Estrogen Replacement and Atherosclerosis (ERA) in Older Women
Condition: Cardiovascular Diseases; Coronary Arteriosclerosis; Coronary Disease; Heart Diseases; Myocardial Ischemia; Postmenopause
MeSH terms: Cardiovascular Diseases; Heart Diseases; Coronary Disease; Coronary Artery Disease; Myocardial Ischemia; Arteriosclerosis; Ischemia
Study type: Interventional
Phase: Phase 3

Summary: 
      To determine if estrogen replacement therapy, with or without low dose progesterone, slows
      progression or induces regression of coronary atherosclerosis in postmenopausal women.
    

Detailed description: 
      BACKGROUND:

      Cardiovascular disease is the number one cause of death in postmenopausal women.
      Postmenopausal estrogen replacement is associated with a lower incidence of cardiovascular
      disease in women, especially in those with established coronary artery disease. The strength
      of the apparent effect of estrogen in epidemiologic studies suggests that estrogen plays a
      fundamental role in the maintenance of vascular health. Animal data suggest that the current
      practice of adding the low dose progesterone to prevent endometrial hyperplasia may inhibit
      the beneficial effects of estrogen on coronary arteries. Before committing millions of
      postmenopausal women to long-term estrogen use for prevention of coronary artery disease, it
      is mandatory to demonstrate that it does indeed protect against coronary atherosclerosis, to
      determine the impact of co-treatment with progestin, and to understand the mechanisms through
      which estrogen may exert it's cardioprotective effects.

      The Office of Research on Women's Health provided $500,000 in Fiscal Year 1995 for
      recruitment of subjects.

      DESIGN NARRATIVE:

      Randomized, placebo-controlled, blinded. The minimum diameter of coronary stenotic lesions
      was measured by angiography before and after three years in a group receiving unopposed
      estrogen replacement therapy, a group receiving estrogen replacement plus continuous low dose
      progestin, and a group receiving placebo. The incidence of clinical events was documented in
      all three groups. Secondary objectives of the trial included examining the effect of chronic
      and acute estrogen administration on endothelium-dependent coronary vasodilator capacity,
      plasma lipids and lipoproteins, antioxidant activity, blood pressure, glucose metabolism, and
      plasma hemostatic factors, as well as on behaviors, physical attributes, and psychosocial
      parameters. There were four pre-randomization variables in order to pre-stratify. These
      included current smoking status, insulin dependent diabetes, current lipid-lowering therapy,
      and the hospital where angiograms were performed.

      The study completion date listed in this record was obtained from the "End Date" entered in
      the Protocol Registration and Results System (PRS) record.
    

Intervention name(s): estrogen replacement therapy; hormone replacement therapy; estrogens; progestins
Intervention type(s): Drug; Drug; Drug; Drug
Intervention MeSH terms: Hormones; Estrogens; Progestins
Allocation: Randomized
Primary purpose: Prevention