title: Combination therapy of eicosapentaenoic acid and pitavastatin for coronary plaque regression evaluated by integrated backscatter intravascular ultrasonography (CHERRY study)-rationale and design.
abstract: OBJECTIVE
  Many clinical trials have shown that 3-hydroxy-3-methylglutaryl-coenzyme A (HMG-CoA) reductase inhibitors (statins) can significantly reduce coronary artery disease in both primary and secondary prevention. A recent study showed that aggressive lipid-lowering therapy with strong statins could achieve coronary artery plaque regression, as evaluated with gray-scale intravascular ultrasound (IVUS). However, it is unknown whether coronary plaque regression and stabilization are reinforced when eicosapentaenoic acid (EPA) is used with a strong statin.
  
  
  METHODS
  We aim to assess patients with stable angina or acute coronary syndrome who had undergone successful percutaneous coronary intervention (PCI) with integrated backscatter IVUS (IB-IVUS) guidance. They will be randomly allocated to receive pitavastatin (4mg), or pitavastatin (4mg) plus EPA (1800mg), and prospectively followed for 6-8 months.
  
  
  RESULTS
  The primary endpoint will be changes in tissue characteristics in coronary plaques, evaluated by IB-IVUS, and secondary endpoints will include absolute changes in coronary plaque volume, serum lipid levels, and inflammatory markers. The safety profile will also be evaluated.
  
  
  CONCLUSIONS
  The combination therapy of EPA and pitavastatin for regression of coronary plaque evaluated by IB-IVUS (CHERRY) study will be the first multicenter study using IB-IVUS to investigate the effects of combination therapy with pitavastatin and EPA on coronary plaque volume and tissue characteristics.
authors: Department of Cardiology, Pulmonology, and Nephrology, Yamagata University School of Medicine, Yamagata, Japan. Electronic address: tewatana@med.id.yamagata-u.ac.jp.
authors: Tetsu
authors: T
authors: Watanabe
authors: Department of Cardiology, Pulmonology, and Nephrology, Yamagata University School of Medicine, Yamagata, Japan.
authors: Takuya
authors: T
authors: Miyamoto
authors: Department of Cardiology, Pulmonology, and Nephrology, Yamagata University School of Medicine, Yamagata, Japan.
authors: Takehiko
authors: T
authors: Miyasita
authors: Department of Cardiology, Pulmonology, and Nephrology, Yamagata University School of Medicine, Yamagata, Japan.
authors: Tetsuro
authors: T
authors: Shishido
authors: Department of Cardiology, Pulmonology, and Nephrology, Yamagata University School of Medicine, Yamagata, Japan.
authors: Takanori
authors: T
authors: Arimoto
authors: Department of Cardiology, Pulmonology, and Nephrology, Yamagata University School of Medicine, Yamagata, Japan.
authors: Hiroki
authors: H
authors: Takahashi
authors: Department of Cardiology, Pulmonology, and Nephrology, Yamagata University School of Medicine, Yamagata, Japan.
authors: Satoshi
authors: S
authors: Nishiyama
authors: Yamagata Prefectural Shinjyo Hospital, Yamagata, Japan.
authors: Osamu
authors: O
authors: Hirono
authors: Yamagata Prefectural Central Hospital, Yamagata, Japan.
authors: Motoyuki
authors: M
authors: Matsui
authors: Nihonkai General Hospital, Yamagata, Japan.
authors: Shigeo
authors: S
authors: Sugawara
authors: Okitama Public General Hospital, Yamagata, Japan.
authors: Eiichiro
authors: E
authors: Ikeno
authors: Yamagata City Hospital Saiseikan, Yamagata, Japan.
authors: Hiroshi
authors: H
authors: Miyawaki
authors: Department of Public Health, Yamagata University School of Medicine, Yamagata, Japan.
authors: Fukao
authors: F
authors: Akira
authors: Department of Cardiology, Pulmonology, and Nephrology, Yamagata University School of Medicine, Yamagata, Japan.
authors: Isao
authors: I
authors: Kubota
mesh_terms: D003324:Coronary Artery Disease / Q000000981:diagnostic imaging / Q000188:drug therapy*; D003331:Coronary Vessels / Q000000981:diagnostic imaging*; D004359:Drug Therapy, Combination; D015118:Eicosapentaenoic Acid / Q000008:administration & dosage*; D005500:Follow-Up Studies; D006801:Humans; D019161:Hydroxymethylglutaryl-CoA Reductase Inhibitors / Q000008:administration & dosage*; D058226:Plaque, Atherosclerotic / Q000000981:diagnostic imaging / Q000188:drug therapy*; D011446:Prospective Studies; D011804:Quinolines / Q000008:administration & dosage*; D013997:Time Factors; D016896:Treatment Outcome; D018084:Ultrasonography, Interventional / Q000379:methods*
chemical_list: D019161:Hydroxymethylglutaryl-CoA Reductase Inhibitors; D011804:Quinolines; D015118:Eicosapentaenoic Acid; C108475:pitavastatin
keywords: Cholesterol-lowering drugs; Coronary artery disease; Fish oils; Intravascular ultrasound/Doppler; Plaque