NCT00700037已完成4 期
Effect of Atorvastatin Therapy on Fibrous Cap Thickness in Coronary Atherosclerotic Plaque as Assessed by Optical Coherence Tomography
适应症
干预措施
相关药物
试验速览
- 阶段
- 4 期
- 状态
- 已完成
- 入组人数
- 70
- 试验地点
- 1
- 主要终点
- Fibrous cap thickness by OCT
研究概览
简要总结
To examine effects of intensive lipid lowering therapy with atorvastatin on stabilization of coronary plaque by using optical coherence tomography (OCT) in patients with acute coronary syndrome.
详细描述
Patients with acute coronary syndrome (myocardial infarction or unstable angina) who will undergo PCI and have at least one atherosclerotic lesion of >25% stenosis other than culprit lesions of current ACS are enrolled. Fibrous cap thickness of a target coronary plaque is evaluated by optical coherence tomography.
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
- Single (Outcomes Assessor)
入排标准
- 年龄范围
- 20 Years 至 75 Years（Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •Patients with acute coronary syndrome (myocardial infarction or unstable angina) who will undergo PCI.
- •plasma LDL cholesterol levels : >=100mg/dL and ≤160mg/dL
- •at least one atherosclerotic lesion of >25% stenosis other than culprit lesions of current ACS
排除标准
- •Patients who will undergo coronary bypass surgery.
- •Patients with major complications during treatment of culprit coronary lesions.
- •Patients with an atherosclerotic lesion with >50% stenosis at a left main trunk.
研究组 & 干预措施
1
Experimental
Atorvastatin 20mg
干预措施: high-dose atorvastatin (Drug)
2
Active Comparator
atorvastatin 5mg
干预措施: low-dose atorvastatin (Drug)
结局指标
主要结局
Fibrous cap thickness by OCT
时间窗: 12 months
次要结局
- macrophage number(12 months)
研究者
Shigeho Takarada
MD, PhD
Wakayama Medical University
研究点 (1)
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