Atherosclerosis Intervention With Novel Tissue Selective Estrogen Complex Therapy
试验速览
- 阶段
- 2 期
- 状态
- 进行中（未招募）
- 入组人数
- 385
- 试验地点
- 2
- 主要终点
- Carotid artery intima-media thickness
研究概览
简要总结
Advancing Postmenopausal Preventive Therapy (APPT) is a randomized, double-blinded, placebo-controlled trial designed to determine the effects of tissue selective estrogen complex (TSEC) therapy on the progression of subclinical atherosclerosis and cognitive decline in 360 healthy postmenopausal women.
详细描述
To conduct a double-blinded, placebo-controlled trial to determine the effects of TSEC therapy on the progression of subclinical atherosclerosis in healthy postmenopausal women. A total of 360 postmenopausal women with a uterus who are within 6 years of menopause and 45-59 years of age and without clinical cardiovascular disease and diabetes mellitus will be randomized to Bazedoxifene/Conjugated Equine Estrogen (BZA 20 mg/CE 0.45 mg) or placebo. Recruitment will occur over 3 years and the treatment period will be up to 3 years depending on when an individual is randomized. Rate of change in carotid artery intima-media thickness (CIMT) determined from the distal common carotid artery (CCA) far wall intima-media thickness (IMT) in computer image processed B mode ultrasonograms will be the primary trial endpoint. Arterial stiffness measured from the CCA (same location as CIMT) in computer image processed B mode ultrasonograms will be the secondary trial endpoint. Three composite cognitive measures will be used to test for randomized treatment group differences in cognition; each composite will be considered as co-endpoints.
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
- Quadruple (Participant, Care Provider, Investigator, Outcomes Assessor)
盲法说明
Randomization randomly determined with key to treatment groups maintained by a single individual in the data coordinating center (DCC); study product masked with matching placebo.
入排标准
- 年龄范围
- 45 Years 至 59 Years（Adult）
- 性别
- Female
- 接受健康志愿者
- 是
入选标准
- •Women with a serum estradiol level <30 pg/ml and cessation of regular menses >6 months who are <6 years postmenopausal and 45-59 years old.
排除标准
- •Women with a hysterectomy
- •Clinical signs, symptoms or personal history of cardiovascular disease
- •Diabetes mellitus or fasting serum glucose >126 mg/dL
- •Life threatening illness with prognosis <5 years
- •Cirrhosis or liver disease
- •History of deep vein thrombosis or pulmonary embolism
- •History of breast cancer
- •Current use of postmenopausal hormone replacement therapy (HRT) within 1 month of randomization
- •Uncontrolled hypertension (>180/>110 mmHg)*
- •Plasma triglyceride levels >500 mg/dL
- •Serum creatinine >2.0 mg/dL
结局指标
主要结局
Carotid artery intima-media thickness
时间窗: At baseline and 6 months, 1 year, 1.5 years, 2 years, 2.5 years and 3 years after randomization
Rate of change in carotid artery intima-media thickness (CIMT) determined from the distal common carotid artery (CCA) far wall intima-media thickness (IMT) in computer image processed B mode ultrasonograms.
次要结局
- CCA stiffness(At baseline and 6 months, 1 year, 1.5 years, 2 years, 2.5 years and 3 years after randomization)
研究者
Howard N. Hodis, M.D.
Professor of Medicine and Preventive Medicine, Director Atherosclerosis Research Unit
University of Southern California