A Phase 2 interventional study of Atorvastatin in Kawasaki Disease and Aneurysm, Coronary, sponsored by National Taiwan University Hospital. Status unknown at 1 site in Taiwan. Open to participants aged 10 Years and older. Per ClinicalTrials.gov, last updated 2014-04-15.
Sponsored by National Taiwan University Hospital · Phase 2, Interventional, and Treatment
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.
960 studies on the registry are indexed under Aneurysm; 175 are open to participants now.
This study's planned enrollment of 20 is below the median of 72 across 462 interventional studies indexed under Aneurysm.
Browse Aneurysm studies →National Taiwan University Hospital is the lead sponsor of 2,563 studies on the registry; 569 are open to participants now.
Of its 11 completed or terminated interventional studies of FDA-regulated products, 2 (18%) have results posted.
Counted across the registry records on this site, refreshed daily.
Exclusion Criteria:
prescribe Atorvastatin to see its effect
Drug: Atorvastatin
10 mg qd x1 year
Also known as: Lipitor
size of coronary aneurysm
Time frame: 2 years
muscle enzyme and liver function
Time frame: 2 years
This study is status unknown, as verified in Apr 2014. You cannot join it, but the record below documents what was studied.
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National Taiwan University Hospital