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Estrogen Replacement and Atherosclerosis (ERA) in Older Women

This study has been completed.
Sponsor:
ClinicalTrials.gov Identifier:
NCT00000549
First Posted: October 28, 1999
Last Update Posted: March 16, 2016
The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details.
Information provided by:
National Heart, Lung, and Blood Institute (NHLBI)
  Purpose
To determine if estrogen replacement therapy, with or without low dose progesterone, slows progression or induces regression of coronary atherosclerosis in postmenopausal women.

Condition Intervention Phase
Cardiovascular Diseases Coronary Arteriosclerosis Coronary Disease Heart Diseases Myocardial Ischemia Postmenopause Drug: estrogen replacement therapy Drug: hormone replacement therapy Drug: estrogens Drug: progestins Phase 3

Study Type: Interventional
Study Design: Allocation: Randomized
Primary Purpose: Prevention

Resource links provided by NLM:


Further study details as provided by National Heart, Lung, and Blood Institute (NHLBI):

Study Start Date: August 1994
Study Completion Date: July 2000
Detailed Description:

BACKGROUND:

Cardiovascular disease is the number one cause of death in postmenopausal women. Postmenopausal estrogen replacement is associated with a lower incidence of cardiovascular disease in women, especially in those with established coronary artery disease. The strength of the apparent effect of estrogen in epidemiologic studies suggests that estrogen plays a fundamental role in the maintenance of vascular health. Animal data suggest that the current practice of adding the low dose progesterone to prevent endometrial hyperplasia may inhibit the beneficial effects of estrogen on coronary arteries. Before committing millions of postmenopausal women to long-term estrogen use for prevention of coronary artery disease, it is mandatory to demonstrate that it does indeed protect against coronary atherosclerosis, to determine the impact of co-treatment with progestin, and to understand the mechanisms through which estrogen may exert it's cardioprotective effects.

The Office of Research on Women's Health provided $500,000 in Fiscal Year 1995 for recruitment of subjects.

DESIGN NARRATIVE:

Randomized, placebo-controlled, blinded. The minimum diameter of coronary stenotic lesions was measured by angiography before and after three years in a group receiving unopposed estrogen replacement therapy, a group receiving estrogen replacement plus continuous low dose progestin, and a group receiving placebo. The incidence of clinical events was documented in all three groups. Secondary objectives of the trial included examining the effect of chronic and acute estrogen administration on endothelium-dependent coronary vasodilator capacity, plasma lipids and lipoproteins, antioxidant activity, blood pressure, glucose metabolism, and plasma hemostatic factors, as well as on behaviors, physical attributes, and psychosocial parameters. There were four pre-randomization variables in order to pre-stratify. These included current smoking status, insulin dependent diabetes, current lipid-lowering therapy, and the hospital where angiograms were performed.

The study completion date listed in this record was obtained from the "End Date" entered in the Protocol Registration and Results System (PRS) record.

  Eligibility

Information from the National Library of Medicine

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Ages Eligible for Study:   45 Years to 75 Years   (Adult, Senior)
Sexes Eligible for Study:   Female
Accepts Healthy Volunteers:   No
Criteria
Postmenopausal women with established coronary atherosclerosis.
  Contacts and Locations
Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT00000549


Sponsors and Collaborators
National Heart, Lung, and Blood Institute (NHLBI)
Investigators
OverallOfficial: David Herrington Bowman Gray School of Medicine
  More Information

Publications:
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. Erratum in: Control Clin Trials 2000 Aug;21(4):414.
Folmar S, Oates-Williams F, Sharp P, Reboussin D, Smith J, Cheshire K, Macer J, Potvin Klein K, Herrington D. Recruitment of participants for the Estrogen Replacement and Atherosclerosis (ERA) trial. a comparison of costs, yields, and participant characteristics from community- and hospital-based recruitment strategies. Control Clin Trials. 2001 Feb;22(1):13-25.
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.
Erkkilä AT, Lichtenstein AH, Mozaffarian D, Herrington DM. Fish intake is associated with a reduced progression of coronary artery atherosclerosis in postmenopausal women with coronary artery disease. Am J Clin Nutr. 2004 Sep;80(3):626-32.
Herrington DM, Howard TD, Hawkins GA, Reboussin DM, Xu J, Zheng SL, Brosnihan KB, Meyers DA, Bleecker ER. Estrogen-receptor polymorphisms and effects of estrogen replacement on high-density lipoprotein cholesterol in women with coronary disease. N Engl J Med. 2002 Mar 28;346(13):967-74.
Lakoski SG, Brosnihan B, Herrington DM. Hormone therapy, C-reactive protein, and progression of atherosclerosis: data from the Estrogen Replacement on Progression of Coronary Artery Atherosclerosis (ERA) trial. Am Heart J. 2005 Nov;150(5):907-11.

ClinicalTrials.gov Identifier: NCT00000549     History of Changes
Other Study ID Numbers: 93
U01HL049488 ( U.S. NIH Grant/Contract )
First Submitted: October 27, 1999
First Posted: October 28, 1999
Last Update Posted: March 16, 2016
Last Verified: December 2005

Additional relevant MeSH terms:
Estrogens
Cardiovascular Diseases
Heart Diseases
Ischemia
Coronary Disease
Coronary Artery Disease
Myocardial Ischemia
Arteriosclerosis
Pathologic Processes
Vascular Diseases
Arterial Occlusive Diseases
Hormones
Progestins
Hormones, Hormone Substitutes, and Hormone Antagonists
Physiological Effects of Drugs


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