Acute Coronary Syndrome
Conditions
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.
Interventions
DEVICEZotalolimus Eluting Stent
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.
DEVICEEverolimus eluting stent
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.
DRUGEzetimibe 10mg & Simvastatin 40mg
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)
DRUGPravastatin 20mg
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)
Sponsors
Yonsei University
Study design
Allocation
RANDOMIZED
Intervention model
PARALLEL
Primary purpose
TREATMENT
Masking
NONE
Eligibility
Sex/Gender
ALL
Age
20 Years to No maximum
Healthy volunteers
No
Inclusion criteria
General inclusion criteria 1. Acute coronary syndrome including unstable angina, acute non-ST elevation myocardial infarction and acute ST elevation myocardial infarction 2. Age of 20 years or older 3. Patients with signed informed consent Angiographic inclusion criteria 1. De novo lesion without significant plaque (angiographic lumen diameter stenosis \< 50%) 2. Reference vessel diameter ?\> 3.0 mm by operator assessment 3. Segment length of 10-20 mm 4. Distance from the PCI site \> 5.0mm (either proximal or distal) 5. Available for serial high quality IVUS studies of the entire segment.
Exclusion criteria
1. Failed PCI 2. Recommended coronary artery bypass grafting (CABG) 3. Cardiogenic Shock 4. Administration of lipid lowering agents before enrollment 5. Significant hepatic dysfunction (3 times normal reference values) 6. Significant renal dysfunction (Serum creatinine \> 2.0 mg/dl) 7. Significant leukopenia, thrombocytopenia, anemia, or known bleeding diathesis 8. Pregnant women or women with potential childbearing 9. Saphenous vein graft
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| Quantitative change in fibrofatty component of plaque measured by VH-IVUS | baseline and 3 months |
Countries
South Korea
Outcome results
None listed