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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Recruitment Status : Withdrawn (Withdrawn due to lack of study participants)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
Sponsor:
Collaborator:
Bristol-Myers Squibb
Information provided by:
Pontificia Universidad Catolica de Chile

Tracking Information
First Submitted Date  ICMJE March 20, 2006
First Posted Date  ICMJE March 21, 2006
Last Update Posted Date May 24, 2016
Study Start Date  ICMJE April 2006
Primary Completion Date Not Provided
Current Primary Outcome Measures  ICMJE
 (submitted: March 20, 2006)
Percent of change in brachial artery dilatation after statin therapy
Original Primary Outcome Measures  ICMJE Same as current
Change History Complete list of historical versions of study NCT00305201 on ClinicalTrials.gov Archive Site
Current Secondary Outcome Measures  ICMJE
 (submitted: March 20, 2006)
  • Decrease in LDL
  • Increase in HDL
  • Decrease in triglycerides
  • Decrease in high sensitivity CRP
Original Secondary Outcome Measures  ICMJE Same as current
Current Other Pre-specified Outcome Measures Not Provided
Original Other Pre-specified Outcome Measures Not Provided
 
Descriptive Information
Brief Title  ICMJE Cardiovascular Risk Markers and Response to Statins After Kawasaki Disease
Official Title  ICMJE Cardiovascular Risk Markers Before and After Therapy With Statins in Patients With History of Kawasaki Disease
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.
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 Type  ICMJE Interventional
Study Phase  ICMJE Phase 2
Study Design  ICMJE Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Double
Primary Purpose: Treatment
Condition  ICMJE Kawasaki Disease
Intervention  ICMJE Drug: pravastatin
Study Arms  ICMJE Not Provided
Publications *

*   Includes publications given by the data provider as well as publications identified by ClinicalTrials.gov Identifier (NCT Number) in Medline.
 
Recruitment Information
Recruitment Status  ICMJE Withdrawn
Actual Enrollment  ICMJE
 (submitted: May 22, 2016)
0
Original Enrollment  ICMJE
 (submitted: March 20, 2006)
22
Estimated Study Completion Date  ICMJE May 2007
Primary Completion Date Not Provided
Eligibility Criteria  ICMJE

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)
Sex/Gender  ICMJE
Sexes Eligible for Study: All
Ages  ICMJE 8 Years to 25 Years   (Child, Adult)
Accepts Healthy Volunteers  ICMJE No
Contacts  ICMJE Contact information is only displayed when the study is recruiting subjects
Listed Location Countries  ICMJE Chile
Removed Location Countries  
 
Administrative Information
NCT Number  ICMJE NCT00305201
Other Study ID Numbers  ICMJE PG-29/05
Has Data Monitoring Committee No
U.S. FDA-regulated Product Not Provided
IPD Sharing Statement  ICMJE Not Provided
Responsible Party Arturo Borzutzky, MD, Pontificia Universidad Catolica de Chile
Study Sponsor  ICMJE Pontificia Universidad Catolica de Chile
Collaborators  ICMJE Bristol-Myers Squibb
Investigators  ICMJE
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
PRS Account Pontificia Universidad Catolica de Chile
Verification Date May 2016

ICMJE     Data element required by the International Committee of Medical Journal Editors and the World Health Organization ICTRP