This contract is a part of a multicenter pilot study on peripheral arterial disease. The purpose of this clinical trial is to assess the feasibility of a multifactorial therapeutic approach in patients with peripheral arterial disease. The full-scale trial, if performed, is intended to assess the effect of these interventions in reducing cardiovascular mortality in patients with peripheral arterial disease. The primary objectives of the study are to: 1) determine the exact type and dosage of drug combination which would result in an increase in HDL- C level in the treatment group and equivalent reduction in LDL-C level in the treatment group and equivalent reductions in LDL-C level in the treatment and comparison groups: 2) determine if antioxidants in clinically appropriate doses alter plasma lipid peroxidase and oxidized LDL levels in patients with PAD; 3) determine the drug interactions and adverse effects of these various interventions; in particular, the effects of lipid-modifying and antioxidant drugs on coagulation parameters in patients on warfarin; 4) determine the feasibility of identifying, recruiting and following patients with PAD from a variety of medical clinics (i.e., stop smoking clinics, diabetic clinics, peripheral vascular clinics). The study population shall consist of 600 patients with PAD or approximately 100 participants in each of six Clinical Centers.
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| Pettinger, M B; Waclawiw, M A; Davis, K B et al. (1999) Compliance to multiple interventions in a high risk population. Ann Epidemiol 9:408-18 |
