NCT00319566已完成3 期
Heart and Estrogen-Progestin Replacement Study (HERS)
适应症
相关药物
试验速览
- 阶段
- 3 期
- 状态
- 已完成
- 入组人数
- 2,430
- 试验地点
- 2
- 主要终点
- Myocardial Infarction
研究概览
简要总结
The purpose of the study is to determine whether hormone replacement therapy in post menopausal women with coronary artery disease prevents future heart attacks or death from coronary heart disease.
详细描述
A randomized, blinded trial in post menopausal women with cornaornary artery disease to test the hypothesis, among 2340 women who have a uterus, that those randomized to receive estrogen-progestin replacement therapy (Premanrin .625 mg daily plus medroxygrprogesterone acetate 2.5 mg daily) have the same frequency on new CHD events (myocardial infarction and CHD death) as those randomized to placebo.
研究设计
- 研究类型
- Interventional
- 分配方式
- Randomized
- 干预模型
- Single Group
- 主要目的
- Prevention
- 盲法
- Double
入排标准
- 年龄范围
- 55 Years 至 75 Years（Adult, Older Adult）
- 性别
- Female
- 接受健康志愿者
- 否
入选标准
- •<75 y.o.
- •uterus present
- •postmenopausal
- •evidence of CHD
- •signed consent
排除标准
- •MI, CABG, mechanical revascularization within 6 months
- •serum triglyceride >300mg/dl
- •used hormone therapy or estrogen vaginal cream in past 3 months
- •history of DVT or pulmonary embolism
- •history of breast cancer or mammogram suggestive of cancer
- •history of endometrial cancer
- •abnormal uterine bleeding
- •pap smear abnormal
- •SGOT more than 1.2 times normal
- •Disease judged to be fatal within 4 yrs
- •alcoholism, drug abuse
- •NYHA Class IV congestive heart failure
- •uncontrolled hypertension
- •uncontrolled diabetes
- •participation in any other investigational study
结局指标
主要结局
Myocardial Infarction
CHD Death
次要结局
- CABG, revascularization, angina
- serum lipids
- quality of life
- compliance
- incidence of uterine bleeding and endometrial hyperplasia
- incidencet and severity of vasomotor and genitourinary symptoms
- adverse effects
- thromboembolic events
- symptomatic gallbladder disease
- fractures
- cancer
- stroke
- peripheral arterial disease
- total mortality
研究者
研究点 (2)
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