Overview

The Estrogen Replacement and Atherosclerosis Trial ; Primary Outcome Measure is Mean Minimal Coronary Artery Diameter After Avg of 3.2 Yrs.

Status:
Completed

Trial end date:
2001-01-01

Target enrollment:

Participant gender:

Summary

Background: Heart disease is a major cause of illness and death in women. To understand better the role of estrogen in the treatment and prevention of heart disease, more information is needed about its effects on coronary atherosclerosis and the extent to which concomitant progestin therapy may modify these effects. Methods: The investigators randomly assigned a total of 309 women with angiographically verified coronary disease to receive 0.625 mg of conjugated estrogen per day, 0.625 mg of conjugated estrogen plus 2.5 mg of medroxyprogesterone acetate per day, or placebo. The women were followed for a mean (±SD) of 3.2±0.6 years. Base-line and follow-up coronary angiograms were were analyzed by quantitative methods. Follow-up coronary angiograms were obtained after an average of 3.2 years of follow up.

Phase:

Phase 3

Details

Lead Sponsor:

Wake Forest University Health Sciences

Collaborator:

National Heart, Lung, and Blood Institute (NHLBI)

Treatments:

Estrogens
Estrogens, Conjugated (USP)
Medroxyprogesterone
Medroxyprogesterone Acetate