title: Plaque REgression with Cholesterol absorption Inhibitor or Synthesis inhibitor Evaluated by IntraVascular UltraSound (PRECISE-IVUS Trial): Study protocol for a randomized controlled trial.
abstract: BACKGROUND
  Although the positive association between achieved low-density lipoprotein cholesterol (LDL-C) level and the risk of coronary artery disease (CAD) has been confirmed by randomized studies with statins, many patients remain at high residual risk of events suggesting the necessity of novel pharmacologic strategies. The combination of ezetimibe/statin produces greater reductions in LDL-C compared to statin monotherapy.
  
  
  OBJECTIVE
  The Plaque REgression with Cholesterol absorption Inhibitor or Synthesis inhibitor Evaluated by IntraVascular UltraSound (PRECISE-IVUS) trial was aimed at evaluating the effects of ezetimibe addition to atorvastatin, compared with atorvastatin monotherapy, on coronary plaque regression and change in lipid profile in patients with CAD.
  
  
  METHODS
  The study is a prospective, randomized, controlled, multicenter study. The eligible patients undergoing IVUS-guided percutaneous coronary intervention will be randomly assigned to receive either atorvastatin alone or atorvastatin plus ezetimibe (10 mg) daily using a web-based randomization software. The dosage of atorvastatin will be increased by titration within the usual dose range with a treatment goal of lowering LDL-C below 70 mg/dL based on consecutive measures of LDL-C at follow-up visits. IVUS will be performed at baseline and 9-12 months follow-up time point at participating cardiovascular centers. The primary endpoint will be the nominal change in percent coronary atheroma volume measured by volumetric IVUS analysis.
  
