EPAT: Estrogen in the Prevention of Atherosclerosis Trial

This study has been completed.
Sponsor:
Collaborator:
Mead Johnson Nutrition
Information provided by:
National Institute on Aging (NIA)
ClinicalTrials.gov Identifier:
NCT00115024
First received: June 20, 2005
Last updated: December 9, 2009
Last verified: June 2005
  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 2
Phase 3

Study Type: Interventional
Study Design: Allocation: Randomized
Endpoint Classification: Efficacy Study
Intervention Model: Parallel Assignment
Masking: Double-Blind
Primary Purpose: Prevention
Official Title: Estrogen in the Prevention of Atherosclerosis Trial

Resource links provided by NLM:


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
Study Completion Date: November 1998
Primary Completion Date: November 1998 (Final data collection date for primary outcome measure)
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
Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the Contacts provided below. For general information, see Learn About Clinical Studies.

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
Mead Johnson Nutrition
Investigators
Principal Investigator: Howard N. Hodis, MD University of Southern California, Atherosclerosis Research Unit, Division of Cardiovascular Medicine, Department of Medicine
  More Information

Publications:
Additional publications automatically indexed to this study by ClinicalTrials.gov Identifier (NCT Number):
ClinicalTrials.gov Identifier: NCT00115024     History of Changes
Other Study ID Numbers: AG0026, R01AG18798
Study First Received: June 20, 2005
Last Updated: December 9, 2009
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:
Atherosclerosis
Arteriosclerosis
Arterial Occlusive Diseases
Vascular Diseases
Cardiovascular Diseases
Estradiol
Estrogens
Hormones
Hormones, Hormone Substitutes, and Hormone Antagonists
Physiological Effects of Drugs
Pharmacologic Actions

ClinicalTrials.gov processed this record on August 20, 2014