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

This study is currently recruiting participants.

Verified October 2010 by Yokohama City University Medical Center

Sponsor:

Information provided by:

Yokohama City University Medical Center

ClinicalTrials.gov Identifier:

NCT01068093

First received: February 11, 2010

Last updated: October 21, 2010

Last verified: October 2010

History of Changes

Tracking Information

First Received Date ^ICMJE

February 11, 2010

Last Updated Date

October 21, 2010

Start Date ^ICMJE

October 2010

Estimated Primary Completion Date

October 2015 (final data collection date for primary outcome measure)

Current Primary Outcome Measures ^ICMJE

the percent change in coronary plaque volume, the percent change in integrated backscatter signal obtained by integrated backscatter IVUS [ Time Frame: 9-11 months ] [ Designated as safety issue: No ]

Original Primary Outcome Measures ^ICMJE

Same as current

Change History

Complete list of historical versions of study NCT01068093 on ClinicalTrials.gov Archive Site

Current Secondary Outcome Measures ^ICMJE

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 ] [ Designated as safety issue: No ]

Original Secondary Outcome Measures ^ICMJE

Same as current

Current Other Outcome Measures ^ICMJE

Not Provided

Original Other Outcome Measures ^ICMJE

Not Provided

Descriptive Information

Brief Title ^ICMJE

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

Official Title ^ICMJE

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

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.

Study Type ^ICMJE

Interventional

Study Phase

Phase 4

Study Design ^ICMJE

Allocation: Randomized
Endpoint Classification: Efficacy Study
Intervention Model: Single Group Assignment
Masking: Open Label
Primary Purpose: Treatment

Condition ^ICMJE

Coronary Artery Disease

Intervention ^ICMJE

Drug: Ezetimibe

10mg daily

Study Arm (s)

Not Provided

Publications *

Not Provided

* 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

Recruiting

Estimated Enrollment ^ICMJE

120

Estimated Completion Date

October 2015

Estimated Primary Completion Date

October 2015 (final data collection date for primary outcome measure)

Eligibility Criteria ^ICMJE

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.

Gender

Both

Ages

20 Years and older

Accepts Healthy Volunteers

Contacts ^ICMJE

Contact: Kiyoshi Hibi

81-45-261-5656 ext 7205

hibikiyo@yokohama-cu.ac.jp

Location Countries ^ICMJE

Japan

Administrative Information

NCT Number ^ICMJE

NCT01068093

Other Study ID Numbers ^ICMJE

Y-ACS-E

Has Data Monitoring Committee

Responsible Party

Kiyoshi Hibi, Yokohama City University Medical Center

Study Sponsor ^ICMJE

Yokohama City University Medical Center

Collaborators ^ICMJE

Not Provided

Investigators ^ICMJE

Principal Investigator:

Kiyoshi Hibi

Yokohama City University Medical Center

Information Provided By

Yokohama City University Medical Center

Verification Date

October 2010

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

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