Clinical trial NCT03097120: The Estrogen Replacement and Atherosclerosis Trial ; Primary Outcome Measure is Mean Minimal Coronary Artery Diameter After Avg of 3.2 Yrs.
Official title: The Estrogen Replacement and Atherosclerosis Trial
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: PHASE3
Conditions: Heart Disease
Lead sponsor: Wake Forest University Health Sciences
Sponsor class: OTHER
Collaborators: name: National Heart, Lung, and Blood Institute (NHLBI)
First posted: 2017-03-31
Enrollment: 309
Sex: FEMALE
Minimum age (years): 55
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: PREVENTION

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.


Eligibility criteria: 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.

Primary outcomes:
measure: mean minimal coronary-artery diameter
timeFrame: at average of 3.2 years follow-up
Secondary outcomes:
measure: stenosis as a percentage of the reference diameter
timeFrame: at average of 3.2 years follow-up
measure: development of new lesions in a patient
timeFrame: at average of 3.2 years follow-up
measure: Models focusing on change in diameter were also examined
timeFrame: at average of 3.2 years follow-up
Other outcomes:
Locations:
city: Winston-Salem
country: United States
facility: Wake Forest University School of Medicine
state: North Carolina
Study officials:
affiliation: Wake Forest University Health Sciences
name: David M. Herrington, MD, MHS
role: PRINCIPAL_INVESTIGATOR
References:
citation: Herrington DM, Reboussin DM, Klein KP, Sharp PC, Shumaker SA, Snyder TE, Geisinger KR. The estrogen replacement and atherosclerosis (ERA) study: study design and baseline characteristics of the cohort. Control Clin Trials. 2000 Jun;21(3):257-85. doi: 10.1016/s0197-2456(00)00054-4.
citation: Herrington DM, Reboussin DM, Brosnihan KB, Sharp PC, Shumaker SA, Snyder TE, Furberg CD, Kowalchuk GJ, Stuckey TD, Rogers WJ, Givens DH, Waters D. Effects of estrogen replacement on the progression of coronary-artery atherosclerosis. N Engl J Med. 2000 Aug 24;343(8):522-9. doi: 10.1056/NEJM200008243430801.