title: Rationale, design, and baseline features of a randomized controlled trial to assess the effects of statin for the secondary prevention of stroke: the Japan Statin Treatment Against Recurrent Stroke (J-STARS).
abstract: BACKGROUND
  Although statin therapy is beneficial for preventing first strokes, the benefit for recurrent stroke and its sub-types remains unknown in Asian populations. The aim of this study is to examine the role of pravastatin in the secondary prevention of stroke in Japanese patients.
  
  
  METHODS
  This is a multicenter, randomized, open-label, parallel group study of patients with noncardioembolic ischemic stroke (atherothrombotic infarction, lacunar infarction, and infarction of undetermined etiology). All patients were diagnosed with hyperlipidemia and with a total cholesterol level between 180 and 240 mg/dl at enrollment. Patients in the treatment group receive 10 mg/day of pravastatin, and those in the control group receive no statin treatment. The primary end-point is the recurrence of stroke, including transient ischemic attack. The secondary end-points include the onset of respective stroke sub-types and functional outcomes related to stroke. The patients were enrolled for five-years and will be followed up for five-years.
  
  
  RESULTS
  A total of 1578 eligible patients (age: 66·2 years, men: 68·8%), including 64·2% with lacunar infarction, 25·4% with atherothrombotic infarction, and 10·4% with infarction of undetermined etiology were included in this study. Lipid levels were generally well controlled (total cholesterol: 210·0 mg/dl, low density lipoprotein cholesterol: 129·5 mg/dl) at baseline. In addition, the disability of patients was relatively mild, and cognitive function was preserved in the majority of patients.
  
  
  CONCLUSIONS
  This article reports the rationale, design, and baseline features of a randomized controlled trial to assess the effects of statin for the secondary prevention of stroke. Follow-ups of patients are in progress and will end in 2014.
authors.affiliation: Foundation for Biomedical Research and Innovation Translational Research Informatics Center, Kobe, Japan.
authors.forename: Yoji
authors.initials: Y
authors.lastname: Nagai
authors.forename: Tatsuo
authors.initials: T
authors.lastname: Kohriyama
authors.forename: Hideki
authors.initials: H
authors.lastname: Origasa
authors.forename: Kazuo
authors.initials: K
authors.lastname: Minematsu
authors.forename: Chiaki
authors.initials: C
authors.lastname: Yokota
authors.forename: Shinichiro
authors.initials: S
authors.lastname: Uchiyama
authors.forename: Setsuro
authors.initials: S
authors.lastname: Ibayashi
authors.forename: Yasuo
authors.initials: Y
authors.lastname: Terayama
authors.forename: Makoto
authors.initials: M
authors.lastname: Takagi
authors.forename: Kazuo
authors.initials: K
authors.lastname: Kitagawa
authors.forename: Eiichi
authors.initials: E
authors.lastname: Nomura
authors.forename: Naohisa
authors.initials: N
authors.lastname: Hosomi
authors.forename: Toshiho
authors.initials: T
authors.lastname: Ohtsuki
authors.forename: Takemori
authors.initials: T
authors.lastname: Yamawaki
authors.forename: Yoshihiro
authors.initials: Y
authors.lastname: Matsubara
authors.forename: Masakazu
authors.initials: M
authors.lastname: Nakamura
authors.forename: Yoshimitsu
authors.initials: Y
authors.lastname: Yamasaki
authors.forename: Etsuro
authors.initials: E
authors.lastname: Mori
authors.forename: Masanori
authors.initials: M
authors.lastname: Fukushima
authors.forename: Shotai
authors.initials: S
authors.lastname: Kobayashi
authors.forename: Yukito
authors.initials: Y
authors.lastname: Shinohara
authors.forename: Takenori
authors.initials: T
authors.lastname: Yamaguchi
authors.forename: Masayasu
authors.initials: M
authors.lastname: Matsumoto
mesh_terms: D000328:Adult; D000368:Aged; D000369:Aged, 80 and over; D000924:Anticholesteremic Agents / Q000627:therapeutic use*; D004791:Enzyme Inhibitors / Q000627:therapeutic use*; D005260:Female; D006801:Humans; D007564:Japan / Q000453:epidemiology; D008137:Longitudinal Studies; D008297:Male; D008875:Middle Aged; D010045:Outpatients; D017035:Pravastatin / Q000627:therapeutic use*; D055502:Secondary Prevention; D012720:Severity of Illness Index; D018709:Statistics, Nonparametric; D020521:Stroke / Q000517:prevention & control*; D016896:Treatment Outcome
chemical_list: D000924:Anticholesteremic Agents; D004791:Enzyme Inhibitors; D017035:Pravastatin
keywords: recurrence; secondary prevention; statins; stroke
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