NCT00190593已完成3 期
Raloxifene Hydrochloride or Placebo in Postmenopausal Women at Risk for Major Coronary Events
适应症
相关药物
试验速览
- 阶段
- 3 期
- 状态
- 已完成
- 入组人数
- 10,000
- 试验地点
- 1
- 主要终点
- Time to first occurrence of coronary death, non-fatal myocardial infarction (MI), or hospitalized acute coronary syndrome other than MI combined after an expected 5 to 7.5 years of follow-up.
研究概览
简要总结
The purpose of this study is to determine whether raloxifene compared with placebo lowers the risk of coronary events and reduces the risk of invasive breast cancer in postmenopausal women at risk for major coronary events.
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
- 55 Years 至 —（Adult, Older Adult）
- 性别
- Female
- 接受健康志愿者
- 否
入选标准
- •Postmenopausal women with established coronary heart disease or at risk for a major coronary event.
排除标准
- •Postmenopausal symptoms that required estrogen replacement therapy.
- •Suspected or known history of breast or endometrial carcinoma.
- •Known or probable history of deep venous thrombosis, pulmonary embolism, or retinal vein thrombosis.
- •New York Heart Association classes III or IV heart failure.
结局指标
主要结局
Time to first occurrence of coronary death, non-fatal myocardial infarction (MI), or hospitalized acute coronary syndrome other than MI combined after an expected 5 to 7.5 years of follow-up.
Time to first occurrence of invasive breast cancer after an expected 5 to 7.5 years of follow-up.
次要结局
- After an expected 5 to 7.5 years of follow-up:
- Cardiovascular death, non-fatal MI, hospitalized acute coronary syndrome other than MI, myocardial revascularization, and stroke (individually and combined)
- All-cause hospitalization and mortality
- Non-coronary artery revascularization
- Non-traumatic lower extremity amputation
- Fractures
- Venous thromboembolism.
研究者
研究点 (1)
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