EPAT: Estrogen in the Prevention of Atherosclerosis Trial

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

PHASE2/PHASE3

Total Enrollment

222 participants

Study Classification

INTERVENTIONAL

Study Start Date

1994-04-30

Study Completion Date

1998-11-30

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.

Conditions

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Atherosclerosis Postmenopause

Keywords

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cardiovascular disease CVD estrogen cholesterol LDL lipids postmenopausal

Study Design

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Allocation Method

RANDOMIZED

Intervention Model

PARALLEL

Primary Study Purpose

PREVENTION

Blinding Strategy

DOUBLE

Interventions

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Micronized 17B-estradiol

Intervention Type DRUG

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.

Minimum Eligible Age

46 Years

Maximum Eligible Age

80 Years

Eligible Sex

FEMALE

Accepts Healthy Volunteers

Yes

Principal Investigators

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Howard N. Hodis, MD

Role: PRINCIPAL_INVESTIGATOR

University of Southern California, Atherosclerosis Research Unit, Division of Cardiovascular Medicine, Department of Medicine

Locations

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Atherosclerosis Research Unit, Division of Cardiovascular Medicine, Department of Medicine

Los Angeles, California, United States

Site Status

Countries

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United States

References

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Hodis HN, Mack WJ, Lobo RA, Shoupe D, Sevanian A, Mahrer PR, Selzer RH, Liu Cr CR, Liu Ch CH, Azen SP; Estrogen in the Prevention of Atherosclerosis Trial Research Group. Estrogen in the prevention of atherosclerosis. A randomized, double-blind, placebo-controlled trial. Ann Intern Med. 2001 Dec 4;135(11):939-53. doi: 10.7326/0003-4819-135-11-200112040-00005.

Reference Type RESULT

PMID: 11730394 (View on PubMed)

Steiner AZ, Xiang M, Mack WJ, Shoupe D, Felix JC, Lobo RA, Hodis HN. Unopposed estradiol therapy in postmenopausal women: results from two randomized trials. Obstet Gynecol. 2007 Mar;109(3):581-7. doi: 10.1097/01.AOG.0000251518.56369.eb.

Reference Type DERIVED

PMID: 17329508 (View on PubMed)

Other Identifiers

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R01AG018798

Identifier Type: NIH

Identifier Source: secondary_id

View Link

AG0026

Identifier Type: -

Identifier Source: org_study_id