Kawasaki Disease Clinical Trial
Official title:
An Open Label, Non-comparative Phase II Trial to Evaluate the Effects of Atorvastatin on the Persistent Coronary Arterial Aneurysm in Children With Kawasaki Disease: Safety and Efficacy
Background Kawasaki disease (KD) is characterized by fever, bilateral nonexudative
conjunctivitis, erythema of the lips and oral mucosa, changes in the extremities, rash, and
cervical lymphadenopathy. Incidence of late coronary artery aneurysms or ectasia, which may
lead to myocardial infarction (MI), sudden death, or ischemic heart disease, decreased after
the introduction of intravenous immunoglobulin therapy. However, significant persistent
coronary arterial lesions or aneurysms may still occur in about 1-3 % of the patients.
Atorvastatin (Lipitor®), a kind of statin, is a selective competitive inhibitor of
3-hydroxy-3-methylglutaryl-coenzyme A (HMG-CoA) reductase. This drug had been safely and
widely used for treatment of adult hyperlipidemia, prevention of coronary heart disease and
familial hypercholesterolemia in childhood. In addition to the cholesterol-lowering effects,
statins exerts diverse cellular, cholesterol-independent effects, including improvement in
endothelial function, inhibition of neurohormonal activation, and reduction in levels of
proinflammatory cytokines. Based on the above concepts, some patients with infrarenal
abdominal aortic aneurysms received statin therapies and then the growth rate of aneurysms
slowed down.
Therefore, the investigators may hypothesize that Atorvastatin is helpful in the regression
of persistent coronary lesions in KD patients due to its effect of anti-inflammation. In
NTUH, there are about 20 KD patients with coronary lesions persistent for many years. And
the investigators plan to conduct the clinical trial with atorvastatin to evaluate the
effects of Atorvastatin on the persistent coronary arterial lesions/aneurysms in children
with Kawasaki disease including safety and efficacy.
Methods
There are around 20 KD patients eligible for this study. After they sign the IRB-approved
ICF, they will be enrolled for this study. Briefly, this study is divided into three stages:
screening & enrollment stage (I), treatment & follow-up stage (II) for 1 year and final data
analysis stage (III). Measurements include basic vital sign, electrocardiography, liver
function, muscle enzyme, inflammatory markers and echocardiography.
Predicted results
1.Oral atorvastatin therapy can effectively prevent the progression of coronary lesions in
KD patients.
Background Kawasaki disease (KD) is characterized by fever, bilateral nonexudative
conjunctivitis, erythema of the lips and oral mucosa, changes in the extremities, rash, and
cervical lymphadenopathy. Incidence of late coronary artery aneurysms or ectasia, which may
lead to myocardial infarction (MI), sudden death, or ischemic heart disease, decreased after
the introduction of intravenous immunoglobulin therapy. However, significant persistent
coronary arterial lesions or aneurysms may still occur in about 1-3 % of the patients.
Aspirin and warfarin, the recommended medication to prevent and decrease the incidence of
coronary artery events, can't guarantee the coronary patency in these KD patients. Thus,
it's urgent to look for an effective and safe treatment to make sure the coronary lesions
will stabilize even regress gradually.
Several groups studied the clinical characteristics of KD patients with coronary sequelae
and showed there was association between elevated inflammatory markers and the persistence
of coronary lesions. Atorvastatin (Lipitor®), a kind of statin, is a selective competitive
inhibitor of 3-hydroxy-3-methylglutaryl-coenzyme A (HMG-CoA) reductase. This drug had been
safely and widely used for treatment of adult hyperlipidemia, prevention of coronary heart
disease and familial hypercholesterolemia in childhood. In addition to the
cholesterol-lowering effects, statins exerts diverse cellular, cholesterol-independent
effects, including improvement in endothelial function, inhibition of neurohormonal
activation, and reduction in levels of proinflammatory cytokines. Based on the above
concepts, some patients with infrarenal abdominal aortic aneurysms received statin therapies
and then the growth rate of aneurysms slowed down.
Therefore, the investigators may hypothesize that Atorvastatin is helpful in the regression
of persistent coronary lesions in KD patients due to its effect of anti-inflammation. In
NTUH, there are about 20 KD patients with coronary lesions persistent for many years. And
the investigators plan to conduct the clinical trial with atorvastatin to evaluate the
effects of Atorvastatin on the persistent coronary arterial lesions/aneurysms in children
with Kawasaki disease including safety and efficacy.
Methods
There are around 20 KD patients eligible for this study. After they sign the IRB-approved
ICF, they will be enrolled for this study. Briefly, this study is divided into three stages:
screening & enrollment stage (I), treatment & follow-up stage (II) for 1 year and final data
analysis stage (III). Measurements include basic vital sign, electrocardiography, liver
function, muscle enzyme, inflammatory markers and echocardiography.
Predicted results
1.Oral atorvastatin therapy can effectively prevent the progression of coronary lesions in
KD patients.
;
Endpoint Classification: Safety/Efficacy Study, Intervention Model: Single Group Assignment, Masking: Open Label, Primary Purpose: Treatment
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