The purpose of this project is to assist in thedesign and performance of a pilot study for a multicenter randomized clinical trial to determine whether lowering elevated serum cholesterol (C) levels after age 60, by use of one of a new class of potent cholesterol-lowering drugs, the 3-- hydroxy-3-methylglutaryl coenzyme A (HMG CoA) reductase inhibitors, will reduce mortality due to atherosclerotic cardiovascular disease. The objective of the pilot study is to determine the feasibility of conducting a long-term trial of the developed design in approximately 5600 persons. Local participation in the pilot study will consist of: Phase 1 in which investigators at the Northwest Lipid Research Clinic and the Departments of Medicine, Epidemiology, and Psychiatry and Behavioral Sciences at the University of Washington will contribute to the scientific design and implementation of the collaborative protocol; Phase 2 will involve subject recruitment and implementation of the protocol designed in Phase 1. Subjects, age 60-75 years, will be recruited from Group Health Cooperative of Puget Sound, a large local health maintenance organization. Subjects whose LDL-C is equal to or greater than 160 mg/dL will be instructed in a low-fat, low-cholesterol diet and rescreened for an elevated LDL-C value after two months of diet therapy. 500 eligible subjects will be randomized to receive either a placebo or drug in a double-blind nature. Subjects will be followed via clinic visits until either the end of Phase 2, or until the end of a full scale trial, if deemed feasible. At baseline and during 6 follow-up visits during Phase 2, subjects will have blood drawn for lipoprotein lipid and drug toxicity measurements; will be evaluated for health status, lifestyle and medication use; and will receive diet reinforcement, assessment, and drug compliance counseling. Coronary heart disease related morbidity and mortality, and all cause mortality data will be collected throughout the follow-up.
| Stoy, D B; Curtis, R C; Dameworth, K S et al. (1995) The successful recruitment of elderly black subjects in a clinical trial: the CRISP experience. Cholesterol Reduction in Seniors Program. J Natl Med Assoc 87:280-7 |
| Davis, C E; Applegate, W B; Gordon, D J et al. (1995) An empirical evaluation of the placebo run-in. Control Clin Trials 16:41-50 |
| LaRosa, J C; Applegate, W; Crouse 3rd, J R et al. (1994) Cholesterol lowering in the elderly. Results of the Cholesterol Reduction in Seniors Program (CRISP) pilot study. Arch Intern Med 154:529-39 |
