Clinical Trial Details
— Status: Completed
Administrative data
| NCT number |
NCT03915795 |
| Other study ID # |
Statins study in KD |
| Secondary ID |
|
| Status |
Completed |
| Phase |
|
| First received |
|
| Last updated |
|
| Start date |
August 20, 2019 |
| Est. completion date |
December 30, 2023 |
Study information
| Verified date |
February 2024 |
| Source |
Children's Hospital of Fudan University |
| Contact |
n/a |
| Is FDA regulated |
No |
| Health authority |
|
| Study type |
Observational
|
Clinical Trial Summary
The aim of this study is to investigate the effects of statins on chronic inflammation,
coronary artery abnormalities and clinical cardiac events in long-term KD children
complicated with severe coronary artery abnormalities, and the feasibility and safety of
statins in treatment of KD children.
Description:
Kawasaki disease (KD) is an acute self-limited vasculitis and occurs almost exclusively in
childhood. It predominantly affects medium-sized arteries, most commonly the coronary
arteries. Although the use of intravenous immunoglobulin (IVIG) has obviously decreased the
incidence of coronary arteries (CA) abnormalities, still a part of KD children occur CA
abnormalities, even medium, large or giant aneurysms. The coronary aneurysms can develop to
thrombus and arterial stenosis, which may cause severe cardiac events, for example,
myocardial infarction. It is the main cause of disability and death in KD children. Now KD
has been the leading cause of acquired heart disease in children.
Some studies found that ongoing vascular chronic inflammation and oxidative stress persisted
in the long-term KD vasculopathy. Endothelial dysfunction, increased stiffness, and
intima-media thickening have been noted in both affected coronary arteries and systemic
arteries. Statins (hydroxymethylglutaryl coenzyme-A reductase inhibitors) not only are a kind
of drug lowering low-density lipoprotein cholesterol, but also have been reported to have
potentially beneficial pleiotropic effects on inflammation, endothelial function, oxidative
stress, platelet aggregation, coagulation, and fibrinolysis. They have been the cornerstone
of therapy for the primary and secondary prevention of atherosclerotic cardiovascular events
in adults. In recently years, statins have been considered to be used in KD children with
coronary aneurysms. Several short-term small studies in such patients treated with statins
have shown reductions in high-sensitivity CRP, improved endothelial function and statins'
safety in children. The American Heart Association (AHA) scientific statement on KD published
in 2017 suggests that empirical treatment with low-dose statin may be considered for KD
patients with past or current aneurysms, regardless of age or sex.
However, the current clinical data about the use of statins in KD children is still very
rare. The published researches mainly focused on the endothelial function of peripheral
arteries but the effects of statins on CAs and cardiac events have not been included.
Therefore, more studies are needed to conform statins' feasibility and safety in children and
its clinical application value.
In this study, we will recruit KD children complicated with severe CA abnormalities. These
children will be given statins for one year besides other routine treatments. The coronary
assessments, clinical and laboratory indexes will be followed up to study the effects of
statins on long-term chronic inflammation, CA abnormalities and clinical cardiac events. At
the same time, the clinical and laboratory indexes correlated to the side-effects will be
monitored regularly to investigate the feasibility and safety of statins in KD children.
