title: 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).
abstract: 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.
  
  
  
  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.
  
  
  
  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.
  
  
  
  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.
  
  
  
  UMIN000002742.
authors.affiliation: Department of Cardiology, The Heart Institute of Japan, Tokyo Women's Medical University, Tokyo, Japan.
authors.forename: Erisa
authors.initials: E
authors.lastname: Kawada-Watanabe
authors.affiliation: Department of Cardiology, The Heart Institute of Japan, Tokyo Women's Medical University, Tokyo, Japan. Electronic address: mogawa@hij.twmu.ac.jp.
authors.forename: Hiroshi
authors.initials: H
authors.lastname: Ogawa
authors.affiliation: Department of Cardiology, The Heart Institute of Japan, Tokyo Women's Medical University, Tokyo, Japan.
authors.forename: Ryo
authors.initials: R
authors.lastname: Koyanagi
authors.affiliation: Department of Cardiology, The Heart Institute of Japan, Tokyo Women's Medical University, Tokyo, Japan.
authors.forename: Hiroyuki
authors.initials: H
authors.lastname: Arashi
authors.affiliation: Department of Cardiology, The Heart Institute of Japan, Tokyo Women's Medical University, Tokyo, Japan.
authors.forename: Junichi
authors.initials: J
authors.lastname: Yamaguchi
authors.affiliation: Department of General and Community Medicine, Kumamoto University Hospital, Kumamoto, Japan.
authors.forename: Kunihiko
authors.initials: K
authors.lastname: Matsui
authors.affiliation: Department of Cardiology, The Heart Institute of Japan, Tokyo Women's Medical University, Tokyo, Japan.
authors.forename: Nobuhisa
authors.initials: N
authors.lastname: Hagiwara
mesh_terms: D054058:Acute Coronary Syndrome / Q000097:blood / Q000150:complications / Q000000981:diagnostic imaging / Q000517:prevention & control*; D000368:Aged; D008078:Cholesterol, LDL / Q000097:blood; D017023:Coronary Angiography; D004359:Drug Therapy, Combination; D000069438:Ezetimibe / Q000627:therapeutic use*; D005260:Female; D006801:Humans; D019161:Hydroxymethylglutaryl-CoA Reductase Inhibitors / Q000627:therapeutic use*; D006949:Hyperlipidemias / Q000150:complications* / Q000188:drug therapy*; D000960:Hypolipidemic Agents / Q000627:therapeutic use*; D007564:Japan; D008297:Male; D008875:Middle Aged; D011446:Prospective Studies; D011804:Quinolines / Q000627:therapeutic use*
chemical_list: D008078:Cholesterol, LDL; D019161:Hydroxymethylglutaryl-CoA Reductase Inhibitors; D000960:Hypolipidemic Agents; D011804:Quinolines; D000069438:Ezetimibe; C108475:pitavastatin
keywords: Acute coronary syndrome; Clinical trial; Ezetimibe; Lipid-lowering; Pitavastatin