Early Effects of Intensive Lipid Lowering Treatment With Ezetimibe/ Simvastatin (Vytorin®) Assessed by Virtual Histology-Intravascular Ultrasound (VH-IVUS) and Optical Coherence Tomography (OCT) on Plaque Characteristics in Patients With Acute Coronary Syndrome

Study Overview
=================
Brief Summary
-----------------
Objective: To evaluate the early effects of intensive lipid lowering treatments with ezetimibe/simvastatin (Vytorin®) for each component of coronary plaques. Study Design Prospective, randomized, single-center study of each 80 subjects enrolled Subjects with acute coronary syndrome who meet all inclusion and exclusion criteria will be enrolled. Eligible subjects will be randomized 1:1 to A) Ezetimibe/Simvastatin (n=80) vs. B) Pravastatin (n=80), and each group of patients will be randomized further in a ratio of 1:1 to a) ZES (n=40) vs. b) EES (n=40), according to the type of stent used. All subjects will undergo VH-IVUS at initial procedure. Follow-up VH-IVUS will be performed at 3 months after index procedure. OCT at initial procedure and 3-months will be performed in available cases.

Conditions
-----------------
Acute Coronary Syndrome

Intervention / Treatment
-----------------
* Device: Zotalolimus Eluting Stent
* Device: Everolimus eluting stent
* Drug: Ezetimibe 10mg & Simvastatin 40mg
* Drug: Pravastatin 20mg


Participation Criteria
=================
Eligibility Criteria
-----------------
Inclusion Criteria: General inclusion criteria Acute coronary syndrome including unstable angina, acute non-ST elevation myocardial infarction and acute ST elevation myocardial infarction Age of 20 years or older Patients with signed informed consent Angiographic inclusion criteria De novo lesion without significant plaque (angiographic lumen diameter stenosis < 50%) Reference vessel diameter ?> 3.0 mm by operator assessment Segment length of 10-20 mm Distance from the PCI site > 5.0mm (either proximal or distal) Available for serial high quality IVUS studies of the entire segment. Exclusion Criteria: Failed PCI Recommended coronary artery bypass grafting (CABG) Cardiogenic Shock Administration of lipid lowering agents before enrollment Significant hepatic dysfunction (3 times normal reference values) Significant renal dysfunction (Serum creatinine > 2.0 mg/dl) Significant leukopenia, thrombocytopenia, anemia, or known bleeding diathesis Pregnant women or women with potential childbearing Saphenous vein graft

Ages Eligible for Study
-----------------
Minimum Age: 20 Years

Sexes Eligible for Study
-----------------
All

Accepts Healthy Volunteers
-----------------
No

Study Plan
=================
How is the study designed?
-----------------

Design Details

Primary Purpose: Treatment
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: None (Open Label)


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Experimental: ZES group<br> | Device: Zotalolimus Eluting Stent<br>* Permuted block randomization into 4 groups according to the type of drug and stent will be carried out in a ratio of 1:1:1:1(i.e.,Vytorin-ZES, Vytorin-EES, mevalotin-ZES, or mevalotin-EES) for balanced randomization. Patients with native coronary arteries who fulfill all enrollment criteria for OCT study will be randomized to receive either ZES (Endeavor®-Sprint or Resolute-integrity) or EES (Xience®) in a ratio of 1:1.<br>|
| Active Comparator: EES group<br> | Device: Everolimus eluting stent<br>* Permuted block randomization into 4 groups according to the type of drug and stent will be carried out in a ratio of 1:1:1:1(i.e.,Vytorin-ZES, Vytorin-EES, mevalotin-ZES, or mevalotin-EES) for balanced randomization. Patients with native coronary arteries who fulfill all enrollment criteria for OCT study will be randomized to receive either ZES (Endeavor®-Sprint or resolute-integrity) or EES (Xience®) in a ratio of 1:1.<br>|
| Experimental: Vytorin group<br> | Drug: Ezetimibe 10mg & Simvastatin 40mg<br>* Permuted block randomization into 4 groups according to the type of drug and stent will be carried out in a ratio of 1:1:1:1(i.e.,Vytorin-ZES, Vytorin-EES, mevalotin-ZES, or mevalotin-EES) for balanced randomization. Patients will be randomized in a ratio of 1:1 according to the two different types of lipid lowering treatment. Ezetimibe 10mg/Simvastatin 40mg (Vytorin®, MSD) Pravastatin 20mg (mevalotin®, BMS)<br>|
| Active Comparator: Mevalotin group<br> | Drug: Pravastatin 20mg<br>* Permuted block randomization into 4 groups according to the type of drug and stent will be carried out in a ratio of 1:1:1:1(i.e.,Vytorin-ZES, Vytorin-EES, mevalotin-ZES, or mevalotin-EES) for balanced randomization. Patients will be randomized in a ratio of 1:1 according to the two different types of lipid lowering treatment. Ezetimibe 10mg/Simvastatin 40mg (Vytorin®, MSD) Pravastatin 20mg (mevalotin®, BMS)<br>|

What is the study measuring?
-----------------
Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Quantitative change in fibrofatty component of plaque measured by VH-IVUS |  | baseline and 3 months |