NCT00783042已完成早期 1 期
A Randomised, Double-Blind, Placebo-Controlled Study to Evaluate the Transthoracic Doppler Echocardiography Method as a Non-Invasive Method for Coronary Function Measurements; Ability to Detect Short-Term Statin Effects in Patients With Increased Cardiovascular Risk
适应症
干预措施
相关药物
试验速览
- 阶段
- 早期 1 期
- 状态
- 已完成
- 发起方
- AstraZeneca
- 入组人数
- 80
- 试验地点
- 1
- 主要终点
- Change in CFR peak velocity within rosuvastatin group after 1 month of treatment compared to baseline
研究概览
简要总结
The aim of this study is to investigate whether the non-invasive ultrasound method for assessment of coronary blood flow, transthoracic Doppler echocardiography-coronary flow reserve (TTDE-CFR), can be used to measure drug effects.
研究设计
- 研究类型
- Interventional
- 分配方式
- Randomized
- 干预模型
- Parallel
- 主要目的
- Basic Science
- 盲法
- Quadruple (Participant, Care Provider, Investigator, Outcomes Assessor)
入排标准
- 年龄范围
- 45 Years 至 75 Years（Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •Males aged 45-75 years or females aged 60-75 years inclusive
- •Carotid and/or femoral atherosclerotic plaque, as assessed by carotid ultrasound examination within the last 5 years
- •Abnormal concentrations of lipids or lipoproteins in the blood
- •Provision of signed informed consent
排除标准
- •Treatment with statins or other lipid-lowering drugs, e.g. fibrates, nicotinic acid, cholesterol absorption inhibitor, within the last 6 months before randomisation
- •Current smoking or snuff tobacco use
- •Major CV event (myocardial infarction (MI), stroke/ transitory ischemic attack (TIA), Acute Coronary Syndrome (ACS), revascularisation) within the last 6 months before randomisation
- •Symptomatic carotid stenosis, atrioventricular (AV) block, QT-prolongation, atrial fibrillation, sinus node disease (such as sick sinus syndrome or symptomatic bradycardia), chronic obstructive pulmonary disease (COPD) or asthma
研究组 & 干预措施
1
Active Comparator
干预措施: Rosuvastatin (Drug)
2
Placebo Comparator
干预措施: Placebo (Drug)
结局指标
主要结局
Change in CFR peak velocity within rosuvastatin group after 1 month of treatment compared to baseline
时间窗: Baseline and after 1 month of treatment
Comparison of treatment effects on CFR peak velocities between groups after 1 month of treatment
时间窗: Baseline and after 1 month of treatment
次要结局
- Changes in CFR peak velocity within the rosuvastatin group after 3 months compared to baseline and to 1 month(Bseline, after 1 month and after 3 months of treatment)
- Changes in other CFR parameters after one month rosuvastatin or placebo treatment; comparisons within groups and between groups(Baseline and after 1 month of treatment)
- Changes in plasma lipids, lipoproteins and other cardiovascular biomarkers after 1 month of treatment with rosuvastatin or placebo; comparisons within groups and between groups(Baseline and after 1 month of treatment)
研究者
研究点 (1)
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