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一项使用血管内超声评估瑞舒伐他汀对日本受试者冠状动脉粥样硬化影响的研究的原理与设计:COSMOS研究(在日本受试者中使用血管内超声测量瑞舒伐他汀对冠状动脉粥样硬化影响的研究)

Rationale and design for a study using intravascular ultrasound to evaluate effects of rosuvastatin on coronary artery atheroma in Japanese subjects: COSMOS study (Coronary Atherosclerosis Study Measuring Effects of Rosuvastatin Using Intravascular Ultrasound in Japanese Subjects).

作者信息

Takayama Tadateru, Hiro Takafumi, Yamagishi Masakazu, Daida Hiroyuki, Saito Satoshi, Yamaguchi Tetsu, Matsuzaki Masunori

机构信息

Division of Cardiovascular Medicine, Department of Medicine, Nihon University School of Medicine, Tokyo, Japan.

出版信息

Circ J. 2007 Feb;71(2):271-5. doi: 10.1253/circj.71.271.

Abstract

BACKGROUND

There have been few multicenter studies using intravascular ultrasound (IVUS) to assess the process of atherosclerosis in a Japanese population with hypercholesterolemia that is being treated with 3-hydroxy-3-methylglutaryl coenzyme A reductase inhibitors for control of low-density lipoprotein-cholesterol.

METHODS AND RESULTS

An open-label multicenter study is planned to evaluate with IVUS whether treatment with rosuvastatin for 76 weeks results in regression of coronary artery atheroma volume in patients who have coronary heart disease (CHD) and hypercholesterolemia. Sample size is 200 subjects with CHD who are to undergo percutaneous coronary intervention. The planned duration is between October 2005 and October 2008.

CONCLUSIONS

The COSMOS study will be the first multicenter cardiovascular study in a Japanese population and may provide new evidence on the effects of rosuvastatin on the progression of coronary atherosclerotic lesions.

摘要

背景

很少有使用血管内超声(IVUS)来评估接受3-羟基-3-甲基戊二酰辅酶A还原酶抑制剂治疗以控制低密度脂蛋白胆固醇的日本高胆固醇血症患者动脉粥样硬化进程的多中心研究。

方法与结果

一项开放标签多中心研究计划使用IVUS评估瑞舒伐他汀治疗76周是否能使患有冠心病(CHD)和高胆固醇血症的患者冠状动脉粥样斑块体积缩小。样本量为200名将接受经皮冠状动脉介入治疗的CHD患者。计划持续时间为2005年10月至2008年10月。

结论

COSMOS研究将是日本人群中的首个多中心心血管研究,可能会为瑞舒伐他汀对冠状动脉粥样硬化病变进展的影响提供新证据。

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