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

Phase 3

Completed

• Conditions: Heart Disease
• Interventions: 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

• Registration Number: NCT03097120
• Lead Sponsor: Wake Forest University Health Sciences

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.

Detailed Description

Not available

Study Timeline

• Study Start: 1995-01
• Primary Completion: 2001-01
• Study Completion: 2001-01
• Study First Submitted: 2011-04-26
• Study First Submitted QC: 2017-03-24
• Study First Posted: 2017-03-31
• Status Verified: 2018-07
• Last Update Submitted: 2023-05-19
• Last Update Posted: 2023-05-22

Recruitment & Eligibility

• Status: COMPLETED
• Sex: Female
• Target Recruitment: 309

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

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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.

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Study & Design

• Study Type: INTERVENTIONAL
• Study Design: PARALLEL

Arm && Interventions

Group	Intervention	Description
unopposed estrogen	0.625 mg of conjugated equine estrogen	0.625 mg of conjugated equine estrogen
estrogen-plus-medroxyprogesterone	0.625 mg of conjugated equine estrogen plus 2.5 mg of medroxyprogesterone acetate	0.625 mg of conjugated equine estrogen plus 2.5 mg of medroxyprogesterone acetate
placebo	placebo tablets	placebo

Primary Outcome Measures

Name	Time	Method
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

Name	Time	Method
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
stenosis as a percentage of the reference diameter	at average of 3.2 years follow-up

Trial Locations

Locations (1)

Wake Forest University School of Medicine; 🇺🇸 Winston-Salem, North Carolina, United States