Cardiovascular Risk Markers and Response to Statins After... | NCT00305201

Studies
Cardiovascular Risk Markers and Response to Statins After Kawasaki Disease

NCT00305201

Sponsor

Pontificia Universidad Catolica de Chile

Status

Withdrawn

Last Update Posted

May 24, 2016Estimated

Enrollment

0Actual

Phase

Phase 2

Conditions

Kawasaki Disease

Interventions

pravastatin

Countries

Chile

Protocol Section

Identification Module Status Module Sponsor/Collaborators Module Oversight Module Description Module Conditions Module Design Module Arms/Interventions Module Outcomes Module Eligibility Module Contacts/Locations Module References Module IPD Sharing Statement Module

Results Section

Participant Flow Module Baseline Characteristics Module Outcome Measures Module Adverse Events Module More Info Module

Annotation Section

Annotation Module

Document Section

Large Document Module

Derived Section

Miscellaneous Info Module Condition Browse Module Intervention Browse Module

Protocol Section

Identification Module

NCT ID

Results Section

No data available

No data is available for this block.

Annotation Section

No data available

No data is available for this block.

Document Section

No data available

No data is available for this block.

Derived Section

Miscellaneous Info Module

Version Holder

Status Module

Record Verification Date

May 2016

Overall Recruitment Status or Expanded Access Status

Withdrawn

Last Known Status

Not provided

Delayed Posting

Not provided

Why Stopped

Withdrawn due to lack of study participants

Expanded Access Info

Start Date

Apr 2006

Primary Completion Date

Not provided

Completion Date

May 2007Estimated

First Submitted Date

Mar 20, 2006

First Submission Date that Met QC Criteria

Mar 20, 2006

First Posted Date

Mar 21, 2006Estimated

Results Waived

Not provided

Results First Submitted Date

Not provided

Results First Submitted that Met QC Criteria

Not provided

Results First Posted Date

Not provided

Certification/Extension (aka Delayed Results) First Submitted Date

Not provided

Certification/Extension First Submitted that Passed QC Review

Not provided

Certification/Extension First Posted Date

Not provided

Last Update Submitted Date

May 22, 2016

Last Update Posted Date

May 24, 2016Estimated

Sponsor/Collaborators Module

Responsible Party, by Official Title

Not provided

Lead Sponsor

Pontificia Universidad Catolica de ChileOTHER

Collaborators

Name	Class
Bristol-Myers Squibb	INDUSTRY

Oversight Module

Has Data Monitoring Committee (DMC)

Is FDA Regulated Drug

Not provided

Is FDA Regulated Device

Not provided

Is Unapproved Device

Not provided

Pediatric Postmarket Surveillance of a Device Product

Not provided

Product Exported from US

Not provided

FDAAA801 Violation

Not provided

Description Module

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.

Design Module

Study Type

Interventional

Number of References to an Expanded Access Study

Not provided

Expanded Access Types

Not provided

Patient Registry

Not provided

Target Follow-Up Duration

Not provided

Phases

Phase 2

Interventional Study Design

Allocation

Biospecimen

No data available

No data is available for this block.

Enrollment

0Actual

Name	Type	Description	Arm Group Labels	Other Names
pravastatin	Drug

Outcomes Module

Primary Outcomes

Measure	Description	Time Frame
Percent of change in brachial artery dilatation after statin therapy

Secondary Outcomes

Measure	Description	Time Frame
Decrease in LDL
Increase in HDL
Decrease in triglycerides

Other Outcomes

Not provided

Eligibility Module

Eligibility Criteria

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)

Accepts Healthy Volunteers

Sex

All

Sex/Gender Based

Not provided

Sex/Gender Description

Not provided

Minimum Age

8 Years

Maximum Age

25 Years

Standard Ages

ChildAdult

Study Population

Not provided

Sampling Method

Not provided

Contacts/Locations Module

Central Contacts

Not provided

Overall Officials

Name	Affiliation	Role
Arturo Borzutzky, MD	Pontificia Universidad Catolica de Chile, School of Medicine, Department of Pediatrics	Principal Investigator
Miguel Gutierrez, MD	Pontificia Universidad Catolica de Chile, School of Medicine, Department of Rheumatology and Clinical Immunology	Study Director

Locations

Facility	Status	City	State	ZIP	Country	Contacts
Pontificia Universidad Catolica de Chile, School of Medicine		Santiago	Santiago Metropolitan		Chile

References Module

Citations

PubMed Identifier	Type	Citation	Retractions
8822996	Background	Kato H, Sugimura T, Akagi T, Sato N, Hashino K, Maeno Y, Kazue T, Eto G, Yamakawa R. Long-term consequences of Kawasaki disease. A 10- to 21-year follow-up study of 594 patients. Circulation. 1996 Sep 15;94(6):1379-85. doi: 10.1161/01.cir.94.6.1379.
8901658	Background	Dhillon R, Clarkson P, Donald AE, Powe AJ, Nash M, Novelli V, Dillon MJ, Deanfield JE. Endothelial dysfunction late after Kawasaki disease. Circulation. 1996 Nov 1;94(9):2103-6. doi: 10.1161/01.cir.94.9.2103.

ID	Term
D014657	Vasculitis
D014652	Vascular Diseases
D002318	Cardiovascular Diseases
D008206	Lymphatic Diseases

ID	Term
D009281	Naphthalenes
D011084	Polycyclic Aromatic Hydrocarbons
D006841	Hydrocarbons, Aromatic
D006844	Hydrocarbons, Cyclic