  
  CONCLUSIONS
  PRECISE-IVUS will assess whether the efficacy of combination of ezetimibe/atorvastatin is noninferior to atorvastatin monotherapy for coronary plaque reduction, and will translate into increased clinical benefit of dual lipid-lowering strategy in a Japanese population.
authors.affiliation: Department of Cardiovascular Medicine, Graduate School of Medical Sciences, Kumamoto University, Kumamoto, Japan. Electronic address: tsujita@kumamoto-u.ac.jp.
authors.forename: Kenichi
authors.initials: K
authors.lastname: Tsujita
authors.affiliation: Jinnouchi Hospital, Kumamoto, Japan.
authors.forename: Seigo
authors.initials: S
authors.lastname: Sugiyama
authors.affiliation: Division of Cardiology, Kumamoto Central Hospital, Kumamoto, Japan.
authors.forename: Hitoshi
authors.initials: H
authors.lastname: Sumida
authors.affiliation: Department of Cardiovascular Medicine, Fukuoka Tokushukai Medical Center, Kasuga, Japan.
authors.forename: Hideki
authors.initials: H
authors.lastname: Shimomura
authors.affiliation: Division of Cardiology, Social Insurance Omuta Tenryo Hospital, Omuta, Japan.
authors.forename: Takuro
authors.initials: T
authors.lastname: Yamashita
authors.affiliation: Department of Cardiovascular Medicine, Graduate School of Medical Sciences, Kumamoto University, Kumamoto, Japan.
authors.forename: Kenshi
authors.initials: K
authors.lastname: Yamanaga
authors.affiliation: Department of Cardiovascular Medicine, Graduate School of Medical Sciences, Kumamoto University, Kumamoto, Japan.
authors.forename: Naohiro
authors.initials: N
authors.lastname: Komura
authors.affiliation: Department of Cardiovascular Medicine, Graduate School of Medical Sciences, Kumamoto University, Kumamoto, Japan.
authors.forename: Kenji
authors.initials: K
authors.lastname: Sakamoto
authors.affiliation: Department of Cardiovascular Medicine, Graduate School of Medical Sciences, Kumamoto University, Kumamoto, Japan.
authors.forename: Takamichi
authors.initials: T
authors.lastname: Ono
authors.affiliation: Division of Cardiology, Health Insurance Hitoyoshi General Hospital, Hitoyoshi, Japan.
authors.forename: Hideki
authors.initials: H
authors.lastname: Oka
authors.affiliation: Division of Cardiology, Saiseikai Kumamoto Hospital Cardiovascular Center, Kumamoto, Japan.
authors.forename: Koichi
authors.initials: K
authors.lastname: Nakao
authors.affiliation: Interventional Cardiology Unit, New Tokyo Hospital, Matsudo, Japan.
authors.forename: Sunao
authors.initials: S
authors.lastname: Nakamura
authors.affiliation: Department of Cardiovascular Medicine, National Cerebral and Cardiovascular Center, Suita, Japan.
authors.forename: Masaharu
authors.initials: M
authors.lastname: Ishihara
authors.affiliation: Department of General Medicine, Yamaguchi University Hospital, Ube, Japan.
authors.forename: Kunihiko
authors.initials: K
authors.lastname: Matsui
authors.affiliation: Division of Cardiology, Amakusa Medical Center, Amakusa, Japan.
authors.forename: Naritsugu
authors.initials: N
authors.lastname: Sakaino
authors.affiliation: Division of Cardiology, Shin-Beppu Hospital, Beppu, Japan.
authors.forename: Natsuki
authors.initials: N
authors.lastname: Nakamura
authors.affiliation: Division of Cardiology, Miyazaki Prefectural Nobeoka Hospital, Nobeoka, Japan.
authors.forename: Nobuyasu
authors.initials: N
authors.lastname: Yamamoto
authors.affiliation: Division of Cardiology, Health Insurance Kumamoto General Hospital, Yatsushiro, Japan.
authors.forename: Shunichi
authors.initials: S
authors.lastname: Koide
authors.affiliation: Division of Cardiology, Japan Labor Health and Welfare Organization Kumamoto Rosai Hospital, Yatsushiro, Japan.
authors.forename: Toshiyuki
authors.initials: T
authors.lastname: Matsumura
authors.affiliation: National Hospital Organization Kumamoto Medical Center, Kumamoto, Japan.
authors.forename: Kazuteru
authors.initials: K
authors.lastname: Fujimoto
authors.affiliation: Japanese Red Cross Kumamoto Hospital, Kumamoto, Japan.
authors.forename: Ryusuke
authors.initials: R
authors.lastname: Tsunoda
authors.affiliation: Division of Cardiology, Kumamoto City Hospital, Kumamoto, Japan.
authors.forename: Yasuhiro
authors.initials: Y
authors.lastname: Morikami
authors.affiliation: Division of Cardiology, Social Insurance Omuta Tenryo Hospital, Omuta, Japan.
authors.forename: Koushi
authors.initials: K
authors.lastname: Matsuyama
authors.affiliation: Division of Cardiology, Kumamoto Central Hospital, Kumamoto, Japan.
authors.forename: Shuichi
authors.initials: S
authors.lastname: Oshima
authors.affiliation: Department of Cardiovascular Medicine, Graduate School of Medical Sciences, Kumamoto University, Kumamoto, Japan.
authors.forename: Koichi
authors.initials: K
authors.lastname: Kaikita
authors.affiliation: Department of Cardiovascular Medicine, Graduate School of Medical Sciences, Kumamoto University, Kumamoto, Japan.
authors.forename: Seiji
authors.initials: S
authors.lastname: Hokimoto
authors.affiliation: Department of Cardiovascular Medicine, Graduate School of Medical Sciences, Kumamoto University, Kumamoto, Japan; Department of Cardiovascular Medicine, National Cerebral and Cardiovascular Center, Suita, Japan.
authors.forename: Hisao
authors.initials: H
authors.lastname: Ogawa
mesh_terms: D000328:Adult; D000368:Aged; D000369:Aged, 80 and over; D000924:Anticholesteremic Agents / Q000008:administration & dosage*; D000069059:Atorvastatin / Q000008:administration & dosage*; D008078:Cholesterol, LDL / Q000187:drug effects; D002985:Clinical Protocols; D003324:Coronary Artery Disease / Q000000981:diagnostic imaging / Q000188:drug therapy*; D004359:Drug Therapy, Combination / Q000379:methods; D000069438:Ezetimibe / Q000008:administration & dosage*; D005260:Female; D006801:Humans; D019161:Hydroxymethylglutaryl-CoA Reductase Inhibitors / Q000008:administration & dosage*; D008297:Male; D008875:Middle Aged; D062645:Percutaneous Coronary Intervention; D058226:Plaque, Atherosclerotic / Q000000981:diagnostic imaging / Q000188:drug therapy*; D011446:Prospective Studies; D018084:Ultrasonography, Interventional
chemical_list: D000924:Anticholesteremic Agents; D008078:Cholesterol, LDL; D019161:Hydroxymethylglutaryl-CoA Reductase Inhibitors; D000069059:Atorvastatin; D000069438:Ezetimibe
keywords: Ezetimibe; HMG-CoA reductase inhibitors; Intravascular ultrasound; Plaque