Pilot Study of Atorvastatin and Anakinra in Children With Coronary Artery Abnormalities Secondary to Kawasaki Disease
Status:
Recruiting
Trial end date:
2024-04-01
Target enrollment:
Participant gender:
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 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.
Phase:
Early Phase 1
Details
Lead Sponsor:
University of California, San Diego
Collaborator:
National Heart, Lung, and Blood Institute (NHLBI)
Treatments:
Atorvastatin Interleukin 1 Receptor Antagonist Protein