Japan Statin Treatment Against Recurrent Stroke | Clinical Trial - J-STARS


The goal of the trial was to evaluate treatment with low-dose pravastatin compared with placebo among Japanese patients with prior ischemic stroke.

Contribution to the Literature: The J-STARS trial failed to show a reduction in recurrent cerebrovascular events with low-dose pravastatin.

Study Design

Patients with prior ischemic stroke were randomized to pravastatin 10 mg (n = 793) versus control (n = 785). Study design: parallel.

Inclusion criteria:

  • Japanese patients with prior ischemic stroke 1 month to 3 years ago
  • Total cholesterol 180-240 mg/dl
  • Age >45 years, <80 years
  • Total number of enrollees: 1,578
  • Duration of follow-up: mean 4.9 years
  • Mean patient age: 66 years
  • Percentage female: 31%
  • Percentage diabetics: 23%
  • Other salient features/characteristics: Mean systolic blood pressure = 137 mm Hg

Exclusion criteria:

  • Cardioembolic stroke

Principal Findings:

The primary outcome, any cerebrovascular event, occurred in 2.56%/year in the low-dose pravastatin group versus 2.65%/year in the control group (p = NS).

Secondary outcomes:

  • Atherothrombotic infarction: 0.21%/year vs. 0.65%/year (p < 0.05), respectively
  • Any death: 0.90%/year vs. 1.11%/year, respectively
  • Hemorrhagic stroke: 0.31%/year vs. 0.31%/year, respectively


Among Japanese patients with prior ischemic stroke, low-dose pravastatin did not prevent recurrent cerebrovascular events, although it did prevent atherothrombotic infarction. The follow-up period was long; however, the dose of pravastatin that was tested may have been too low to prevent recurrent cerebrovascular events.


Presented by Dr. Masayasu Matsumoto at the International Stroke Conference (ISC), February 13, 2015, Nashville, TN.

Clinical Topics: Diabetes and Cardiometabolic Disease, Dyslipidemia, Prevention, Lipid Metabolism, Nonstatins, Novel Agents, Statins

Keywords: Stroke, Pravastatin, Cholesterol, Dyslipidemias, Infarction, Primary Prevention, Diabetes Mellitus, Hydroxymethylglutaryl-CoA Reductase Inhibitors

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