TRIAL OF LOVASTATIN AND ASPIRIN IN ATHEROSCLEROSIS

这种协作性双盲安慰剂的主要目的是- 对照试验是使用析因设计来确定是否 阿司匹林(每天324毫克)或洛伐他汀(每天20-40毫克)，超过平均水平 三年的疗程，延缓了疾病的进展 高危颈动脉粥样硬化斑块 无症状颈动脉狭窄的个体。男人和女人 无临床明显的心脑血管疾病 年龄在50岁或以上，有血清总胆固醇 在大约50毫克(220毫克/分升)到90毫克(260毫克/分升)之间 Mg/dl)百分位数和至少一个具有厚度的斑块 在1.0到4.0毫米之间有资格参加。一个 次要目标是确定长期服用的安全性 采用两种积极干预措施进行治疗，分别是单独干预和联合干预 组合。冠状动脉和脑血管事件将是 进行监测和自然历史研究。 动脉粥样硬化病变的进展将被确定。 每半年一次。从远壁计算的平均壁厚 颈动脉(总动脉、分叉动脉和内动脉)将是 主要结果衡量标准。最大壁厚/最小壁厚 还将确定管腔直径以及全局范围 得分。降脂治疗的目标是使总的 血清胆固醇低于180 mg/dl。 试验的有利结果将对公众健康产生重大影响 对动脉粥样硬化及其预防/控制的启示 并发症。B型超声成像的成功应用 将极大地影响医疗保健(监测斑块的能力 在个体中进行非侵入性进展)并允许减少 在未来的临床试验中评估治疗的成本和时间 动脉硬化。

The primary objective of this collaborative double-blind placebo- controlled trial is to determine, using a factorial design, whether aspirin (324 mg/day) or lovastatin (20-40 mg/day), over an average treatment period of three years, retards the progression of atherosclerotic plaques in the carotid arteries of high risk individuals with asymptomatic carotid stenosis. Men and women free of clinically evident coronary and cerebrovascualr disease who are 50 years of age or older, with total serum cholesterol levels between approximately the 50th (220 mg/dl) and 90th (260 mg/dl) percentiles and at least one plaque with a thickness between 1.0 and 4.0 mm are eligible for participation. A secondary objective is to determine the safety of long-term therapy with the two active interventions, individually and in combination. Coronary and cerebrovascular events will be monitored and natural history studies conducted. Progression of the atherosclerotic lesions will be determined semi-annually. Mean wall thickness from the far wall of the carotid artery (common, bifurcation and internal) will be the primary outcome measure. Maximum wall thickness/minimum lumen diameter will also be determined as well as a global extent score. The goal of the lipid-lowering treatment is to bring total serum cholesterol below 180 mg/dl. A favorable outcome of the trial will have major public health implications for the prevention/control of atherosclerosis and its complications. The successful employment of B-mode imaging will greatly impact on health care (ability to monitor plaque progression non-invasively in individuals) and permit a reduction in cost and time for future clinical trials evaluating treatment for atherosclerosis.