The Effects of Ezetimibe on Coronary Plaque Volume in Pat... | NCT01068093

Studies
The Effects of Ezetimibe on Coronary Plaque Volume in Patients With Acute Coronary Syndrome

NCT01068093

Sponsor

Yokohama City University Medical Center

Status

Unknown status

Last Update Posted

Oct 22, 2010Estimated

Enrollment

120Estimated

Phase

Phase 4

Conditions

Coronary Artery Disease

Interventions

Ezetimibe

Countries

Japan

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

Oct 2010

Overall Recruitment Status or Expanded Access Status

Unknown status

Last Known Status

Recruiting

Delayed Posting

Not provided

Why Stopped

Not provided

Expanded Access Info

Start Date

Oct 2010

Primary Completion Date

Oct 2015Estimated

Completion Date

Oct 2015Estimated

First Submitted Date

Feb 11, 2010

First Submission Date that Met QC Criteria

Feb 11, 2010

First Posted Date

Feb 12, 2010Estimated

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

Oct 21, 2010

Last Update Posted Date

Oct 22, 2010Estimated

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 assess the effects of Ezetimibe on coronary plaque volume in patients with acute coronary syndrome.

Detailed Description

Previous studies reported that administration of statins in patients with coronary artery disease resulted in significant reduction of low-density lipoprotein cholesterol(LDL-C) and regression of coronary plaque volume, and a decrease in the level of LDL-C through statin treatment positively correlates with a reduction in the volume of plaques. Administration of Ezetimibe in addition to statin has been shown to be more effective at reducing LDL-C levels compared with statin monotherapy. However, the effects of Ezetimib on coronary plaque volume remain unclear. In this study, the investigators assess the effect of Ezetimibe on coronary plaque volume and tissue composition in patients with acute coronary syndrome.

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 4

Interventional Study Design

Allocation

Biospecimen

No data available

No data is available for this block.

Enrollment

120Estimated

Name	Type	Description	Arm Group Labels	Other Names
Ezetimibe	Drug	10mg daily

Outcomes Module

Primary Outcomes

Measure	Description	Time Frame
the percent change in coronary plaque volume, the percent change in integrated backscatter signal obtained by integrated backscatter IVUS		9-11 months

Secondary Outcomes

Measure	Description	Time Frame
absolute change from baseline in coronary plaque volume, absolute and percent changes in minimal lumen diameter and percent stenosis, absolute and percent changes in total cholesterol and low-density lipoprotein cholesterol		9-11 months

Other Outcomes

Not provided

Eligibility Module

Eligibility Criteria

Inclusion Criteria:

Patients who have been diagnosed as acute coronary syndrome, and successful percutaneous coronary intervention (PCI) were performed with intravascular ultrasound (IVUS) guidance.
Patients having coronary plaques (≧ 500 µm in thickness or % plaque of 20% or more at ≧ 5 mm distal or proximal to the previously treated area in the same branch of coronary artery.

Exclusion Criteria:

Patients with bypass graft or in-stent restenosis at the site of PCI.
Patients who received PCI in the past on the lesion where the evaluation of coronary plaque volume is planned.
Patients who had plaques in a non-culprit site and might receive PCI during the treatment period.
Patients receiving lipid-lowering drugs (statins, fibrates, probucol, nicotinic acid or cholesterol absorption inhibitors).
Patients with familial hypercholesterolemia.
Patients with cardiogenic shock.
Patients receiving cyclosporine.
Patients with any allergy to Ezetimibe.
Patients with hepatobiliary disorders.
Pregnant women, women suspected of being pregnant, or lactating women.
Patients with renal disorders or undergoing dialysis.
Patients who are ineligible in the opinion of the investigator.

Accepts Healthy Volunteers

Sex

All

Sex/Gender Based

Not provided

Sex/Gender Description

Not provided

Minimum Age

20 Years

Maximum Age

Not provided

Standard Ages

AdultOlder Adult

Study Population

Not provided

Sampling Method

Not provided

Contacts/Locations Module

Central Contacts

Name	Role	Phone	Extension	Email
Kiyoshi Hibi	Contact	81-45-261-5656	7205	hibikiyo@yokohama-cu.ac.jp

Overall Officials

Name	Affiliation	Role
Kiyoshi Hibi	Yokohama City University Medical Center	Principal Investigator

Locations

Facility	Status	City	State	ZIP	Country	Contacts
Yokohama City University Medical Center	Recruiting	Yokohama	Kanagawa	231-0045	Japan

ID	Term
D003327	Coronary Disease
D017202	Myocardial Ischemia
D006331	Heart Diseases
D002318	Cardiovascular Diseases

ID	Term
D001384	Azetidines
D001385	Azetines
D006573	Heterocyclic Compounds, 1-Ring
D006571	Heterocyclic Compounds