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

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

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Recruitment Status

COMPLETED

Clinical Phase

PHASE3

Total Enrollment

309 participants

Study Classification

INTERVENTIONAL

Study Start Date

1995-01-31

Study Completion Date

2001-01-31

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.

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Detailed Description

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Conditions

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Heart Disease

Study Design

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Allocation Method

RANDOMIZED

Intervention Model

PARALLEL

Primary Study Purpose

PREVENTION

Blinding Strategy

QUADRUPLE

Participants Caregivers Investigators Outcome Assessors

Study Groups

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unopposed estrogen

0.625 mg of conjugated equine estrogen

Group Type ACTIVE_COMPARATOR

0.625 mg of conjugated equine estrogen

Intervention Type DRUG

one tablet containing 0.625 mg of conjugated equine estrogen and a placebo tablet daily

estrogen-plus-medroxyprogesterone

0.625 mg of conjugated equine estrogen plus 2.5 mg of medroxyprogesterone acetate

Group Type ACTIVE_COMPARATOR

0.625 mg of conjugated equine estrogen plus 2.5 mg of medroxyprogesterone acetate

Intervention Type DRUG

one tablet of 0.625 mg of conjugated equine estrogen plus one tablet 2.5 mg of medroxyprogesterone acetate daily

placebo

Group Type PLACEBO_COMPARATOR

placebo tablets

Intervention Type DRUG

two placebo tablets daily

Interventions

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0.625 mg of conjugated equine estrogen

one tablet containing 0.625 mg of conjugated equine estrogen and a placebo tablet daily

Intervention Type DRUG

0.625 mg of conjugated equine estrogen plus 2.5 mg of medroxyprogesterone acetate

one tablet of 0.625 mg of conjugated equine estrogen plus one tablet 2.5 mg of medroxyprogesterone acetate daily

Intervention Type DRUG

placebo tablets

two placebo tablets daily

Intervention Type DRUG

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.

Minimum Eligible Age

55 Years

Eligible Sex

FEMALE

Accepts Healthy Volunteers

No