CLINICAL COORDINATING CENTER FOR THE ANGIOGRAPHIC TRIAL IN WOMEN NIH GUIDE, Volume 23, Number 16, April 29, 1994 RFP AVAILABLE: NHLBI-HV-94-16 P.T. 34 Keywords: Clinical Trial Data Management/Analysis+ Cardiovascular Diseases National Heart, Lung, and Blood Institute The Lipid Metabolism-Atherogenesis Branch, Division of Heart and Vascular Diseases, National Heart, Lung, and Blood Institute (NHLBI) has a requirement for the establishment of a clinical coordinating center to access whether hormonal replacement therapy and/or antioxidant treatment will stabilize or inhibit progression and induce regression of coronary plaques in women. In addition, the mechanisms by which these treatments may modify atherosclerosis in women will be explored. Angiographic changes will be primary endpoints of this trial. Other endpoints, such as carotid and intracoronary ultrasound, magnetic resonance coronary angiography, assessment of endothelial function, may be proposed and will be considered during protocol development. Quantitative computerized analysis of the angiograms will be performed by a central laboratory. In addition, it is proposed to follow lipid and clotting parameters that will be analyzed by a central laboratory facility. The study population will consist of 450 postmenopausal women with angiographically documented CAD defined as at least 30 percent but no more than 75 percent occlusion of any single coronary artery. In order to assure that the study will provide meaningful data on diverse racial/ethnic groups, the overall goal will be to recruit 50 percent minority women. The following will be exclusion criteria: (1) age over 75; (2) any condition that would compromise participation in the study or the likelihood of obtaining exit angiograms, such as a life-threatening disease or a chronic illness likely to require frequent hospitalizations and/or treatment adjustments that may affect outcome variables; (3) contraindications to the use of any of the study interventions; and (4) clear need for treatment with any of the interventions for this trial. It is estimated that 50 percent of eligible women requiring angiographic evaluation will agree to participate in the study, and 50 percent of these women will meet the angiographic criteria. The study will have a 2x2 factorial design and roughly equal numbers of eligible women will be randomized into four treatment groups: (1) both active therapies (hormone replacement and antioxidant), (2) active hormone replacement therapy and antioxidant placebo, (3) active antioxidant therapy and hormone replacement placebo, and (4) double placebo plus usual care. It is expected that hormone replacement therapy will consist of estrogen plus a progestin for most or all gynecologically intact women, and unopposed estrogen for women with hysterectomies. With regards to antioxidants, most likely a combination of vitamin E, beta-carotene, and vitamin C will be used. Allowing for 20 percent attrition over three years of follow-up, it is anticipated that at least 360 women will be analyzed at the end of the study. One award is anticipated. This incrementally funded contract will be awarded for five years. This is not a Request for Proposals (RFP). RFP No. NHLBI-HV-94-16 will be released on or about April 28, 1994. INQUIRIES RFP No. NIH-NHLBI-HV-94-16 will be released on or about April 28, 1994. Written requests must include three self-addressed labels and must site RFP No. NIH-NHLBI-HV-94-16. To insure timely receipt of requests for RFP No. NHLBI-HV-94-16, facsimile requests will be accepted. Requests for copies of the RFP are to be sent to: Shari L. Spencer Contracts Operations Branch National Heart, Lung, and Blood Institute Federal Building, Room 4C04 Bethesda, MD 20892 Telephone: (301) 496-6838 FAX: (301) 496-9501 .
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