NCT00760786Unknown不适用
Effects of Intensive Lipid Lowering and Omega-3 Fatty Acid on Composition of Coronary Atherosclerotic Plaque: Serial Virtual Histology Intravascular Ultrasound Analysis
适应症
干预措施
相关药物
试验速览
- 阶段
- 不适用
- 入组人数
- 60
- 试验地点
- 1
- 主要终点
- Plaque stabilization using serial virtual histology intravascular ultrasound analysis
研究概览
简要总结
The purpose of this study is to determine whether intensive lipid lowering and Omega-3 fatty acid are effective in the treatment of coronary atherosclerotic plaque.
研究设计
- 研究类型
- Interventional
- 分配方式
- Randomized
- 干预模型
- Factorial
- 主要目的
- Treatment
- 盲法
- None
入排标准
- 年龄范围
- 18 Years 至 80 Years（Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •Acute coronary syndrome within 48 hours of symptom onset
- •Have de novo non-culprit coronary artery stenosis 20% to 70% by visual estimation
排除标准
- •Cardiogenic shock
- •ST segment elevation myocardial infarction within 1 week
- •Hematologic disorder: neutropenia (neutrophil<3000/mm3), thrombocytopenia (platelet<100,000/mm3)
- •Liver enzyme elevation: serum aspartate aminotransferase or alanine aminotransferase concentrations more than 3 times the upper limit of normal
- •Impaired renal function with serum creatinine > 2mg/dL
- •Bleeding diathesis or history of coagulopathy
- •Pregnancy
- •Hypersensitivity to heparin, dye, aspirin, clopidogrel, statin, or fish
研究组 & 干预措施
1
Active Comparator
Intensive lipid lowering plus Omega3-fatty acid
干预措施: Intensive lipid lowering plus Omega3-fatty acid (Drug)
2
Active Comparator
Moderate lipid lowering plus Omega3-fatty acid
干预措施: Moderate lipid lowering plus Omega3-fatty acid (Drug)
3
Active Comparator
Intensive lipid lowering plus placebo
干预措施: Intensive lipid lowering plus placebo (Drug)
4
Active Comparator
Moderate lipid lowering plus placebo
干预措施: Moderate lipid lowering plus placebo (Drug)
结局指标
主要结局
Plaque stabilization using serial virtual histology intravascular ultrasound analysis
时间窗: 1 year
次要结局
未报告次要终点
研究者
研究点 (1)
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