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

Coronary Artery Disease Clinical Trial

Official title:

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

Clinical Trial Details — Status: Recruiting

Administrative data

• NCT number: NCT01068093
• Other study ID #: Y-ACS-E
• Status: Recruiting
• Phase: Phase 4
• First received: February 11, 2010
• Last updated: October 21, 2010
• Start date: October 2010
• Est. completion date: October 2015

Study information

• Verified date: October 2010
• Source: Yokohama City University Medical Center
• Contact: Kiyoshi Hibi
• Phone: 81-45-261-5656
• Email: hibikiyo[@]yokohama-cu.ac.jp
• Is FDA regulated: No
• Health authority: Japan: Institutional Review Board
• Study type: Interventional

Clinical Trial Summary

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

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.

Recruitment information / eligibility

• Status: Recruiting
• Enrollment: 120
• Est. completion date: October 2015
• Est. primary completion date: October 2015
• Accepts healthy volunteers: No
• Gender: Both
• Age group: 20 Years and older

Eligibility

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.

Study Design

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

Related Conditions & MeSH terms

• Acute Coronary Syndrome
• Coronary Artery Disease
• Coronary Disease
• Myocardial Ischemia

Intervention

Drug:
• Ezetimibe
10mg daily

Locations

Country	Name	City	State
Japan	Yokohama City University Medical Center	Yokohama	Kanagawa

Sponsors (1)

Lead Sponsor	Collaborator
Yokohama City University Medical Center

Country where clinical trial is conducted

Japan, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	the percent change in coronary plaque volume, the percent change in integrated backscatter signal obtained by integrated backscatter IVUS		9-11 months	No
Secondary	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		9-11 months	No