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.
Study Type
INTERVENTIONAL
Allocation
RANDOMIZED
Purpose
TREATMENT
Masking
NONE
Enrollment
160
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.
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.
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. 1. Ezetimibe 10mg/Simvastatin 40mg (Vytorin®, MSD) 2. Pravastatin 20mg (mevalotin®, BMS)
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. 1. Ezetimibe 10mg/Simvastatin 40mg (Vytorin®, MSD) 2. Pravastatin 20mg (mevalotin®, BMS)
Severance Hospital
Seoul, Seoul, South Korea
Quantitative change in fibrofatty component of plaque measured by VH-IVUS
Time frame: baseline and 3 months
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