EPAT: Estrogen in the Prevention of Atherosclerosis Trial
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).
Drug: Micronized 17B-estradiol
|Study Design:||Allocation: Randomized
Endpoint Classification: Efficacy Study
Intervention Model: Parallel Assignment
Primary Purpose: Prevention
|Official Title:||Estrogen in the Prevention of Atherosclerosis Trial|
- rate of change of distal common carotid artery (CCA) far wall intima-media thickness (IMT)
- lipid and non-lipid factors
|Study Start Date:||April 1994|
|Study Completion Date:||November 1998|
|Primary Completion Date:||November 1998 (Final data collection date for primary outcome measure)|
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.
Please refer to this study by its ClinicalTrials.gov identifier: NCT00115024
|United States, California|
|Atherosclerosis Research Unit, Division of Cardiovascular Medicine, Department of Medicine|
|Los Angeles, California, United States, 90033|
|Principal Investigator:||Howard N. Hodis, MD||University of Southern California, Atherosclerosis Research Unit, Division of Cardiovascular Medicine, Department of Medicine|