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OpenTrials
Completed

NCT Number: NCT03097120

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

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.

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Key information

Conditions

Heart Disease Cardiovascular Diseases Heart Diseases

Age range

55 year and older

Sex eligibility

Female

Study type

Interventional

Phase

Phase 3

Primary location

Wake Forest University School of Medicine

Winston-Salem, North Carolina, 27157, United States

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

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.

Treatment and study plan

0.625 mg of conjugated equine estrogen

Drug

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

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

Drug

one tablet of 0.625 mg of conjugated equine estrogen plus one tablet 2.5 mg of medroxyprogesterone acetate daily

Placebo tablets

Drug

two placebo tablets daily

Primary outcomes

  1. mean minimal coronary-artery diameter

    Time frame: 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 outcomes

  1. stenosis as a percentage of the reference diameter

    Time frame: at average of 3.2 years follow-up

  2. development of new lesions in a patient

    Time frame: at average of 3.2 years follow-up

  3. Models focusing on change in diameter were also examined

    Time frame: at average of 3.2 years follow-up

Sponsors and collaborators

Lead sponsor

Wake Forest University Health Sciences

Other

Collaborators

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

Registry information

Official study title

The Estrogen Replacement and Atherosclerosis Trial

Acronym: ERA

Important dates

Study start
1995
Primary completion
2001
Study completion
2001
First posted
Mar 31, 2017
Registry last updated
May 22, 2023

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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