Heart Disease
Conditions
Brief 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.
Interventions
DRUG0.625 mg of conjugated equine estrogen
one tablet containing 0.625 mg of conjugated equine estrogen and a placebo tablet daily
DRUG0.625 mg of conjugated equine estrogen plus 2.5 mg of medroxyprogesterone acetate
one tablet of 0.625 mg of conjugated equine estrogen plus one tablet 2.5 mg of medroxyprogesterone acetate daily
DRUGplacebo tablets
two placebo tablets daily
Sponsors
National Heart, Lung, and Blood Institute (NHLBI)
Wake Forest University Health Sciences
Study design
Allocation
RANDOMIZED
Intervention model
PARALLEL
Primary purpose
PREVENTION
Masking
QUADRUPLE (Subject, Caregiver, Investigator, Outcomes Assessor)
Eligibility
Sex/Gender
FEMALE
Age
55 Years to No maximum
Healthy volunteers
No
Inclusion criteria
* postmenopausal * not currently receiving estrogen-replacement treatment * one or more epicardial coronary stenoses of at least 30 percent of the luminal diameter, as measured by quantitative coronary angiography
Exclusion criteria
* known or suspected breast or endometrial carcinoma * previous or planned coronary-artery bypass surgery, * a history of deep-vein thrombosis or pulmonary embolism, * symptomatic gallstones, * serum aspartate aminotransferase level more than 1.5 times the normal value, * fasting triglyceride level of more than 400 mg per deciliter * serum creatinine level of more than 2.0 mg per deciliter * more than 70 percent stenosis of the left main coronary artery, * uncontrolled hypertension, or * uncontrolled diabetes.
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| mean minimal coronary-artery diameter | at average of 3.2 years follow-up | mean minimal coronary-artery diameter within each subject at follow-up, analyzed on an intention-to-treat basis |
Secondary
| Measure | Time frame |
|---|---|
| stenosis as a percentage of the reference diameter | at average of 3.2 years follow-up |
| development of new lesions in a patient | at average of 3.2 years follow-up |
| Models focusing on change in diameter were also examined | at average of 3.2 years follow-up |
Countries
United States
Outcome results
None listed