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

Coronary Artery Disease Clinical Trial

Official title:

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)

Clinical Trial Details — Status: Recruiting

Administrative data

• NCT number: NCT02232360
• Other study ID #: STAFENO
• Status: Recruiting
• Phase: Phase 4
• Start date: January 2014
• Est. completion date: December 2020

Study information

• Verified date: May 2019
• Source: Gachon University Gil Medical Center
• Contact: Seung Hwan Han, MD
• Phone: 82-32-460-3054
• Email: shhan[@]gilhospital.com
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial 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.

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.

Recruitment information / eligibility

• Status: Recruiting
• Enrollment: 106
• Est. completion date: December 2020
• Est. primary completion date: December 2020
• Accepts healthy volunteers: No
• Gender: All
• Age group: 20 Years and older

Eligibility

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)

Related Conditions & MeSH terms

• Coronary Artery Disease
• Coronary Disease
• Myocardial Ischemia
• Plaque, Atherosclerotic

Intervention

Drug:
• Rosuvastatin and fenofibrate
Combination therapy: rosuvastatin 10 mg and fenofibrate 160 mg per day
• Rosuvastatin alone
Rosuvastatin 10mg per day

Locations

Country	Name	City	State
Korea, Republic of	Konyang University Hospital	Daejeon
Korea, Republic of	Chonnam National University Medical School and Hospital	Gwangju
Korea, Republic of	Inje University ilsanPaik Hospital	Ilsan
Korea, Republic of	Gachon University Gil Medical Center	Incheon
Korea, Republic of	Chung-Ang University Hospital	Seoul
Korea, Republic of	Seoul National Univesity Boramae Medical Center	Seoul

Sponsors (2)

Lead Sponsor	Collaborator
Gachon University Gil Medical Center	Daewoong Pharmaceutical Co. LTD.

Country where clinical trial is conducted

Korea, Republic of, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Percent and Absolute changes of Necrotic Core volume in non-culprit intermediate lesions	Percent and Absolute changes of Necrotic Core volume in non-culprit intermediate lesions by VH-IVUS	After 12±2 months treatment
Secondary	Percent and Absolute changes of area of necrotic core, dense calcium, fibrous plaque in non-culprit intermediate lesions	Percent and Absolute changes of area of necrotic core, dense calcium, fibrous plaque in non-culprit intermediate lesions by VH-IVUS	After 12±2 months treatment
Secondary	Presence of thin-cap fibroatheroma	change of plaque phenotype by VH-IVUS	After 12±2 months treatment
Secondary	Absolute and percent changes of volume/area of external elastic membrane, lumen and plaque volume	Absolute and percent changes of volume/area of external elastic membrane, lumen and plaque volume by VH-IVUS	After 12±2 months treatment
Secondary	Remodeling index	Remodeling index by VH-IVUS	After 12±2 months treatment
Secondary	Major adverse cardiovascular events (MACE)	The composites of all-cause death, non-fatal myocardial infarction, stroke, culprit lesion revascularization, or non-culprit lesion revascularization	After 12 months treatment
Secondary	Adverse drug events	Adverse drug events related by study drugs	After 12±2 months treatment
Secondary	Creatine phosphokinase	measurement of muscular side effects related by study drugs	After 12±2 months treatment