EPAT: Estrogen in the Prevention of Atherosclerosis Trial

Atherosclerosis Clinical Trial

Official title:

Estrogen in the Prevention of Atherosclerosis Trial

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT00115024
• Other study ID #: AG0026
• Secondary ID: R01AG018798
• Status: Completed
• Phase: Phase 2/Phase 3
• First received: June 20, 2005
• Last updated: December 9, 2009
• Start date: April 1994
• Est. completion date: November 1998

Study information

• Verified date: June 2005
• Source: National Institute on Aging (NIA)
• Contact: n/a
• Is FDA regulated: No
• Health authority: United States: Federal Government
• Study type: Interventional

Clinical Trial 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).

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.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 222
• Est. completion date: November 1998
• Est. primary completion date: November 1998
• Accepts healthy volunteers: Accepts Healthy Volunteers
• Gender: Female
• Age group: 46 Years to 80 Years

Eligibility

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.

Study Design

Allocation: Randomized, Endpoint Classification: Efficacy Study, Intervention Model: Parallel Assignment, Masking: Double-Blind, Primary Purpose: Prevention

Related Conditions & MeSH terms

• Atherosclerosis
• Postmenopause

Intervention

Drug:
• Micronized 17B-estradiol

Locations

Country	Name	City	State
United States	Atherosclerosis Research Unit, Division of Cardiovascular Medicine, Department of Medicine	Los Angeles	California

Sponsors (2)

Lead Sponsor	Collaborator
National Institute on Aging (NIA)	Mead Johnson Nutrition

Country where clinical trial is conducted

United States, 

References & Publications (1)

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-c — View Citation

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	rate of change of distal common carotid artery (CCA) far wall intima-media thickness (IMT)
Secondary	lipid and non-lipid factors