Effects of Combined Therapy With Statin Plus Fenofibrate on Coronary Atherosclerotic Plaque Compared With Statin Alone

• Status: Unknown status
• Trial end date: 2020-12-01
• Target enrollment: 0
• Participant gender: All

Summary

The purpose of this study is to determine effects of combination therapy with rosuvastatin and fenofibrate on atheromatous plaques and its tissue characteristics of de novo coronary lesions with intermediate stenosis in patient with coronary artery disease, compared with rosuvastatin alone therapy.

• Phase: Phase 4
• Accepts Healthy Volunteers?: No

Details

• Lead Sponsor: Gachon University Gil Medical Center
• Collaborator: Daewoong Pharmaceutical Co. LTD.
• Treatments: Fenofibrate; Rosuvastatin Calcium

Criteria

Inclusion Criteria:

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

• 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) in which virtual histology-intravascular ultrasound (VH-IVUS) could be feasible

• Combined dyslipidemia

• Stain-naive patients - LDL-cholesterol ≥70 mg/dL and non-HDL-cholesterol ≥130 mg/dL

• Patients taking statin within 2 weeks - LDL-cholesterol < 100 mg/dL and non-HDL-cholesterol ≥100 mg/dL

• Patients who gave written informed consent

Exclusion Criteria:

• Diabetic patients

• Cardiogenic shock

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

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

• Hepatic dysfunction (transaminase level > 3 times of normal within limit)

• Pregnancy or breast-feeding women

• Familial hypercholesterolemia

• Hypertriglyceridemia (triglyceride level >500 mg/dL)