NCT02245087终止2 期
Eliminate Coronary Artery Disease
适应症
干预措施
相关药物
试验速览
- 阶段
- 2 期
- 状态
- 终止
- 入组人数
- 28
- 试验地点
- 3
- 主要终点
- Time to first occurrence of myocardial infarction, revascularization, stroke or death from any cause in the follow up period
研究概览
简要总结
The purpose of this study is to determine whether pharmacologic lowering of low density lipoprotein cholesterol (LDL), initiated in healthy young to middle aged adults can eliminate or markedly reduce the composite endpoint of incident all cause mortality, myocardial infarction, stroke or coronary revascularization.
研究设计
- 研究类型
- Interventional
- 分配方式
- Randomized
- 干预模型
- Parallel
- 主要目的
- Prevention
- 盲法
- None
入排标准
- 年龄范围
- 35 Years 至 59 Years（Adult）
- 性别
- All
- 接受健康志愿者
- 是
入选标准
- •Men 35-50 years of age
- •Women 45 - 59 years of age (must be sterile or >2 years postmenopausal)
- •LDL cholesterol greater than 1.8 mmol/L (70 mg/dL) based on testing performed within 1 year
- •One risk factor for Coronary Heart Disease other than lipid abnormality:
- •Obesity and hypertension [BP >140 mmHg systolic and waist circumference > 100 cm in men and >90 cm in women]
- •family history of premature myocardial infarction [<60 years]
- •South Asian ethnic history
- •currently smoking
排除标准
- •Currently taking cholesterol lowering medication
- •Qualify for cholesterol lowering medication based on current guidelines
- •Significant renal dysfunction (creatinine clearance <30 ml/min)
- •Significant hepatic dysfunction (AST/ALT >2.0 times upper limit of normal)
- •Active malignancy
- •Progressive or terminal illness, or other condition in which subject is unlikely to survive the study period
- •Known allergy, hypersensitivity (anaphylaxis) ar adverse reaction to any statin
- •Participation in a clinical trial (except observational studies) within previous 30 days
- •Received any investigation product within 30 days prior to participation in this clinical trial
- •Previously enrolled in this clinical trial
研究组 & 干预措施
Atorvastatin
Experimental
Atorvastatin(Lipitor) in addition to the usual guideline based care
干预措施: Atorvastatin (Drug)
结局指标
主要结局
Time to first occurrence of myocardial infarction, revascularization, stroke or death from any cause in the follow up period
时间窗: Up to 10 years
次要结局
未报告次要终点
研究者
Michael Farkouh
Chair of the Peter Munk Centre of Excellence in Multinational Clinical Trials, Peter Munk Cardiac Centre, UHN
University Health Network, Toronto
研究点 (3)
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