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

Gachon University Gil Medical Center

Status and phase: Unknown; Phase 4

Conditions: Coronary Artery Disease

Treatments: Drug: Rosuvastatin alone; Drug: Rosuvastatin and fenofibrate

Study type: Interventional

Funder types: Other; Industry

Identifiers

NCT02232360

STAFENO

Details and patient eligibility

About

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.

Full description

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.

Enrollment: 106 estimated patients

Sex: All

Ages: 20+ years old

Volunteers: No Healthy Volunteers

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)

Trial design

Primary purpose: Treatment

Allocation: Randomized

Interventional model: Parallel Assignment

Masking: None (Open label)

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106 participants in 2 patient groups

Rosuvastatin and fenofibrate

Experimental group

Description:

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

Treatment:

Drug: Rosuvastatin and fenofibrate

Rosuvastatin alone

Active Comparator group

Description:

Rosuvastatin 10 mg per day

Treatment:

Drug: Rosuvastatin alone