NCT02105623终止4 期
EARly Prevention of aTHeroma Progression
CHEOL WHAN LEE, M.D., Ph.D1 个研究点 分布在 1 个国家目标入组 111 人开始时间: 2014年6月最近更新:
适应症
干预措施
相关药物
试验速览
- 阶段
- 4 期
- 状态
- 终止
- 发起方
- 入组人数
- 111
- 试验地点
- 1
- 主要终点
- Percent change in total atheroma volume(TAV)
研究概览
简要总结
The purpose of this study is to compare standard therapy (risk factor control, life style modification) versus standard therapy plus low-dose rosuvastatin therapy (5mg/day) on progression of coronary atherosclerosis in statin naive individuals who have mild CAD (nonobstructive coronary atherosclerotic plaques) and normal LDL (low-density lipoprotein) cholesterol levels(<130mg/dl).
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
- None
入排标准
- 年龄范围
- 35 Years 至 —（Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •Men or women at least 35 years of age
- •Mild CAD (nonobstructive coronary atherosclerotic plaques, lumen narrowing <50%) and CAC score <300 in at least one segment of proximal or mid-portion of major epicardial coronary arteries
- •LDL cholesterol <130mg/dl
排除标准
- •History of stable angina, or acute coronary syndrome
- •History of transient ischemic attack, or stroke
- •Chronic kidney disease (eGFR< 60ml/min)
- •Diabetes mellitus with microvascular complications or insulin therapy
- •Hypertriglyceridemia (triglyceride >500mg/dl)
- •Any statin therapy in the past 4 weeks
- •Planned cardiac surgery or planned major non-cardiac surgery within 6 months.
- •Chronic disease requiring treatment with oral, intravenous, or intra-articular corticosteroids (use of topical, inhaled, or nasal corticosteroids is permissible).
- •A diagnosis of cancer (other than superficial squamous or basal cell skin cancer) in the past 3 years or current treatment for the active cancer.
- •Any clinically significant abnormality identified at the screening visit, physical examination, laboratory tests, or electrocardiogram which, in the judgment of the Investigator, would preclude safe completion of the study.
- •Hepatic disease or biliary tract obstruction, or significant hepatic enzyme elevation (ALT or AST > 3 times upper limit of normal).
- •History of adult asthma manifested by bronchospasm in the past 6 months, or currently taking regular anti-asthmatic medication(s).
- •Unwillingness or inability to comply with the procedures described in this protocol.
- •Positive pregnancy test (all female subjects of childbearing potential must have a urine ß-human chorionic gonadotropin(hCG) pregnancy test performed at Screening and/ or within 7 days prior to randomization) or is known to be pregnant or lactating.
- •Hypersensitivity to Crestor
- •Skeletal muscle disease
- •Combination use with cyclosporine
- •Galactose intolerance, Lapp lactose deficiency or glucose-galactose malabsorption
- •Combination use of protease inhibitor
研究组 & 干预措施
Standard Therapy
Active Comparator
Risk factor control Diet Exercise
干预措施: Standard Therapy (Behavioral)
Rosuvastatin therapy
Experimental
Risk factor control Rosuvastatin
干预措施: Rosuvastatin (Drug)
结局指标
主要结局
Percent change in total atheroma volume(TAV)
时间窗: 2 years
Percent change in total atheroma volume(TAV) at region of interest defined as(TAV at 24 months-TAV at baseline)/(TAV at baseline)x 100
次要结局
- Change in overall TAV(2years)
- Change in number of segment of any coronary atherosclerotic plaques(2years)
- Percent change from baseline in lipid levels(2years)
- Change in PAV(Percent atheroma volume) at region of interest(2years)
- Change in TAV at region of interest(2years)
- Change in overall CAC(coronary artery calcification) score(2years)
研究者
CHEOL WHAN LEE, M.D., Ph.D
MD
Asan Medical Center
研究点 (1)
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