title: The Japan Statin Treatment Against Recurrent Stroke (J-STARS) Echo Study: Rationale and Trial Protocol.
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.
  
  
  METHODS
  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.
  
  
  CONCLUSIONS
  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.
authors.affiliation: Department of Cerebrovascular Medicine, National Cerebral and Cardiovascular Center, Suita, Osaka, Japan.
authors.forename: Kazunori
authors.initials: K
authors.lastname: Toyoda
authors.affiliation: Department of Cerebrovascular Medicine, National Cerebral and Cardiovascular Center, Suita, Osaka, Japan. Electronic address: kminemat@ncvc.go.jp.
authors.forename: Kazuo
authors.initials: K
authors.lastname: Minematsu
authors.affiliation: Department of Cerebrovascular Medicine and Neurology, National Hospital Organization Kyushu Medical Center, Fukuoka, Japan.
authors.forename: Masahiro
authors.initials: M
authors.lastname: Yasaka
authors.affiliation: Center for Clinical Research, Kobe University Hospital, Kobe, Japan.
authors.forename: Yoji
authors.initials: Y
authors.lastname: Nagai
authors.affiliation: Department of Clinical Neuroscience and Therapeutics, Hiroshima University Graduate School of Biomedical and Health Sciences, Hiroshima, Japan.
authors.forename: Naohisa
authors.initials: N
authors.lastname: Hosomi
authors.affiliation: Division of Biostatistics and Clinical Epidemiology, University of Toyama Graduate School of Medicine and Pharmaceutical Sciences, Toyama, Japan.
authors.forename: Hideki
authors.initials: H
authors.lastname: Origasa
authors.affiliation: Department of Neurology, Tokyo Women's Medical University, Tokyo, Japan.
authors.forename: Kazuo
authors.initials: K
authors.lastname: Kitagawa
authors.affiliation: Clinical Research Center, International University of Health and Welfare, Center for Brain and Cerebral Vessels, Sanno Hospital and Sanno Medical Center, Tokyo, Japan.
authors.forename: Shinichiro
authors.initials: S
authors.lastname: Uchiyama
authors.affiliation: Department of Cerebrovascular Medicine, National Cerebral and Cardiovascular Center, Suita, Osaka, Japan.
authors.forename: Masatoshi
authors.initials: M
authors.lastname: Koga
authors.affiliation: Department of Clinical Neuroscience and Therapeutics, Hiroshima University Graduate School of Biomedical and Health Sciences, Hiroshima, Japan.
authors.forename: Masayasu
authors.initials: M
authors.lastname: Matsumoto
mesh_terms: D000368:Aged; D000369:Aged, 80 and over; D000924:Anticholesteremic Agents / Q000627:therapeutic use*; D002339:Carotid Arteries / Q000000981:diagnostic imaging / Q000187:drug effects; D059168:Carotid Intima-Media Thickness; D002985:Clinical Protocols; D005260:Female; D005500:Follow-Up Studies; D006801:Humans; D006949:Hyperlipidemias / Q000188:drug therapy; D007564:Japan / Q000453:epidemiology; D008297:Male; D008875:Middle Aged; D017063:Outcome Assessment, Health Care; D017035:Pravastatin / Q000627:therapeutic use*; D012008:Recurrence; D018709:Statistics, Nonparametric; D020521:Stroke / Q000000981:diagnostic imaging / Q000517:prevention & control*; D014463:Ultrasonography
chemical_list: D000924:Anticholesteremic Agents; D017035:Pravastatin
keywords: Carotid artery; dyslipidemia; intima-media thickness; statin; stroke prevention; ultrasound