NCT01245894已完成4 期
Effect of Intensive Lipid Lowering Treatment Compared to Moderate Lipid Lowering Treatment on the Coronary Microcirculation
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
- 87
- 试验地点
- 1
- 主要终点
- The primary endpoint was the change from baseline in Index of microcirculatory resistance(IMR).
研究概览
简要总结
The aim of this study was to measure the effect of low- and high-dose lipid-lowering treatment with rosuvastatin on the coronary physiology parameters.
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 (Investigator)
入排标准
- 年龄范围
- 18 Years 至 81 Years（Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •ST-segment elevation myocardial infarction
- •no prior treatment with statins and
- •a non significant lesion in one of the two non-culprit coronary arteries
排除标准
- •age below 18 or above 81 years,
- •unconscious patients,
- •serum creatinine > 176μmol/L,
- •hypothyroidism ((TSH > 1.5 x ULN (upper limit of normal)),
- •current liver disease (ALAT > 2 x ULN),
- •unexplained creatine kinase > 3 x ULN,
- •alcohol or drug abuse within the last five years,
- •prior myopathy or serious hypersensitivity reaction caused by statins,
- •women with childbearing potential who were not using chemical or mechanical contraception,
- •pregnant or breastfeeding women,
- •history of malignancy unless a disease-free period of more than five years was present,
- •patients with abnormal lung function test (LFT),
- •participation in another investigational drug study less than four weeks before enrolment in the present study,
- •treatment with cyclosporine or fibrates
研究组 & 干预措施
Low-dose Rosuvastatin
Active Comparator
5mg Rosuvastatin/day
干预措施: Low-dose Rosuvastatin (Drug)
High-dose Rosuvastatin
Active Comparator
Rosuvastatin 40mg/day
干预措施: High-dose Rosuvastatin (Drug)
结局指标
主要结局
The primary endpoint was the change from baseline in Index of microcirculatory resistance(IMR).
时间窗: One year
次要结局
- The secondary endpoints were the changes from baseline in Fractional Flow Reserve (FFR) and lipid values.(One year)
研究者
研究点 (1)
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