EPAT: Estrogen in the Prevention of Atherosclerosis Trial

Sponsor

National Institute on Aging (NIA) (NIH)

Overall Status

Completed

CT.gov ID

NCT00115024

Collaborator

Mead Johnson Nutrition (Industry)

222

Enrollment

Location

Duration (Months)

Patients Per Site Per Month

Study Details

Study Description

Brief Summary

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 or Disease	Intervention/Treatment	Phase
Atherosclerosis Postmenopause	Drug: Micronized 17B-estradiol	Phase 2/Phase 3

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.

Study Design

Study Type:

Interventional

Allocation:

Randomized

Intervention Model:

Parallel Assignment

Masking:

Double

Primary Purpose:

Prevention

Official Title:

Estrogen in the Prevention of Atherosclerosis Trial

Study Start Date :

Apr 1, 1994

Actual Primary Completion Date :

Nov 1, 1998

Actual Study Completion Date :

Nov 1, 1998

Outcome Measures

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 []

Eligibility Criteria

Criteria

Ages Eligible for Study:

46 Years to 80 Years

Sexes Eligible for Study:

Female

Accepts Healthy Volunteers:

Yes

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

Locations

	Site	City	State	Country	Postal Code
1	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 Nutrition

Investigators

Principal Investigator: Howard N. Hodis, MD, University of Southern California, Atherosclerosis Research Unit, Division of Cardiovascular Medicine, Department of Medicine