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

Yokohama City University Medical Center

Status and phase: Unknown; Phase 4

Conditions: Coronary Artery Disease

Treatments: Drug: Ezetimibe

Study type: Interventional

Funder types: Other

Identifiers

NCT01068093

Y-ACS-E

Details and patient eligibility

About

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

Full 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.

Enrollment: 120 estimated patients

Sex: All

Ages: 20+ years old

Volunteers: No Healthy Volunteers

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.

Trial design

Primary purpose: Treatment

Allocation: Randomized

Interventional model: Single Group Assignment

Masking: None (Open label)