This study aim is to evaluate the additional effect of eicosapentaenoic acid and dose up effect of rosuvastatin for neoatherosclerosis in coronary artery disease patients.
Eicosapentaenoic acid and statin therapy prevents cardiovascular events. However, the impact of these treatment in patients with in-stent neoatherosclerosis has not been clarified. So, the investigators conducted LINK IT study. This study showed that eicosapentaenoic acid(EPA) and rosuvastatin therapy improve lipid index in patients compared with rosuvastatin alone therapy. However, it was insufficient to directly evaluate the efficacy of additional effect of EPA for neoatherosclerosis. Because, statin dose of two groups was different and type of stent was variety. Therefore, the investigators designed a new prospective, randomized OCT study. The OCT operators randomly assigned 75 patients who were detected neoatherosclerosis on follow-up OCT examination after implanted everolimus eluting stent to three groups; 5mg/day of rosuvastatin therapy (low dose statin therapy group) or 10mg/day of rosuvastatin therapy (high dose statin therapy group) or 10mg/day of rosuvastatin and 1800mg/day of eicosapentaenoic acid therapy (EPA and statin therapy group). Serial coronary angiography and OCT were performed at 9 months after baseline OCT procedure. This study aim is to evaluate the additional effect of eicosapentaenoic acid and dose up effect of rosuvastatin for neoatherosclerosis in coronary artery disease patients by comparing 3 groups.
Study Type
INTERVENTIONAL
Allocation
RANDOMIZED
Purpose
TREATMENT
Masking
NONE
Enrollment
75
To take EPA (1800mg/day) and high dose rosuvastatin (10mg/day) for 9 months.
To take high dose rosuvastatin (10mg/day) for 9 months.
Kobe University Graduate School of Medicine, Department of Cardiology
Kobe, Hyōgo, Japan
The change in lipid index
mean lipid arc ✕ lipid length
Time frame: 9 months
MACE
Major cerebro-cardiovascular events(Nonfatal stroke, Nonfatal myocardial infarction, cardiovascular death)
Time frame: 9 months
The change in minimum lumen area
OCT parameter
Time frame: 9 months
The change in average neointimal thickness
OCT parameter
Time frame: 9 months
The change in lipid arc
OCT parameter
Time frame: 9 months
The change in lipid length
OCT parameter
Time frame: 9 months
The change in thin cap fibroatheroma
OCT parameter
Time frame: 9 months
The change in macrophage grade
OCT parameter
Time frame: 9 months
The change in plaque volume
Near infrared spectroscopy intravascular ultrasound(NIRS-IVUS) parameter
Time frame: 9 months
The change in max Lipid-core burden index
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NIRS-IVUS parameter
Time frame: 9 months