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

The recruitment status of this study is unknown. The completion date has passed and the status has not been verified in more than two years.
Verified October 2010 by Yokohama City University Medical Center.
Recruitment status was:  Recruiting
Information provided by:
Yokohama City University Medical Center Identifier:
First received: February 11, 2010
Last updated: October 21, 2010
Last verified: October 2010
The purpose of this study is to assess the effects of Ezetimibe on coronary plaque volume in patients with acute coronary syndrome.

Condition Intervention Phase
Coronary Artery Disease
Drug: Ezetimibe
Phase 4

Study Type: Interventional
Study Design: Allocation: Randomized
Intervention Model: Single Group Assignment
Masking: Open Label
Primary Purpose: Treatment
Official Title: Assessment of the Effects of Ezetimibe on Coronary Plaque Volume in Patients With Acute Coronary Syndrome

Resource links provided by NLM:

Further study details as provided by Yokohama City University Medical Center:

Primary Outcome Measures:
  • 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 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 [ Time Frame: 9-11 months ]

Estimated Enrollment: 120
Study Start Date: October 2010
Estimated Study Completion Date: October 2015
Estimated Primary Completion Date: October 2015 (Final data collection date for primary outcome measure)
Intervention Details:
    Drug: Ezetimibe
    10mg daily
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.

Ages Eligible for Study:   20 Years and older   (Adult, Senior)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No

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.
  Contacts and Locations
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Please refer to this study by its identifier: NCT01068093

Contact: Kiyoshi Hibi 81-45-261-5656 ext 7205

Yokohama City University Medical Center Recruiting
Yokohama, Kanagawa, Japan, 231-0045
Contact: Kiyoshi Hibi    81-45-261-5656 ext 7205   
Principal Investigator: Kiyoshi Hibi         
Sponsors and Collaborators
Yokohama City University Medical Center
Principal Investigator: Kiyoshi Hibi Yokohama City University Medical Center
  More Information

Responsible Party: Kiyoshi Hibi, Yokohama City University Medical Center Identifier: NCT01068093     History of Changes
Other Study ID Numbers: Y-ACS-E
Study First Received: February 11, 2010
Last Updated: October 21, 2010

Additional relevant MeSH terms:
Coronary Artery Disease
Myocardial Ischemia
Coronary Disease
Acute Coronary Syndrome
Heart Diseases
Cardiovascular Diseases
Arterial Occlusive Diseases
Vascular Diseases
Anticholesteremic Agents
Hypolipidemic Agents
Molecular Mechanisms of Pharmacological Action
Lipid Regulating Agents processed this record on May 25, 2017