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

Sponsor

Wake Forest University Health Sciences (Other)

Overall Status

Completed

CT.gov ID

NCT03097120

Collaborator

National Heart, Lung, and Blood Institute (NHLBI) (NIH)

309

Enrollment

Location

Arms

Duration (Months)

4.3

Patients Per Site Per Month

Study Details

Study Description

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.

Condition or Disease	Intervention/Treatment	Phase
Heart Disease	Drug: 0.625 mg of conjugated equine estrogen Drug: 0.625 mg of conjugated equine estrogen plus 2.5 mg of medroxyprogesterone acetate Drug: placebo tablets	Phase 3

Study Design

Study Type:

Interventional

Actual Enrollment :

309 participants

Allocation:

Randomized

Intervention Model:

Parallel Assignment

Masking:

Quadruple (Participant, Care Provider, Investigator, Outcomes Assessor)

Primary Purpose:

Prevention

Official Title:

The Estrogen Replacement and Atherosclerosis Trial

Study Start Date :

Jan 1, 1995

Actual Primary Completion Date :

Jan 1, 2001

Actual Study Completion Date :

Jan 1, 2001

Arms and Interventions

Arm	Intervention/Treatment
Active Comparator: unopposed estrogen 0.625 mg of conjugated equine estrogen	Drug: 0.625 mg of conjugated equine estrogen one tablet containing 0.625 mg of conjugated equine estrogen and a placebo tablet daily
Active Comparator: estrogen-plus-medroxyprogesterone 0.625 mg of conjugated equine estrogen plus 2.5 mg of medroxyprogesterone acetate	Drug: 0.625 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
Placebo Comparator: placebo placebo	Drug: placebo tablets two placebo tablets daily

Arm

Intervention/Treatment

Active Comparator: unopposed estrogen

0.625 mg of conjugated equine estrogen

Drug: 0.625 mg of conjugated equine estrogen

one tablet containing 0.625 mg of conjugated equine estrogen and a placebo tablet daily

Active Comparator: estrogen-plus-medroxyprogesterone

0.625 mg of conjugated equine estrogen plus 2.5 mg of medroxyprogesterone acetate

Drug: 0.625 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

Placebo Comparator: placebo

placebo

Drug: placebo tablets

two placebo tablets daily

Outcome Measures

Primary Outcome Measures

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 Outcome Measures

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]

Eligibility Criteria

Criteria

Ages Eligible for Study:

55 Years and Older

Sexes Eligible for Study:

Female

Accepts Healthy Volunteers:

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