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

Gachon University Gil Medical Center106 enrolled

Overview

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.

Cardiovascular disease remains the leading cause of morbidity and mortality worldwide. In the past few decades, optimal pharmacological therapies with statins targeting LDL-cholesterol substantially reduce the risks of cardiovascular disease. However, the residual cardiovascular risk is still high, requiring need for additional preventive therapies to achieve even greater risk reduction. Recent meta-analysis demonstrated fibrates can reduce the risk of coronary events and might have a role in patients with high cardiovascular risks or combined dyslipidemia. Likewise, fenofibrate had a possible benefit for patients with high triglyceride level and low HDL-cholesterol level in the post-hoc analysis of ACCORD or FIELD trials. Thus, investigators tried 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.

Study Type

INTERVENTIONAL

Allocation

RANDOMIZED

Purpose

TREATMENT

Masking

NONE

Enrollment

106

Conditions

Coronary Artery Disease

Interventions

Rosuvastatin and fenofibrateDRUG

Combination therapy: rosuvastatin 10 mg and fenofibrate 160 mg per day

Rosuvastatin aloneDRUG

Rosuvastatin 10mg per day

Eligibility

Sex: ALLMin age: 20 Years

Medical Language ↔ Plain English

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)

Locations (6)

Konyang University Hospital

Daejeon, South Korea

NOT_YET_RECRUITING

Chonnam National University Medical School and Hospital

Gwangju, South Korea

RECRUITING

Inje University ilsanPaik Hospital

Ilsan, South Korea