EPAT: Estrogen in the Prevention of Atherosclerosis Trial - Full Text View

Sponsor:	National Institute on Aging (NIA)
Collaborator:	Mead Johnson
Information provided by:	National Institute on Aging (NIA)
ClinicalTrials.gov Identifier:	NCT00115024

Purpose

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).

Condition	Intervention	Phase
Atherosclerosis Postmenopause	Drug: Micronized 17B-estradiol	Phase II Phase III

Study Type:	Interventional
Study Design:	Prevention, Randomized, Double-Blind, Placebo Control, Parallel Assignment, Efficacy Study
Official Title:	Estrogen in the Prevention of Atherosclerosis Trial

Resource links provided by NLM:

Drug Information available for: Estradiol

U.S. FDA Resources

Further study details as provided by National Institute on Aging (NIA):

Primary Outcome Measures:

rate of change of distal common carotid artery (CCA) far wall intima-media thickness (IMT)

Secondary Outcome Measures:

lipid and non-lipid factors

Estimated Enrollment:	222
Study Start Date:	April 1994
Estimated Study Completion Date:	November 1998

Detailed Description:

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.

Eligibility

Ages Eligible for Study:	46 Years to 80 Years
Genders Eligible for Study:	Female
Accepts Healthy Volunteers:	Yes

Criteria

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.

Contacts and Locations

Please refer to this study by its ClinicalTrials.gov identifier: NCT00115024

Locations

United States, California
Atherosclerosis Research Unit, Division of Cardiovascular Medicine, Department of Medicine
Los Angeles, California, United States, 90033

Sponsors and Collaborators

National Institute on Aging (NIA)

Mead Johnson

Investigators

Principal Investigator:

Howard N. Hodis, MD

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

More Information

Publications:

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.

Additional publications automatically indexed to this study by National Clinical Trials Identifier (NCT ID):

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.

Study ID Numbers:	AG0026, R01AG18798
Study First Received:	June 20, 2005
Last Updated:	June 23, 2005
ClinicalTrials.gov Identifier:	NCT00115024 History of Changes
Health Authority:	United States: Federal Government

Keywords provided by National Institute on Aging (NIA):

cardiovascular disease
CVD
estrogen
cholesterol

LDL
lipids
postmenopausal

Additional relevant MeSH terms:

Arterial Occlusive Diseases
Atherosclerosis
Estrogens
Physiological Effects of Drugs
Hormones, Hormone Substitutes, and Hormone Antagonists

Vascular Diseases
Cardiovascular Diseases
Arteriosclerosis
Hormones
Pharmacologic Actions

ClinicalTrials.gov processed this record on November 27, 2009