NCT01857843已完成4 期
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
适应症
干预措施
试验速览
- 阶段
- 4 期
- 状态
- 已完成
- 入组人数
- 160
- 试验地点
- 1
- 主要终点
- Quantitative change in fibrofatty component of plaque measured by VH-IVUS
研究概览
简要总结
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.
研究设计
- 研究类型
- Interventional
- 分配方式
- Randomized
- 干预模型
- Parallel
- 主要目的
- Treatment
- 盲法
- None
入排标准
- 年龄范围
- 20 Years 至 —（Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •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.
排除标准
- •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
研究组 & 干预措施
ZES group
Experimental
干预措施: Zotalolimus Eluting Stent (Device)
EES group
Active Comparator
干预措施: Everolimus eluting stent (Device)
Vytorin group
Experimental
干预措施: Ezetimibe 10mg & Simvastatin 40mg (Drug)
Mevalotin group
Active Comparator
干预措施: Pravastatin 20mg (Drug)
结局指标
主要结局
Quantitative change in fibrofatty component of plaque measured by VH-IVUS
时间窗: baseline and 3 months
次要结局
未报告次要终点
研究者
研究点 (1)
Loading locations...
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