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Trial NCT00000605

Resource URI: http://static.linkedct.org/resource/trials/NCT00000605
linkedct:brief_title Estrogen and Graft Atherosclerosis Research Trial (EAGER)
linkedct:condition <http://static.linkedct.org/resource/condition/10439>
linkedct:condition <http://static.linkedct.org/resource/condition/2312>
linkedct:condition <http://static.linkedct.org/resource/condition/3361>
linkedct:condition <http://static.linkedct.org/resource/condition/3388>
linkedct:condition <http://static.linkedct.org/resource/condition/5702>
linkedct:condition <http://static.linkedct.org/resource/condition/8489>
linkedct:criteria Postmenopausal women who had undergone coronary artery bypass graft.
linkedct: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.
linkedct:download_date Information obtained from ClinicalTrials.gov on December 30, 2009
linkedct:eligibility_gender Female
linkedct:eligibility_healthy_volunteers No
linkedct:eligibility_maximum_age 75 Years
linkedct:eligibility_minimum_age 45 Years
linkedct:end_date July 2002
linkedct:enrollment 0 (xsd:int)
linkedct:firstreceived_date October 27, 1999
linkedct:id NCT00000605
rdfs:label Trial NCT00000605
linkedct:lastchanged_date June 23, 2005
linkedct:lead_sponsor_agency National Heart, Lung, and Blood Institute (NHLBI)
linkedct:nct_id NCT00000605
linkedct:number_of_arms 0 (xsd:int)
linkedct:number_of_groups 0 (xsd:int)
linkedct:org_study_id 109
linkedct:overall_official <http://static.linkedct.org/resource/overall_official/45004>
linkedct:overall_status Completed
linkedct:oversight <http://static.linkedct.org/resource/oversight/2918>
foaf:page <http://clinicaltrials.gov/show/NCT00000605>
linkedct:phase Phase 3
linkedct:source National Heart, Lung, and Blood Institute (NHLBI)
linkedct:start_date August 1996
linkedct:study_design Prevention, Randomized, Double-Blind, Placebo Control
linkedct:study_type Interventional
linkedct:summary 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.
rdf:type linkedct:trials
linkedct:verification_date April 2005