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Table 1 Inclusion and exclusion criteria

From: Design and rationale of a randomized control trial testing the effectiveness of combined therapy with STAtin plus FENOfibrate and statin alone in non-diabetic, combined dyslipidemia patients with non-intervened intermediate coronary artery disease - STAFENO study

Inclusion criteria

• Patients with coronary artery disease who were 20 years of age or older and required coronary angiography

• Patients who require PCI in culprit lesions

• Intermediate coronary artery stenosis (diameter stenosis ≥ 30% to ≤ 60% by visual estimation, diameter ≥ 2.0 mm to ≤ 4.0 mm, de novo lesion in native coronary artery, more than 10 mm distance from PCI sites) in which virtual histology-intravascular ultrasound (VH-IVUS) is feasible

• Statin naïve subjects: Combined dyslipidemia (LDLc ≥ 70 mg/dL and non-HDLc ≥ 130 mg/dL)

• In statin subjects: LDLc ≤ 100 mg and non-HDLc ≥ 100 mg/dL

• Patients who provided written informed consent

Exclusion criteria

• Diabetic patients

• Patients with a history of the use of other lipid-modifying agents (except statins) within the 2 weeks prior to the trial beginning

• Cardiogenic shock

• Heart failure with symptoms of New York Heart Association class III/IV or a left ventricular ejection fraction < 35%

• Renal dysfunction (creatinine level ≥ 1.7 mg/dL) or dependence of dialysis

• Hepatic dysfunction (transaminase level more than three times that of the normal limit)

• Pregnancy or breastfeeding women or women of childbearing age

• Familial hypercholesterolemia

• Hypertriglyceridemia (triglyceride level > 500 mg/dL)

• Lesions that might cause difficulties for VH-IVUS due to the following reasons: heavy calcification (> 90° arc), tortuous vessel with severe angulation, total occlusion, or major bifurcation lesions (side branch diameter > 2 mm)

• Inability to take adequate antiplatelet therapy (aspirin, clopidogrel, ticagrelor, or prasugrel)

• Thrombocytopenia (platelet count < 70 × 109/L)

• History of significant arrhythmia including ventricular tachyarrhythmia

• Familial hypercholesterolemia