Atherosclerosis Clinical Trial
Official title:
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).
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.
;
Allocation: Randomized, Endpoint Classification: Efficacy Study, Intervention Model: Parallel Assignment, Masking: Double-Blind, Primary Purpose: Prevention
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