Rationale, design features, and baseline characteristics: The Heart Institute of Japan-PRoper level of lipid lOwering with Pitavastatin and Ezetimibe in acute coRonary syndrome (HIJ-PROPER)

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• 作者：Erisa Kawada-Watanabe ; MD ; PhD^a ; Hiroshi Ogawa ; MD ; PhD ; FJCC^a ; ^{mogawa@hij.twmu.ac.jp} ; Ryo Koyanagi ; MD ; PhD^a ; Hiroyuki Arashi ; MD^a ; Junichi Yamaguchi ; MD ; PhD ; FJCC^a ; Kunihiko Matsui ; MD ; MPH ; PhD^b ; Nobuhisa Hagiwara ; MD ; PhD ; FJCC^a
• 关键词：Clinical trial ; Ezetimibe ; Pitavastatin ; Lipid-lowering ; Acute coronary syndrome
• 刊名：Journal of Cardiology
• 出版年：2017
• 出版时间：March 2017
• 年：2017
• 卷：69
• 期：3
• 页码：536-541
• 全文大小：404 K
• 卷排序：69

文摘

In contrast to current guidelines in Western countries, moderate reduction of low-density lipoprotein cholesterol (LDL-C) is recommended for Japanese patients with atherosclerotic cardiovascular disease and dyslipidemia even in secondary prevention. HIJ-PROPER (Heart Institute of Japan-PRoper level of lipid lOwering with Pitavastatin and Ezetimibe in acute coRonary syndrome) is a prospective, randomized, open-label, blinded endpoint multicenter trial designed to assess whether closely controlled LDL-C lowering with a standard statin dose plus ezetimibe, targeting LDL-C of <70 mg/dL, would reduce cardiovascular events more than standard statin monotherapy targeting LDL-C of <100 mg/dL as per the Japan Atherosclerotic Society guideline in patients with acute coronary syndrome (ACS) and dyslipidemia.MethodsWe recruited patients with ACS and dyslipidemia who had undergone coronary angiography. Participants are randomly allocated to either intensive LDL-C lowering treatment (target LDL-C of <70 mg/dL; pitavastatin plus ezetimibe) or standard LDL-C lowering treatment (target LDL-C of 90–100 mg/dL; pitavastatin monotherapy). The primary endpoint is a composite of total death, non-fatal myocardial infarction (MI), non-fatal stroke, unstable angina, and any ischemia-driven revascularization. Patients will be followed for a minimum of 3 years.ResultsBetween January 2010 and April 2013, 1734 patients were enrolled from 19 hospitals in Japan with a mean age of 65.6 years; 75.5% were men and 83.3% were statin-naïve. The qualifying ACS was an acute MI in 61.5%. This study is expected to report its findings in August 2016.ConclusionHIJ-PROPER will determine whether targeting LDL-C of <70 mg/dL with pitavastatin plus ezetimibe can improve cardiovascular outcomes in Japanese patients with ACS and dyslipidemia in comparison to targeting LDL-C of 90–100 mg/dL with standard pitavastatin monotherapy.Trial registrationUMIN000002742.