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

Heart Disease Clinical Trial

— ERA  

Official title:

The Estrogen Replacement and Atherosclerosis Trial

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT03097120
• Other study ID #: U01HL45488
• Status: Completed
• Phase: Phase 3
• Start date: January 1995
• Est. completion date: January 2001

Study information

• Verified date: July 2018
• Source: Wake Forest University Health Sciences
• Contact: n/a
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial 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.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 309
• Est. completion date: January 2001
• Est. primary completion date: January 2001
• Accepts healthy volunteers: No
• Gender: Female
• Age group: 55 Years and older

Eligibility

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.

Related Conditions & MeSH terms

• Atherosclerosis
• Heart Disease
• Heart Diseases

Intervention

Drug:
• 0.625 mg of conjugated equine estrogen
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
one tablet of 0.625 mg of conjugated equine estrogen plus one tablet 2.5 mg of medroxyprogesterone acetate daily
• placebo tablets
two placebo tablets daily

Locations

Country	Name	City	State
United States	Wake Forest University School of Medicine	Winston-Salem	North Carolina

Sponsors (2)

Lead Sponsor	Collaborator
Wake Forest University Health Sciences	National Heart, Lung, and Blood Institute (NHLBI)

Country where clinical trial is conducted

United States, 

References & Publications (2)

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 Au — View 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. Erratum In: Control Clin Trials 2000 Aug;21(4):414. — View Citation

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	mean minimal coronary-artery diameter	mean minimal coronary-artery diameter within each subject at follow-up, analyzed on an intention-to-treat basis	at average of 3.2 years follow-up
Secondary	stenosis as a percentage of the reference diameter		at average of 3.2 years follow-up
Secondary	development of new lesions in a patient		at average of 3.2 years follow-up
Secondary	Models focusing on change in diameter were also examined		at average of 3.2 years follow-up