原理、设计特点及基线特征：日本心脏研究所——匹伐他汀与依折麦布在急性冠状动脉综合征中适当的血脂降低水平（HIJ-PROPER）。
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).
作者信息
Kawada-Watanabe Erisa, Ogawa Hiroshi, Koyanagi Ryo, Arashi Hiroyuki, Yamaguchi Junichi, Matsui Kunihiko, Hagiwara Nobuhisa
机构信息
Department of Cardiology, The Heart Institute of Japan, Tokyo Women's Medical University, Tokyo, Japan.
Department of Cardiology, The Heart Institute of Japan, Tokyo Women's Medical University, Tokyo, Japan.
出版信息
J Cardiol. 2017 Mar;69(3):536-541. doi: 10.1016/j.jjcc.2016.05.002. Epub 2016 Jun 24.
BACKGROUND
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 <70mg/dL, would reduce cardiovascular events more than standard statin monotherapy targeting LDL-C of <100mg/dL as per the Japan Atherosclerotic Society guideline in patients with acute coronary syndrome (ACS) and dyslipidemia.
METHODS
We 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 <70mg/dL; pitavastatin plus ezetimibe) or standard LDL-C lowering treatment (target LDL-C of 90-100mg/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.
RESULTS
Between 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.
CONCLUSION
HIJ-PROPER will determine whether targeting LDL-C of <70mg/dL with pitavastatin plus ezetimibe can improve cardiovascular outcomes in Japanese patients with ACS and dyslipidemia in comparison to targeting LDL-C of 90-100mg/dL with standard pitavastatin monotherapy.
TRIAL REGISTRATION
UMIN000002742.
背景
与西方国家目前的指南不同，对于患有动脉粥样硬化性心血管疾病和血脂异常的日本患者，即使在二级预防中，也建议适度降低低密度脂蛋白胆固醇（LDL-C）。HIJ-PROPER（日本心脏研究所-匹伐他汀和依折麦布在急性冠状动脉综合征中适当的血脂降低水平）是一项前瞻性、随机、开放标签、终点设盲的多中心试验，旨在评估对于急性冠状动脉综合征（ACS）和血脂异常患者，按照日本动脉粥样硬化协会指南，使用标准剂量他汀类药物加依折麦布将LDL-C严格控制在<70mg/dL，是否比将LDL-C控制在<100mg/dL的标准他汀类单药治疗更能减少心血管事件。
方法
我们招募了接受冠状动脉造影的ACS和血脂异常患者。参与者被随机分配至强化LDL-C降低治疗组（目标LDL-C<70mg/dL；匹伐他汀加依折麦布）或标准LDL-C降低治疗组（目标LDL-C 90 - 100mg/dL；匹伐他汀单药治疗）。主要终点是全因死亡、非致死性心肌梗死（MI）、非致死性卒中、不稳定型心绞痛以及任何缺血驱动的血运重建的复合终点。患者将至少随访3年。
结果
在2010年1月至2013年4月期间，从日本19家医院招募了1734例患者，平均年龄65.6岁；75.5%为男性，83.3%既往未使用过他汀类药物。符合条件的ACS中急性MI占61.5%。本研究预计于2016年8月报告其结果。
结论
HIJ-PROPER将确定与使用标准匹伐他汀单药治疗将LDL-C控制在90 - 100mg/dL相比，使用匹伐他汀加依折麦布将LDL-C控制在<70mg/dL是否能改善日本ACS和血脂异常患者的心血管结局。
试验注册
UMIN000002742。
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