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

Primary Purpose

Coronary Artery Disease

Status
Unknown status
Phase
Phase 4
Locations
Japan
Study Type
Interventional
Intervention
Ezetimibe
Sponsored by
Yokohama City University Medical Center
About
Eligibility
Locations
Outcomes
Full info

About this trial

This is an interventional treatment trial for Coronary Artery Disease

Eligibility Criteria

20 Years - undefined (Adult, Older Adult)All SexesDoes not accept healthy volunteers

Inclusion Criteria:

  1. Patients who have been diagnosed as acute coronary syndrome, and successful percutaneous coronary intervention (PCI) were performed with intravascular ultrasound (IVUS) guidance.
  2. 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:

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

Sites / Locations

  • Yokohama City University Medical CenterRecruiting

Outcomes

Primary Outcome Measures

the percent change in coronary plaque volume, the percent change in integrated backscatter signal obtained by integrated backscatter IVUS

Secondary Outcome Measures

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

Full Information

First Posted
February 11, 2010
Last Updated
October 21, 2010
Sponsor
Yokohama City University Medical Center
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1. Study Identification

Unique Protocol Identification Number
NCT01068093
Brief Title
The Effects of Ezetimibe on Coronary Plaque Volume in Patients With Acute Coronary Syndrome
Official Title
Assessment of the Effects of Ezetimibe on Coronary Plaque Volume in Patients With Acute Coronary Syndrome
Study Type
Interventional

2. Study Status

Record Verification Date
October 2010
Overall Recruitment Status
Unknown status
Study Start Date
October 2010 (undefined)
Primary Completion Date
October 2015 (Anticipated)
Study Completion Date
October 2015 (Anticipated)

3. Sponsor/Collaborators

Name of the Sponsor
Yokohama City University Medical Center

4. Oversight

Data Monitoring Committee
No

5. Study Description

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.

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Coronary Artery Disease

7. Study Design

Primary Purpose
Treatment
Study Phase
Phase 4
Interventional Study Model
Single Group Assignment
Masking
None (Open Label)
Allocation
Randomized
Enrollment
120 (Anticipated)

8. Arms, Groups, and Interventions

Intervention Type
Drug
Intervention Name(s)
Ezetimibe
Intervention Description
10mg daily
Primary Outcome Measure Information:
Title
the percent change in coronary plaque volume, the percent change in integrated backscatter signal obtained by integrated backscatter IVUS
Time Frame
9-11 months
Secondary Outcome Measure Information:
Title
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

10. Eligibility

Sex
All
Minimum Age & Unit of Time
20 Years
Accepts Healthy Volunteers
No
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.
Central Contact Person:
First Name & Middle Initial & Last Name or Official Title & Degree
Kiyoshi Hibi
Phone
81-45-261-5656
Ext
7205
Email
hibikiyo@yokohama-cu.ac.jp
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Kiyoshi Hibi
Organizational Affiliation
Yokohama City University Medical Center
Official's Role
Principal Investigator
Facility Information:
Facility Name
Yokohama City University Medical Center
City
Yokohama
State/Province
Kanagawa
ZIP/Postal Code
231-0045
Country
Japan
Individual Site Status
Recruiting
Facility Contact:
First Name & Middle Initial & Last Name & Degree
Kiyoshi Hibi
Phone
81-45-261-5656
Ext
7205
Email
hibikiyo@yokohama-cu.ac.jp
First Name & Middle Initial & Last Name & Degree
Kiyoshi Hibi

12. IPD Sharing Statement

Learn more about this trial

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

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