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Estrogen and Graft Atherosclerosis Research Trial (EAGER)

This study has been completed.
Sponsor:
ClinicalTrials.gov Identifier:
NCT00000605
First Posted: October 28, 1999
Last Update Posted: February 18, 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 postmenopausal hormone replacement therapy in women following coronary bypass surgery would reduce the occurrence of graft occlusion and delay the development of graft atherosclerosis.

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

Study Type: Interventional
Study Design: Allocation: Randomized
Masking: Double
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 1996
Study Completion Date: July 2002
Detailed Description:

BACKGROUND:

Coronary atherosclerosis is a major cause of death in women in the United States. Although coronary artery bypass surgery decreases symptomatic and clinical evidence of ischemia, it does not alter the underlying process. Patients may present several years later with recurrent symptoms that may be a result of occlusion of saphenous vein grafts, development of atherosclerotic disease in vein grafts, or progression of underlying disease. Any intervention that can reduce the rate of progression of coronary atherosclerosis following bypass surgery would provide significant benefit for women following bypass surgery and possibly for other women with atherosclerotic disease. Observational studies suggest that postmenopausal estrogen replacement therapy is associated with a reduction in cardiac morbidity.

DESIGN NARRATIVE:

The study was a randomized, double-blind, controlled trial. Subjects were randomized to conjugated estrogen with daily medroxyprogesterone or placebo within two weeks of bypass surgery. Graft occlusion and development of vein graft atherosclerosis were measured by comparing quantitative coronary angiographic and vascular ultrasonic assessment of disease severity and extent performed at six months and three and a half years after randomization. The primary outcome variables included the occurrence of graft occlusion at six months and the change in severity and extent of atherosclerosis in the saphenous vein grafts over three years. The trial determined the influence of hormone replacement therapy on the primary outcome variables.

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 who had undergone coronary artery bypass graft.
  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): NCT00000605


Sponsors and Collaborators
National Heart, Lung, and Blood Institute (NHLBI)
Investigators
OverallOfficial: Pamela Ouyang Johns Hopkins University
  More Information

ClinicalTrials.gov Identifier: NCT00000605     History of Changes
Other Study ID Numbers: 109
5U01HL050840 ( U.S. NIH Grant/Contract )
First Submitted: October 27, 1999
First Posted: October 28, 1999
Last Update Posted: February 18, 2016
Last Verified: April 2005

Additional relevant MeSH terms:
Cardiovascular Diseases
Heart Diseases
Ischemia
Coronary Disease
Coronary Artery Disease
Myocardial Ischemia
Arteriosclerosis
Pathologic Processes
Vascular Diseases
Arterial Occlusive Diseases
Hormones
Estrogens
Medroxyprogesterone
Medroxyprogesterone Acetate
Hormones, Hormone Substitutes, and Hormone Antagonists
Physiological Effects of Drugs
Contraceptives, Oral, Synthetic
Contraceptives, Oral
Contraceptive Agents, Female
Contraceptive Agents
Reproductive Control Agents
Contraceptive Agents, Male
Antineoplastic Agents, Hormonal
Antineoplastic Agents