EPAT: Estrogen in the Prevention of Atherosclerosis Trial

Study Overview
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Brief Summary
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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).

Detailed Description
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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.

Official Title
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Estrogen in the Prevention of Atherosclerosis Trial

Conditions
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Atherosclerosis, Postmenopause

Intervention / Treatment
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* Drug: Micronized 17B-estradiol


Participation Criteria
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Eligibility Criteria
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Inclusion Criteria: 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 Exclusion Criteria: 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.

Ages Eligible for Study
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Minimum Age: 46 Years
Maximum Age: 80 Years

Sexes Eligible for Study
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Female

Accepts Healthy Volunteers
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Accepts Healthy Volunteers

Study Plan
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How is the study designed?
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Design Details

Primary Purpose: Prevention
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Double


Arms and Interventions

| Intervention/Treatment |
| --- |
|Drug: Micronized 17B-estradiol|nan|

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| rate of change of distal common carotid artery (CCA) far wall intima-media thickness (IMT) |  |  | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| lipid and non-lipid factors |  |  | 

 Terms related to the study
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Keywords Provided by Centre Hospitalier Valida
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postmenopausal, estrogen, cardiovascular disease, CVD, cholesterol, LDL, lipids