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Cardiovascular Risk Markers and Response to Statins After Kawasaki Disease

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ClinicalTrials.gov Identifier: NCT00305201
Recruitment Status : Withdrawn (Withdrawn due to lack of study participants)
First Posted : March 21, 2006
Last Update Posted : May 24, 2016
Information provided by:

Study Description
Brief Summary:
The purpose of this study is to determine whether Chilean children with history of Kawasaki disease have endothelial dysfunction years after the acute phase of the disease, and if this condition can be modified by treatment with statins.

Condition or disease Intervention/treatment Phase
Kawasaki Disease Drug: pravastatin Phase 2

Detailed Description:

Kawasaki disease (KD) in its acute phase produces endothelial inflammation that can lead to dilatation and aneurysms of coronary and peripheral arteries. This initial injury leads to persistent endothelial dysfunction several years after having the disease. As a consequence, these patients may have a higher cardiovascular risk than general population. Studies with HMG-CoA reductase inhibitors (statins) have suggested that these have an anti-inflammatory effect over the endothelium, that may be independent of its lipid-lowering effects. The hypothesis of this study is that KD produces endothelial dysfunction that is persistent years after acute disease, and that this dysfunction can be modified by treatment with statins.The study consists of two phases. On the first we will perform ultrasound assessment of endothelial-dependent flow-mediated vasodilation of the brachial artery and evaluate other cardiovascular risk markers in patients and healthy controls. On the second phase patients with history of Kawasaki disease will be randomized and allocated to treatment with Pravastatin or placebo, after which a new evaluation of flow-mediated dilation of the brachial artery and cardiovascular risk markers will be performed.

Comparison(s): Children older than 8 years of age with history of Kawasaki disease more than 12 months before enrollment, compared with paired by age children without history of KD or other cardiovascular risk factors.

Study Design

Study Type : Interventional  (Clinical Trial)
Actual Enrollment : 0 participants
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Double
Primary Purpose: Treatment
Official Title: Cardiovascular Risk Markers Before and After Therapy With Statins in Patients With History of Kawasaki Disease
Study Start Date : April 2006
Estimated Study Completion Date : May 2007

Arms and Interventions

Outcome Measures

Primary Outcome Measures :
  1. Percent of change in brachial artery dilatation after statin therapy

Secondary Outcome Measures :
  1. Decrease in LDL
  2. Increase in HDL
  3. Decrease in triglycerides
  4. Decrease in high sensitivity CRP

Eligibility Criteria

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Ages Eligible for Study:   8 Years to 25 Years   (Child, Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No

Inclusion Criteria:

  • History of Kawasaki disease more than 12 months before enrollment
  • Present age of 8 years or older

Exclusion Criteria:

  • Diabetes mellitus
  • Not controlled hypertension
  • Treatment with drugs thay modify endothelial function such as angiotensin converting enzyme inhibitors, angiotensin II receptor antagonists, and calcium channel blockers
  • Smokers of more than 5 cigarettes per day
  • Total cholesterol higher than 250 mg/dl
  • Triglycerides higher than 300mg/dl
  • Chronic treatment with statins
  • Chronic renal insufficiency (creatinine > 1.5 mg/dl)
Contacts and Locations

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT00305201

Pontificia Universidad Catolica de Chile, School of Medicine
Santiago, Región Metropolitana, Chile
Sponsors and Collaborators
Pontificia Universidad Catolica de Chile
Bristol-Myers Squibb
Principal Investigator: Arturo Borzutzky, MD Pontificia Universidad Catolica de Chile, School of Medicine, Department of Pediatrics
Study Director: Miguel Gutierrez, MD Pontificia Universidad Catolica de Chile, School of Medicine, Department of Rheumatology and Clinical Immunology
More Information

Responsible Party: Arturo Borzutzky, MD, Pontificia Universidad Catolica de Chile
ClinicalTrials.gov Identifier: NCT00305201     History of Changes
Other Study ID Numbers: PG-29/05
First Posted: March 21, 2006    Key Record Dates
Last Update Posted: May 24, 2016
Last Verified: May 2016

Keywords provided by Pontificia Universidad Catolica de Chile:
Mucocutaneous Lymph Node Syndrome
Kawasaki disease
Endothelial dysfunction
Statin therapy

Additional relevant MeSH terms:
Mucocutaneous Lymph Node Syndrome
Vascular Diseases
Cardiovascular Diseases
Lymphatic Diseases
Skin Diseases, Vascular
Skin Diseases
Hydroxymethylglutaryl-CoA Reductase Inhibitors
Anticholesteremic Agents
Hypolipidemic Agents
Molecular Mechanisms of Pharmacological Action
Enzyme Inhibitors
Lipid Regulating Agents