PERIPHERAL ARTERIAL DISEASE

这份合同是外周动脉多中心先导研究的一部分 疾病。本次临床试验的目的是评估其可行性。 外周血肿患者多因素治疗的研究进展 动脉疾病。如果进行全面试验，其目的是 评估这些干预措施在减少心血管疾病方面的效果 外周动脉疾病患者的死亡率。初级阶段 研究的目标是：1)确定确切的类型和剂量 药物组合会导致高密度脂蛋白-C水平升高 治疗组与治疗中等量降低低密度脂蛋白水平 在治疗和治疗中降低低密度脂蛋白水平和同等水平 对照组；2)确定抗氧化剂在临床上是否合适 剂量改变患者血浆脂质过氧化物酶和氧化低密度脂蛋白水平 使用PAD；3)确定这些药物的相互作用和副作用 各种干预措施；特别是调脂和调脂的效果 抗氧化剂对华法林患者凝血指标的影响 确定识别、招募和跟踪患者的可行性 使用来自各种医疗诊所的PAD(即，戒烟诊所， 糖尿病诊所、外周血管诊所)。研究人群应 包括600名PAD患者或每名患者约100名参与者 六个临床中心。

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.