Trial of Atorvastatin on the Persistent Coronary Aneurysm in Children With Kawasaki Disease
Keywords
Abstract
Description
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.
Dates
| Last Verified: | 03/31/2014 |
| First Submitted: | 06/27/2010 |
| Estimated Enrollment Submitted: | 04/13/2014 |
| First Posted: | 04/14/2014 |
| Last Update Submitted: | 04/13/2014 |
| Last Update Posted: | 04/14/2014 |
| Actual Study Start Date: | 05/31/2007 |
| Estimated Primary Completion Date: | 11/30/2015 |
| Estimated Study Completion Date: | 11/30/2016 |
Condition or disease
Intervention/treatment
Drug: Atorvastatin
Phase
Arm Groups
| Arm | Intervention/treatment |
|---|---|
| Experimental: Atorvastatin prescribe Atorvastatin to see its effect | Drug: Atorvastatin 10 mg qd x1 year |
Eligibility Criteria
| Ages Eligible for Study | 10 Years To 10 Years |
| Sexes Eligible for Study | All |
| Accepts Healthy Volunteers | Yes |
| Criteria | Inclusion Criteria: - Clinical diagnosis of Kawasaki Disease with giant aneurysm - Must be older than 10 years old Exclusion Criteria: - Subjects ever received coronary artery bypass graft (CABG) surgery. - Subjects have active hepatitis or persistent abnormal liver function such as elevated GOT and GPT. - Subjects have the past history of rhabdomyolysis. - Female subjects are pregnant or plan for child-bearing during study periods. |
Outcome
Primary Outcome Measures
1. size of coronary aneurysm [2 years]
Secondary Outcome Measures
1. muscle enzyme and liver function [2 years]
