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

October 21, 2010 updated by: Yokohama City University Medical Center

Assessment of the Effects of Ezetimibe on Coronary Plaque Volume in Patients With Acute Coronary Syndrome

The purpose of this study is to assess the effects of Ezetimibe on coronary plaque volume in patients with acute coronary syndrome.

Study Overview

Status

Unknown

Conditions

Coronary Artery Disease

Intervention / Treatment

Drug: Ezetimibe

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.

Study Type

Interventional

Enrollment (Anticipated)

120

Phase

Phase 4

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Locations

Japan
- Kanagawa
  - Yokohama, Kanagawa, Japan, 231-0045
    - Recruiting
    - Yokohama City University Medical Center
    - Contact:
      
      Kiyoshi Hibi
      
      Phone Number: 7205 81-45-261-5656
      
      Email: hibikiyo@yokohama-cu.ac.jp

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

20 years and older (Adult, Older Adult)

Accepts Healthy Volunteers

Genders Eligible for Study

All

Description

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.

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

Primary Purpose: Treatment
Allocation: Randomized
Interventional Model: Single Group Assignment
Masking: None (Open Label)

What is the study measuring?

Primary Outcome Measures

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

Secondary Outcome Measures

Outcome Measure	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 Time Frame: 9-11 months	9-11 months

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

Yokohama City University Medical Center

Investigators

Principal Investigator: Kiyoshi Hibi, Yokohama City University Medical Center

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start

October 1, 2010

Primary Completion (Anticipated)

October 1, 2015

Study Completion (Anticipated)