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Sponsored by: |
National Heart, Lung, and Blood Institute (NHLBI) |
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Information provided by: | National Heart, Lung, and Blood Institute (NHLBI) |
ClinicalTrials.gov Identifier: | NCT00000605 |
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 III |
Study Type: | Interventional |
Study Design: | Prevention, Randomized, Double-Blind, Placebo Control |
Study Start Date: | August 1996 |
Estimated Study Completion Date: | July 2002 |
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.
Ages Eligible for Study: | 45 Years to 75 Years |
Genders Eligible for Study: | Female |
Accepts Healthy Volunteers: | No |
Postmenopausal women who had undergone coronary artery bypass graft.
Study ID Numbers: | 109 |
Study First Received: | October 27, 1999 |
Last Updated: | June 23, 2005 |
ClinicalTrials.gov Identifier: | NCT00000605 |
Health Authority: | United States: Federal Government |
Arterial Occlusive Diseases Coronary Disease Atherosclerosis Medroxyprogesterone 17-Acetate Heart Diseases Myocardial Ischemia |
Vascular Diseases Medroxyprogesterone Ischemia Arteriosclerosis Coronary Artery Disease |
Antineoplastic Agents, Hormonal Contraceptive Agents Antineoplastic Agents Contraceptives, Oral Physiological Effects of Drugs Contraceptive Agents, Female Reproductive Control Agents |
Contraceptive Agents, Male Pharmacologic Actions Pathologic Processes Therapeutic Uses Contraceptives, Oral, Synthetic Cardiovascular Diseases |