Estrogen in the Prevention of Atherosclerosis Trial
试验速览
- 阶段
- 2 期
- 状态
- 已完成
- 发起方
- 入组人数
- 222
- 试验地点
- 2
- 主要终点
- rate of change of distal common carotid artery (CCA) far wall intima-media thickness (IMT)
研究概览
简要总结
The purpose of this study is to determine the effects of estrogen replacement therapy (ERT) on the progression of early atherosclerosis in healthy postmenopausal women without preexisting cardiovascular disease (CVD).
详细描述
The primary goal of this randomized, controlled trial is to determine if ERT stabilizes, retards, and/or reverses the progression of atherosclerosis in postmenopausal women. We will further evaluate the association of lipid and non-lipid factors of ERT-mediated reduction in the progression of early atherosclerosis. Ultrasonography will be used to measure the rate of change in the thickness of the carotid artery. Blood samples will be used for measuring lipid and non-lipid mediators of ERT.
A total of 222 healthy postmenopausal women 46 to 80 years old without CVD symptoms will be randomized to receive either micronized 17B-estradiol (Estrace) 1mg/day, or a matching placebo tablet daily. All women will be on a low fat/low cholesterol diet, and will receive pravastatin if their LDL cholesterol level exceeds 160 mg/dL. Participants will undergo ultrasonography at baseline and every 6 months throughout the 2 years of randomized treatment. Measurements of lipid and non-lipid biochemical markers will also be done at baseline and every 6 months.
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
- Double
入排标准
- 年龄范围
- 46 Years 至 80 Years（Adult, Older Adult）
- 性别
- Female
- 接受健康志愿者
- 是
入选标准
- •Postmenopausal female (serum estradiol less than 20 pg/ml)
- •46 to 80 years old
- •Fasting LDL-C levels 130 to 210 mg/dL
- •Triglyceride levels less than 400 mg/dL
- •Current non-smoker
排除标准
- •Clinical evidence of cardiovascular disease
- •HDL-C level less than 30 mg/dL
- •Fasting blood glucose greater than 200 mg/dL
- •Previous hormonal replacement therapy (non-contraceptive) over 10 years duration and/or current use within 1 month
- •Uncontrolled hypertension
- •Untreated thyroid disease
- •Renal insufficiency
- •Clinical evidence of congestive heart failure
- •Life threatening disease with prognosis less than 5 years
- •Alcohol intake greater than 5 drinks per day (1 drink = 1 1/2 oz distilled spirits, 4 oz wine, or 12 oz beer) or substance abuse (intravenous drug abuse, cocaine use)
- •History of estrogen dependent cancer or detected at screening or any other disorder precluding use of ERT
- •Hot flashes greater than 5 per day which interfere with daily activity and preclude randomization to placebo.
结局指标
主要结局
rate of change of distal common carotid artery (CCA) far wall intima-media thickness (IMT)
次要结局
- lipid and non-lipid factors