The Estrogen Replacement and Atherosclerosis Trial ; Primary Outcome Measure is Mean Minimal Coronary Artery Diameter After Avg of 3.2 Yrs.

Study Overview
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Brief Summary
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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.

Official Title
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The Estrogen Replacement and Atherosclerosis Trial

Conditions
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Heart Disease

Intervention / Treatment
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* Drug: 0.625 mg of conjugated equine estrogen
* Drug: 0.625 mg of conjugated equine estrogen plus 2.5 mg of medroxyprogesterone acetate
* Drug: placebo tablets


Participation Criteria
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Eligibility Criteria
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Inclusion Criteria: 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 Exclusion Criteria: 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.

Ages Eligible for Study
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Minimum Age: 55 Years

Sexes Eligible for Study
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Female

Accepts Healthy Volunteers
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No

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: Quadruple


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Active Comparator: unopposed estrogen<br>0.625 mg of conjugated equine estrogen | Drug: 0.625 mg of conjugated equine estrogen<br>* one tablet containing 0.625 mg of conjugated equine estrogen and a placebo tablet daily<br>|
| Active Comparator: estrogen-plus-medroxyprogesterone<br>0.625 mg of conjugated equine estrogen plus 2.5 mg of medroxyprogesterone acetate | Drug: 0.625 mg of conjugated equine estrogen plus 2.5 mg of medroxyprogesterone acetate<br>* one tablet of 0.625 mg of conjugated equine estrogen plus one tablet 2.5 mg of medroxyprogesterone acetate daily<br>|
| Placebo Comparator: placebo<br>placebo | Drug: placebo tablets<br>* two placebo tablets daily<br>|

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| mean minimal coronary-artery diameter | mean minimal coronary-artery diameter within each subject at follow-up, analyzed on an intention-to-treat basis | at average of 3.2 years follow-up | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| 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 |