Coronary Artery Disease
Conditions
Keywords
Atherosclerotic plaque, Virtual histology intravascular ultrasound, Plaque composition, Rosuvastatin, Fenofibrate, Coronary artery disease
Brief 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.
Interventions
DRUGRosuvastatin and fenofibrate
Combination therapy: rosuvastatin 10 mg and fenofibrate 160 mg per day
DRUGRosuvastatin alone
Rosuvastatin 10mg per day
Sponsors
Daewoong Pharmaceutical Co. LTD.
Gachon University Gil Medical Center
Study design
Allocation
RANDOMIZED
Intervention model
PARALLEL
Primary purpose
TREATMENT
Masking
NONE
Eligibility
Sex/Gender
ALL
Age
20 Years to No maximum
Healthy volunteers
No
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)
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| Percent and Absolute changes of Necrotic Core volume in non-culprit intermediate lesions | After 12±2 months treatment | Percent and Absolute changes of Necrotic Core volume in non-culprit intermediate lesions by VH-IVUS |
Secondary
| Measure | Time frame | Description |
|---|---|---|
| Presence of thin-cap fibroatheroma | After 12±2 months treatment | change of plaque phenotype by VH-IVUS |
| Absolute and percent changes of volume/area of external elastic membrane, lumen and plaque volume | After 12±2 months treatment | Absolute and percent changes of volume/area of external elastic membrane, lumen and plaque volume by VH-IVUS |
| Remodeling index | After 12±2 months treatment | Remodeling index by VH-IVUS |
| Percent and Absolute changes of area of necrotic core, dense calcium, fibrous plaque in non-culprit intermediate lesions | After 12±2 months treatment | Percent and Absolute changes of area of necrotic core, dense calcium, fibrous plaque in non-culprit intermediate lesions by VH-IVUS |
| Adverse drug events | After 12±2 months treatment | Adverse drug events related by study drugs |
| Creatine phosphokinase | After 12±2 months treatment | measurement of muscular side effects related by study drugs |
| Major adverse cardiovascular events (MACE) | After 12 months treatment | The composites of all-cause death, non-fatal myocardial infarction, stroke, culprit lesion revascularization, or non-culprit lesion revascularization |
Countries
South Korea
Contacts
Primary ContactSeung Hwan Han, MD
Backup ContactPyung Chun Oh, MD
Outcome results
None listed