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

Yonsei University

Status and phase: Completed; Phase 4

Conditions: Acute Coronary Syndrome

Treatments: Device: Zotalolimus Eluting Stent; Drug: Ezetimibe 10mg & Simvastatin 40mg; Drug: Pravastatin 20mg; Device: Everolimus eluting stent

Study type: Interventional

Funder types: Other

Identifiers

NCT01857843

1-2009-0032

Details and patient eligibility

About

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.

Enrollment: 160 patients

Sex: All

Ages: 20+ years old

Volunteers: No Healthy Volunteers

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

Trial design

Primary purpose: Treatment

Allocation: Randomized

Interventional model: Parallel Assignment

Masking: None (Open label)

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160 participants in 4 patient groups

ZES group

Experimental group

Treatment:

Device: Zotalolimus Eluting Stent

EES group

Active Comparator group

Treatment:

Device: Everolimus eluting stent

Vytorin group

Experimental group

Treatment:

Drug: Ezetimibe 10mg & Simvastatin 40mg

Mevalotin group

Active Comparator group

Treatment:

Drug: Pravastatin 20mg