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Status unknownNCT01068093Updated Oct 22, 2010

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

A Phase 4 interventional study of Ezetimibe in Coronary Artery Disease, sponsored by Yokohama City University Medical Center. Status unknown at 1 site in Japan. Open to participants aged 20 Years and older. Per ClinicalTrials.gov, last updated 2010-10-22.

Sponsored by Yokohama City University Medical Center · Phase 4, Interventional, and Treatment

The sponsor has not verified this record recently (last verified Oct 2010), so the status shown — last known as Recruiting — may be out of date.
Phase
Phase 4
Study type
Interventional
Enrollment
120
Allocation
Randomized
Ages
20 Years and older
Sex
All
01

Study summary

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

Read the 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.

02

Conditions studied

  • Coronary Artery Disease
03

In context

Coronary Artery Disease

5,676 studies on the registry are indexed under Coronary Artery Disease; 958 are open to participants now.

This study's planned enrollment of 120 is close to the median of 123 across 3,481 interventional studies indexed under Coronary Artery Disease.

Browse Coronary Artery Disease studies →

Lead sponsor

Yokohama City University Medical Center is the lead sponsor of 17 studies on the registry; none are open to participants now.

Counted across the registry records on this site, refreshed daily.

04

Who can participate

Ages eligible
20 Years and older
Sexes eligible
All
Accepts healthy volunteers
No

Go through the criteria one by one — yes, no or not sure — and take the list to your doctor or the study team. Kept in this browser only.

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

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.
05

Study design

Phase
Phase 4
Primary purpose
Treatment
Allocation
Randomized
Intervention model
Single group
Masking
None (open label)
Enrollment
120 participants (estimated)

Interventions

06

What researchers measure

Primary outcomes

  1. 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 outcomes

  1. 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

07

Study locations

1 of 1 sites recruiting
  • Yokohama City University Medical Center
    Yokohama, Kanagawa 231-0045, Japan
    Recruiting
08

Updates

Tracking since Sep 25, 2026
No changes since tracking began. The registry record was last updated on Oct 22, 2010, before this site started recording changes on Sep 25, 2026. Its history is on ClinicalTrials.gov ↗
09

Registry details

Key details

Study ID
NCT01068093
Lead sponsor
Yokohama City University Medical Center
First posted
Feb 12, 2010
Start date
Oct 2010
Primary completion
Oct 2015 (estimated)
Completion
Oct 2015 (estimated)
Last update
Oct 22, 2010

Study contacts

Kiyoshi Hibi
Contact
hibikiyo@yokohama-cu.ac.jp
81-45-261-5656 ext. 7205
Kiyoshi Hibi
principal investigator · Yokohama City University Medical Center

Oversight

Data monitoring committee
No
View the source record on ClinicalTrials.gov ↗

Not currently enrolling

This study is status unknown, as verified in Oct 2010. You cannot join it, but the record below documents what was studied.

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