The Estrogen Replacement and Atherosclerosis Trial
试验速览
- 阶段
- 3 期
- 状态
- 已完成
- 入组人数
- 309
- 试验地点
- 1
- 主要终点
- mean minimal coronary-artery diameter
研究概览
简要总结
Background: Heart disease is a major cause of illness and death in women. To understand better the role of estrogen in the treatment and prevention of heart disease, more information is needed about its effects on coronary atherosclerosis and the extent to which concomitant progestin therapy may modify these effects.
Methods: The investigators randomly assigned a total of 309 women with angiographically verified coronary disease to receive 0.625 mg of conjugated estrogen per day, 0.625 mg of conjugated estrogen plus 2.5 mg of medroxyprogesterone acetate per day, or placebo. The women were followed for a mean (±SD) of 3.2±0.6 years. Base-line and follow-up coronary angiograms were were analyzed by quantitative methods. Follow-up coronary angiograms were obtained after an average of 3.2 years of follow up.
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
- Quadruple (Participant, Care Provider, Investigator, Outcomes Assessor)
入排标准
- 年龄范围
- 55 Years 至 —（Adult, Older Adult）
- 性别
- Female
- 接受健康志愿者
- 否
入选标准
- •postmenopausal
- •not currently receiving estrogen-replacement treatment
- •one or more epicardial coronary stenoses of at least 30 percent of the luminal diameter, as measured by quantitative coronary angiography
排除标准
- •known or suspected breast or endometrial carcinoma
- •previous or planned coronary-artery bypass surgery,
- •a history of deep-vein thrombosis or pulmonary embolism,
- •symptomatic gallstones,
- •serum aspartate aminotransferase level more than 1.5 times the normal value,
- •fasting triglyceride level of more than 400 mg per deciliter
- •serum creatinine level of more than 2.0 mg per deciliter
- •more than 70 percent stenosis of the left main coronary artery,
- •uncontrolled hypertension, or
- •uncontrolled diabetes.
研究组 & 干预措施
unopposed estrogen
0.625 mg of conjugated equine estrogen
干预措施: 0.625 mg of conjugated equine estrogen (Drug)
estrogen-plus-medroxyprogesterone
0.625 mg of conjugated equine estrogen plus 2.5 mg of medroxyprogesterone acetate
干预措施: 0.625 mg of conjugated equine estrogen plus 2.5 mg of medroxyprogesterone acetate (Drug)
placebo
placebo
干预措施: placebo tablets (Drug)
结局指标
主要结局
mean minimal coronary-artery diameter
时间窗: at average of 3.2 years follow-up
mean minimal coronary-artery diameter within each subject at follow-up, analyzed on an intention-to-treat basis
次要结局
- stenosis as a percentage of the reference diameter(at average of 3.2 years follow-up)
- development of new lesions in a patient(at average of 3.2 years follow-up)
- Models focusing on change in diameter were also examined(at average of 3.2 years follow-up)