PERIPHERAL ARTERIAL DISEASE

该合同是外围设备多中心试点研究的一部分 动脉疾病。这项临床试验的目的是评估 多因素治疗方法在慢性前列腺癌患者中的可行性 外周动脉疾病。如果进行全面试验， 旨在评估这些干预措施在减少 外周动脉疾病患者的心血管死亡率。 研究的主要目标是：1)确定确切的类型 和剂量的药物组合，这将导致增加 治疗组高密度脂蛋白胆固醇水平及相应的低密度脂蛋白胆固醇降低 治疗组和对照组的水平：2)确定是否 临床适当剂量的抗氧化剂改变血脂 PAD患者的过氧化物酶和氧化低密度脂蛋白水平；3)测定 这些不同干预措施的药物相互作用和不良反应 尤其是调脂和抗氧化药物对血管紧张素转换酶的影响 华法林患者的凝血参数；4)测定 识别、招募和跟踪PAD患者的可行性 来自各种医疗诊所(例如，戒烟诊所、糖尿病 诊所、外周血管诊所)。研究人群应 由600名PAD患者或大约100名参与者组成 六个临床中心中的每个。此合同操作是针对 协调中心的努力。

This Contract is a part of a multicenter pilot study of 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 the HDL-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. This contract action is for the Coordinating Center effort.