Combination therapy of eicosapentaenoic acid and pitavastatin for coronary plaque regression evaluated by integrated backscatter intravascular ultrasonography (CHERRY study)—Rationale and design

• Published in: Journal of Cardiology Vol. 64; no. 3; pp. 236 - 239
• Main Authors: Watanabe, Tetsu, Miyamoto, Takuya, Miyasita, Takehiko, Shishido, Tetsuro, Arimoto, Takanori, Takahashi, Hiroki, Nishiyama, Satoshi, Hirono, Osamu, Matsui, Motoyuki, Sugawara, Shigeo, Ikeno, Eiichiro, Miyawaki, Hiroshi, Akira, Fukao, Kubota, Isao
• Format: Journal Article
• Language: English
• Published: Netherlands Elsevier Ltd 01.09.2014; Elsevier BV
• Subjects: Cardiology and Cardiovascular Medicine; Cardiovascular; Cholesterol-lowering drugs; Coronary Artery Disease; Coronary Artery Disease - diagnostic imaging; Coronary Artery Disease - drug therapy; Coronary Vessels; Coronary Vessels - diagnostic imaging; Drug Therapy, Combination; Eicosapentaenoic Acid; Eicosapentaenoic Acid - administration & dosage; Fish oils; Follow-Up Studies; Humans; Hydroxymethylglutaryl-CoA Reductase Inhibitors; Hydroxymethylglutaryl-CoA Reductase Inhibitors - administration & dosage; Intravascular ultrasound/Doppler; Plaque; Plaque, Atherosclerotic; Plaque, Atherosclerotic - diagnostic imaging; Plaque, Atherosclerotic - drug therapy; Prospective Studies; Quinolines; Quinolines - administration & dosage; Time Factors; Treatment Outcome; Ultrasonography, Interventional; Ultrasonography, Interventional - methods; Cholesterol-lowering drugs; Intravascular ultrasound/Doppler; Fish oils; Coronary artery disease; Plaque
• ISSN: 0914-5087; 1876-4738; 1876-4738
• DOI: 10.1016/j.jjcc.2013.12.008

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. 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. 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. 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.