Trial of Atorvastatin on the Persistent Coronary Aneurysm in Children With Kawasaki Disease

NCT02114099 | Unknown Phase 2

• 1 other identifier: 200612128M
• Study Type: interventional
• Target: 20
• Locations: 1 country
• Sites: 1

Brief Summary

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.

Conditions

Kawasaki Disease; Aneurysm, Coronary

Keywords

Kawasaki Disease; Aneurysm, Coronary

Outcome Measures

Primary Outcomes (1)

• size of coronary aneurysm

  2 years

Secondary Outcomes (1)

• muscle enzyme and liver function

  2 years

Study Arms (1)

Atorvastatin

EXPERIMENTAL

prescribe Atorvastatin to see its effect

Drug: Atorvastatin

Interventions

Atorvastatin DRUG

10 mg qd x1 year

Also known as: Lipitor

Atorvastatin

Eligibility Criteria

• Age: 10 Years+
• Sex: all
• Healthy Volunteers: No
• Age Groups: Child (0-17), Adult (18-64), Older Adult (65+)

You may qualify if:

• Clinical diagnosis of Kawasaki Disease with giant aneurysm
• Must be older than 10 years old

You may not qualify if:

• 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.

Sponsors & Collaborators

• National Taiwan University Hospital: lead
• National Science and Technology Council, Taiwan: collaborator

Study Sites (1)

National Taiwan University Hospital

Taipei, 100, Taiwan

RECRUITING

MeSH Terms

Conditions

Mucocutaneous Lymph Node Syndrome; Coronary Aneurysm

Interventions

Atorvastatin

Condition Hierarchy (Ancestors)

Vasculitis; Vascular Diseases; Cardiovascular Diseases; Lymphatic Diseases; Hemic and Lymphatic Diseases; Skin Diseases, Vascular; Skin Diseases; Skin and Connective Tissue Diseases; Coronary Disease; Myocardial Ischemia; Heart Diseases; Aneurysm

Intervention Hierarchy (Ancestors)

Pyrroles; Azoles; Heterocyclic Compounds, 1-Ring; Heterocyclic Compounds; Heptanoic Acids; Fatty Acids; Lipids

Study Officials

• Ming-Tai Lin, MD

  National Taiwan University Hospital

  PRINCIPAL INVESTIGATOR

Central Study Contacts

Ming-Tai Lin, MD

CONTACT

886-2-23123456; mingtailin@ntu.edu.tw

Study Design

• Study Type: interventional
• Phase: phase 2
• Allocation: NA
• Masking: NONE
• Purpose: TREATMENT
• Intervention Model: SINGLE GROUP
• Sponsor Type: OTHER
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: June 28, 2010
• First Posted: April 15, 2014
• Study Start: June 1, 2007
• Primary Completion: December 1, 2015
• Study Completion: December 1, 2016
• Last Updated: April 15, 2014

Record last verified: 2014-04

Locations

TW (1)