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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
  Purpose

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
Endpoint Classification: Efficacy Study
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:

Drug Information available for: Ezetimibe
U.S. FDA Resources

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 ] [ Designated as safety issue: No ]

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 ] [ Designated as safety issue: No ]

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.

  Eligibility

Ages Eligible for Study:   20 Years and older
Genders Eligible for Study:   Both
Accepts Healthy Volunteers:   No
Criteria

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
Please refer to this study by its ClinicalTrials.gov identifier: NCT01068093

Contacts
Contact: Kiyoshi Hibi 81-45-261-5656 ext 7205 hibikiyo@yokohama-cu.ac.jp

Locations
Japan
Yokohama City University Medical Center Recruiting
Yokohama, Kanagawa, Japan, 231-0045
Contact: Kiyoshi Hibi     81-45-261-5656 ext 7205     hibikiyo@yokohama-cu.ac.jp    
Principal Investigator: Kiyoshi Hibi            
Sponsors and Collaborators
Yokohama City University Medical Center
Investigators
Principal Investigator: Kiyoshi Hibi Yokohama City University Medical Center
  More Information

No publications provided

Responsible Party: Kiyoshi Hibi, Yokohama City University Medical Center
ClinicalTrials.gov Identifier: NCT01068093     History of Changes
Other Study ID Numbers: Y-ACS-E
Study First Received: February 11, 2010
Last Updated: October 21, 2010
Health Authority: Japan: Institutional Review Board

Additional relevant MeSH terms:
Coronary Artery Disease
Myocardial Ischemia
Coronary Disease
Acute Coronary Syndrome
Heart Diseases
Cardiovascular Diseases
Arteriosclerosis
Arterial Occlusive Diseases
Vascular Diseases
Angina Pectoris
Chest Pain
 Pain
Signs and Symptoms
Ezetimibe
Anticholesteremic Agents
Hypolipidemic Agents
Antimetabolites
Molecular Mechanisms of Pharmacological Action
Pharmacologic Actions
Lipid Regulating Agents
Therapeutic Uses

ClinicalTrials.gov processed this record on May 23, 2013