Dataset Information

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.

Conclusion

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.

SUBMITTER: Nagai Y

PROVIDER: S-EPMC4283729 | biostudies-literature | 2014 Feb

REPOSITORIES: biostudies-literature

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Publications

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).

Nagai Yoji Y Kohriyama Tatsuo T Origasa Hideki H Minematsu Kazuo K Yokota Chiaki C Uchiyama Shinichiro S Ibayashi Setsuro S Terayama Yasuo Y Takagi Makoto M Kitagawa Kazuo K Nomura Eiichi E Hosomi Naohisa N Ohtsuki Toshiho T Yamawaki Takemori T Matsubara Yoshihiro Y Nakamura Masakazu M Yamasaki Yoshimitsu Y Mori Etsuro E Fukushima Masanori M Kobayashi Shotai S Shinohara Yukito Y Yamaguchi Takenori T Matsumoto Masayasu M

International journal of stroke : official journal of the International Stroke Society 20130909 2

<h4>Background</h4>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.<h4>Methods</h4>This is a multicenter, randomized, open-label, parallel group study of patients with noncardioembolic ischemic stroke (atherothrombotic infarction, lacunar infarction, and infarction of und ...[more]

PMID: 24015915

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Project description:BackgroundAlthough statin therapy is beneficial for the prevention of initial stroke, the benefit for recurrent stroke and its subtypes remains to be determined in Asian, in whom stroke profiles are different from Caucasian. This study examined whether treatment with low-dose pravastatin prevents stroke recurrence in ischemic stroke patients.MethodsThis is a multicenter, randomized, open-label, blinded-endpoint, parallel-group study of patients who experienced non-cardioembolic ischemic stroke. All patients had a total cholesterol level between 4.65 and 6.21 mmol/L at enrollment, without the use of statins. The pravastatin group patients received 10 mg of pravastatin/day; the control group patients received no statins. The primary endpoint was the occurrence of stroke and transient ischemic attack (TIA), with the onset of each stroke subtype set to be one of the secondary endpoints.FindingAlthough 3000 patients were targeted, 1578 patients (491 female, age 66.2 years) were recruited and randomly assigned to pravastatin group or control group. During the follow-up of 4.9 ± 1.4 years, although total stroke and TIA similarly occurred in both groups (2.56 vs. 2.65%/year), onset of atherothrombotic infarction was less frequent in pravastatin group (0.21 vs. 0.64%/year, p = 0.0047, adjusted hazard ratio 0.33 [95%CI 0.15 to 0.74]). No significant intergroup difference was found for the onset of other stroke subtypes, and for the occurrence of adverse events.InterpretationAlthough whether low-dose pravastatin prevents recurrence of total stroke or TIA still needs to be examined in Asian, this study has generated a hypothesis that it may reduce occurrence of stroke due to larger artery atherosclerosis.FundingThis study was initially supported by a grant from the Ministry of Health, Labour and Welfare, Japan. After the governmental support expired, it was conducted in collaboration between Hiroshima University and the Foundation for Biomedical Research and Innovation.

Project description:There is a paucity of data on persistence of secondary prevention medications among stroke survivors in resource-limited settings where stroke is on a rapid upward trajectory and its management severely challenged. To avert new cardiovascular events after stroke, preventive medications should be promptly instituted and used continuously. We report 1-year rates and determinants of persistent utilization of secondary prevention therapies after stroke in Ghana.A retrospective observational study involving 418 stroke survivors enrolled into a Neurology clinic in a tertiary institution in central Ghana between January 2011 and December 2013. Data on demography, stroke type, risk factor profile and five secondary risk prevention medication classes namely antihypertensive, antiplatelet, statins, antidiabetic and anticoagulants were collected from patient charts. Persistence within first year after stroke was defined as continuation of all secondary preventive medications prescribed at enrollment to the Neurology clinic and it excluded 126 (?30%) patients who could not complete 12 month follow up. Data was closed for analysis in June 2015 to allow for at least 12 months of follow-up.Rates of utilization of secondary preventive medications and its intensity were influenced by stroke type and prevailing vascular risk factors. In decreasing order, antihypertensive, lipid-modifying, anti-platelet, anti-diabetic medications and anti-coagulants were prescribed at frequencies (%) of 394 (94.3%), 303 (72.5%), 274 (65.6%), 61 (14.6%) and 2 (0.5%) respectively at enrollment into the Neurology clinic (n=418). Overall, 92.1% of subjects (n=292) under follow-up for 1 year were persistent on secondary prevention medications initiated at enrollment into the neurology clinic with medication class specific rates of 97.5% for antihypertensive, 94.8% for anti-platelets, 94.1% for statins, 85.7% for anti-diabetic and 50% for anticoagulants. Abuse of alcohol was significantly associated with non-persistence, adjusted OR (95% CI) of 3.08 (1.13-8.38).Persistence of secondary preventive medications among stroke survivors in this resource-limited setting is excellent and comparable to those in resource-replete countries. There is however the need to investigate the causes of high attrition rates from care.

Dataset Information

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).

Background

Methods

Results

Conclusion

Publications

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).

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