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日本他汀类药物预防复发性卒中治疗(J-STARS)超声心动图研究:原理与试验方案

The Japan Statin Treatment Against Recurrent Stroke (J-STARS) Echo Study: Rationale and Trial Protocol.

作者信息

Toyoda Kazunori, Minematsu Kazuo, Yasaka Masahiro, Nagai Yoji, Hosomi Naohisa, Origasa Hideki, Kitagawa Kazuo, Uchiyama Shinichiro, Koga Masatoshi, Matsumoto Masayasu

机构信息

Department of Cerebrovascular Medicine, National Cerebral and Cardiovascular Center, Suita, Osaka, Japan.

Department of Cerebrovascular Medicine, National Cerebral and Cardiovascular Center, Suita, Osaka, Japan.

出版信息

J Stroke Cerebrovasc Dis. 2017 Mar;26(3):595-599. doi: 10.1016/j.jstrokecerebrovasdis.2016.11.113. Epub 2016 Dec 20.

DOI:10.1016/j.jstrokecerebrovasdis.2016.11.113
PMID:28010953
Abstract

OBJECTIVE

The preventive effect of 3-hydroxy-3-methylglutaryl-coenzyme A reductase inhibitors (statins) on progression of carotid intima-media complex thickness (IMT) has been shown exclusively in nonstroke Western patients. The Japan Statin Treatment Against Recurrent Stroke (J-STARS) Echo Study aims to determine the effect of pravastatin on carotid IMT in Japanese patients with hyperlipidemia who developed noncardioembolic ischemic stroke.

DESIGN

This is a substudy of the J-STARS, a multicenter, randomized, open-label, blinded-end point, parallel-group trial to examine whether pravastatin reduces stroke recurrence in patients with noncardioembolic stroke. The patients are randomized to receive pravastatin (10 mg daily) or not to receive any statins. Carotid ultrasonography is performed by well-trained certified examiners in each participating institute, and the recorded data are measured centrally. The primary outcome is change in the IMT of the distal wall in a consecutive 2-cm section on the central side of the common carotid artery bifurcation over 5 years of observation.

CONCLUSION

The trial may help determine if the usual dose of pravastatin for daily clinical practice in Japan can affect carotid IMT in Japanese patients with noncardioembolic stroke.

摘要

目的

3-羟基-3-甲基戊二酰辅酶A还原酶抑制剂(他汀类药物)对颈动脉内膜中层复合体厚度(IMT)进展的预防作用仅在非卒中的西方患者中得到证实。日本他汀类药物预防复发性卒中研究(J-STARS)回声研究旨在确定普伐他汀对患有非心源性缺血性卒中的日本高脂血症患者颈动脉IMT的影响。

设计

这是J-STARS的一项子研究,J-STARS是一项多中心、随机、开放标签、盲终点、平行组试验,旨在研究普伐他汀是否能降低非心源性卒中患者的卒中复发率。患者被随机分为接受普伐他汀(每日10毫克)或不接受任何他汀类药物治疗。由各参与机构训练有素的认证检查人员进行颈动脉超声检查,并对记录的数据进行集中测量。主要结局是在5年观察期内,颈总动脉分叉中心侧连续2厘米节段远端壁IMT的变化。

结论

该试验可能有助于确定日本日常临床实践中普伐他汀的常用剂量是否会影响患有非心源性卒中的日本患者的颈动脉IMT。

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