Atorvastatin + Anakinra for Kawasaki Disease
Trial Summary
What is the purpose of this trial?
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 we 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. 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. Anakinra, a therapy that blocks the high levels of interleukin 1 (IL1) that leads to inflammation during acute KD, has been shown in the KD mouse model to prevent the development of coronary artery damage. Both of these therapies have been demonstrated to be safe and well-tolerated in KD patients. Therefore, we propose to study the effects of combination therapy with atorvastatin and anakinra in children with acute KD and early coronary artery abnormalities.
Research Team
Adriana Tremoulet, MD
Principal Investigator
Professor
Eligibility Criteria
This trial is for children with Kawasaki Disease who have developed coronary artery abnormalities, specifically with a Z score of 3 or larger in certain arteries. Children cannot participate if they are taking drugs metabolized by the enzyme CYP3A4, like cyclosporine.Inclusion Criteria
Exclusion Criteria
Treatment Details
Interventions
- Atorvastatin and Anakinra
Find a Clinic Near You
Who Is Running the Clinical Trial?
University of California, San Diego
Lead Sponsor
National Heart, Lung, and Blood Institute (NHLBI)
Collaborator