TRIAL OF LOVASTATIN AND ASPIRIN IN ATHEROSCLEROSIS

洛伐他汀和阿司匹林治疗动脉粥样硬化的试验

• 批准号: 3354289
• 负责人: CURT D FURBERG
• 金额: $ 90.13万
• 依托单位: WAKE FOREST UNIVERSITY
• 依托单位国家: 美国
• 财政年份: 1988
• 资助国家: 美国
• 起止时间: 1988-05-01 至 1993-04-30
• 项目状态: 已结题
• 来源: https://reporter.nih.gov/project-details/3354289
• 关键词: antiatherogenic agent; antihyperlipoproteinemic agent; atherosclerosis; atherosclerotic plaque; cardiovascular disorder chemotherapy; cardiovascular disorder prevention; cholesterol; clinical trials; combination chemotherapy; coronary disorder; disease /disorder proneness /risk; human subject; human therapy evaluation; longitudinal human study; warfarin

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.

这个合作的双盲安慰剂的主要目的是- 对照试验是使用析因设计确定， 阿司匹林（324 mg/天）或洛伐他汀（20-40 mg/天），超过平均 三年的治疗期，延缓了 高危颈动脉粥样硬化斑块 无症状颈动脉狭窄的个体。 男女 无临床上明显的冠状动脉和血管疾病 50岁或以上，血清总胆固醇 水平在大约第50（220 mg/dl）和第90（260 mg/dl）之间 mg/dl）的血小板和至少一个厚度为 在1.0和4.0 mm之间的有资格参与。 一 次要目的是确定长期 治疗与两个积极的干预措施，单独和 组合. 冠状动脉和脑血管事件将 进行监测和自然历史研究。 将确定动脉粥样硬化病变的进展 半年一次 从远端壁的平均壁厚 颈动脉（总动脉、分叉动脉和颈内动脉）将是 主要结果测量。 最大壁厚/最小 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 预防/控制动脉粥样硬化及其 并发症 B型成像的成功应用 将对医疗保健产生巨大影响（监测斑块的能力 在个体中非侵入性地进展），并允许减少 未来临床试验的成本和时间， 动脉粥样硬化