National Institutes of Health, National Heart, Lung, and Blood Institute, Contracts Operations Branch, 6701 Rockledge Drive, Room 6100, MSC 7902, Bethesda, MD 20892

A -- STUDY OF CORONARY REVASCULARIZATION AND THERAPEUTICS EVALUATIONS (SOCRATES) SOL RFP NHLBI-HV-98-32 DUE 012199 POC William M. Stevens, Contracting Officer; (301) 435-0345, fax (301) 480-3430. WEB: http://www4.od.nih.gov/ocm/contracts/rfps/mainpage.htm, http://www4.od.nih.gov/ocm/contracts/rfps/mainpage.htm. E-MAIL: ws69s@nih.gov, ws69s@nih.gov. The National Heart, Lung, and Blood Institute has a requirement for 10 Clinical Network Center's (CNC) to conduct a multicenter randomized clinical trial, enrolling and following a total of 6,000 patients for a minimum of 4 years. The "SOCRATES" trial will assess the benefits and risks comparing three clinically employed strategies (two medical anti-ischemic strategies and early revascularization) with respect to long term morbidity and mortality. The trial results will provide a rational basis for safe and effective therapy for these types of patients with stable CHD, and will provide insights into the role of ischemia in the long-term clinical outcome of CHD patients. Furthermore, the results will be evaluated for significant health care cost implications. The study will enroll a total of 6,000 patients with stable coronary disease (CHD) (based on eligibility and exclusion criteria) in whom there is equipoise between medical therapy and revascularization (catheter-based or surgical). The choice between the potential revascularization approach that might be used, PTCA or CABG, will be made by physician and patient before randomization. The protocol, including study design, entry criteria, randomization procedures, and treatment strategies are provided in the RFP. Final drug regimens for medical strategies and analyses which will be incorporated into the protocol will be defined collaboratively during the implementation phase developed by a planning committee that will include the successful respondent to this RFP. The trial will address two key questions of therapeutic strategy in the management of coronary heart disease (CHD): first, in medical management, does anti-ischemic therapy escalated to a maximum tolerated regimen, targeted to alleviate all of the ischemia, confer long-term morbidity and mortality benefits beyond anti-ischemic therapy targeted just for relief of angina; and second, have advances in medical management of CHD (particularly aggressive lipid management, anti-thrombotic therapy, andlife style risk factor modification) changed the threshold at which mechanical revascularization is warranted? These questions will be addressed in patients with stable CHD and objective evidence of ischemia who are eligible for catheter-based revascularization (such as PTCA) or surgical revascularization with coronary artery bypass surgery (CABG). Functional status and health care costs related to the above strategies will also be assessed. Each CNC will consist of a network of collaborating clinical units, which may consist of medical sites and/or individual clinicians that will be involved in the evaluation, enrollment and treatment of patients in the trial. Each CNC will be responsible for timely recruitment and clinical care quality assurances according to the protocol, and providing the network's scientific leadership and administrative tasks. Each CNC will be responsible for recruitment of minimum 600 patients, including recruitment of women and specific minorities (African Americans, Hispanic, Native American, Asian). The CNC will have the primary responsibility for timely evaluation and correction of recruitment problems, including development and implementation of alternative strategies to achieve the stipulated goal, and funding the related activities. It is anticipated that the leading center of the CNC will conduct at least yearly site visits within the network to supervise recruitment activities and assure high quality performance. The CNC activities will be coordinated with the Clinical Data Coordinating Center (CDCC), and may include site visits conducted by the CDCC along with other organizational components of the study leading to certification of new sites, termination of recruitment at existing site, and appropriate follow-up of patients enrolled from the terminated site. Each CNC will closely collaborate with and assist the CDCC in implementation and standardization of the protocol within their network. Each CNC will have a communication network, including Internet capability. The data willbe transferred directly, in timely fashion, from the individual recruitment sites to the CDCC and other relevant central units, unless arranged otherwise. The fixed fee and cost-reimbursement contracts will be awarded for seven years. This is not the Request for Proposals (RFP). RFP No. NHLBI-HV-98-32 will be released on or about November 13, 1998 on the NHLBI contracts web page at http://www.nhlbi.nih.gov/nhlbi/rafs/rfas.htm#rfp. There are no paper copies. Interested organizations should review and download the streamlined RFP designated as RFP # NHLBI-HV-98-32 which will appear under the list of RFPs for the National Heart, Lung, and Blood Institute. Further instructions and forms for proposal submission are located at the menu selection entitled "Streamlined RFP References" which is located at the web page for the NIH Request For Proposals Directory, URL:http://www4.od.nih.gov/ocm/contracts/rfps/mainpage.htm. This proposed program is not set aside for small business vendors; the SIC Code is 8731. Posted 10/26/98 (W-SN265316). (0299)

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