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

BackgroundAlthough 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.MethodsThis 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.ResultsA 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.ConclusionThis 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.

The Japan Statin Treatment Against Recurrent Stroke (J-STARS): A Multicenter, Randomized, Open-label, Parallel-group Study

“…As previously reported ( Nagai et al, 2014 ), although the sample size was initially set to be 3000, the target number was not achieved and 1589 patients were recruited for this study ( Fig. 1 ), largely due to the narrower window of patient recruitment.…”

“…The design and baseline data of this prospective randomized, open-labeled, blinded-endpoint (PROBE) study was reported previously ( Nagai et al, 2014 ). Briefly, patients aged 45 to 80 years with a history of non-cardioembolic ischemic stroke within the preceding one month to three years were enrolled from 123 centers, between March 2004 and February 2009.…”

“…When patient underwent recurrent stroke or other vascular events, such event information was sent to the data center, and managed by dedicated data managers. Brain MRI or CT imaging was performed as previously described ( Nagai et al, 2014 ), so was the measurement of total cholesterol, low density lipoprotein (LDL) cholesterol, triglyceride, and high density lipoprotein (HDL) cholesterol. Treatment compliance was monitored at every clinical visit.…”

“…The committees were annually held during the study period, in which each event was carefully reviewed based on reports submitted from the participating centers, in a manner strictly blinded from the allocated group information. Also, each event was evaluated in accordance with the predefined definition, the details of which were previously reported ( Nagai et al, 2014 ). For the adjudication of events, the final decision was made by consensus of all committee members.…”

Different Influences of Statin Treatment in Preventing At-Risk Stroke Subtypes: A Post Hoc Analysis of J-STARS

“…Details of the rationale, study design, characteristics of the participants, and principal results in J-STARS have been published elsewhere [6][7][8] . This study was conducted as a post hoc analysis of J-STARS under the health insurance system of Japan and in accordance with the Declaration of Helsinki and Ethical Guidelines on Clinical Studies of the Ministry of Health, Labour and Welfare of Japan.…”