2018
Last Updated: October 25, 2016
Last Verified: October 2016