NCT02232360

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

The Comparative Analysis of the Effects on Plaque Volume and Tissue Characteristics Between Combined Therapy With STAatin Plus FENOfibrate and Statin Alone in Mild to Moderate, Non- Intervened Coronary Artery Stenosis (STAFENO Trial)

• Status: Unknown
• Phase: Phase 4
• Study type: Interventional
• Enrollment: 106 (estimated)
• Sponsor: Gachon University Gil Medical Center · Academic / Other
• Sex: All
• Age: 20 Years
• Healthy volunteers: Not accepted

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.

Detailed 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.

Conditions

• Coronary Artery Disease

Interventions

Type	Name	Description
DRUG	Rosuvastatin and fenofibrate	Combination therapy: rosuvastatin 10 mg and fenofibrate 160 mg per day
DRUG	Rosuvastatin alone	Rosuvastatin 10mg per day

Timeline

• Start date: 2014-01-01
• Primary completion: 2020-12-01
• Completion: 2020-12-01
• First posted: 2014-09-05
• Last updated: 2019-05-15

Locations

6 sites across 1 country: South Korea