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EFFECTS ON INTIMA MEDIA THICKNESS: ROSUVASTATIN 40 MG (METEOR)

EFFECTS ON INTIMA MEDIA THICKNESS: ROSUVASTATIN 40 MG (METEOR)
对内膜中层厚度的影响:瑞舒伐他汀 40 MG (METEOR)
批准号:
7376675
负责人:
JOHN R CROUSE
金额:
$4.64万
依托单位国家:
美国
项目类别:
财政年份:
2006
资助国家:
美国
项目状态:
已结题
起止时间:
2006-04-17 至 2007-02-28

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中文摘要
翻译
该子项目是利用NIH/NCRR资助的中心赠款提供的资源的许多研究子项目之一。子项目和研究者(PI)可能从另一个NIH来源获得了主要资金,因此可以在其他CRISP条目中表示。所列机构为中心机构,不一定为研究者机构。本研究旨在评价瑞舒伐他汀与安慰剂相比对心血管事件低风险的无症状受试者颈动脉内膜中层厚度(IMT)的影响。受试者的LDL-胆固醇将在130至189 mg/dl之间。本研究将评估接受瑞舒伐他汀40 mg与安慰剂治疗2年的受试者的IMT变化是否随时间存在差异。如果发现显著差异,则将检查瑞舒伐他汀受试者,以确定治疗期间IMT是否显著消退。中心实验室将进行所有血脂测量。中心实验室还将进行安全性实验室检查(生化检查和妊娠试验)。安全性测量包括临床评价、患者监测和实验室评估。将通过片剂计数监测依从性。参与者可以接受降低胆固醇的药物治疗,并可以从参与本研究中获得胆固醇降低和/或直接健康益处。
英文摘要
This subproject is one of many research subprojects utilizing the resources provided by a Center grant funded by NIH/NCRR. The subproject and investigator (PI) may have received primary funding from another NIH source, and thus could be represented in other CRISP entries. The institution listed is for the Center, which is not necessarily the institution for the investigator. This research study is designed to evaluate the effect of rosuvastatin versus placebo on carotid intima media thickness (IMT) in asymptomatic participants who are at low risk for cardiovascular events. Participants will have an LDL-cholesterol between 130 and 189 mg/dl. The study will assess whether there is a difference over time in the IMT change in participants who are treated for 2 years with rosuvastatin 40 mg versus placebo. If a significant difference is found, then the rosuvastatin subjects will be examined to determine whether there is significant regression in IMT during the treatment period. A central laboratory will perform all lipid measurements. The central laboratory will also perform safety labs (chemistry panels and pregnancy tests). Safety measurements are clinical evaluation, patient monitoring, and laboratory assessment. Compliance will be monitored by tablet count. Participants may receive cholesterol-lowering medication and may receive a reduction in cholesterol and/or direct health benefits from participation in this s
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