Status:
UNKNOWN
Effects of Combined Therapy With Statin Plus Fenofibrate on Coronary Atherosclerotic Plaque Compared With Statin Alone
Lead Sponsor:
Gachon University Gil Medical Center
Collaborating Sponsors:
Daewoong Pharmaceutical Co. LTD.
Conditions:
Coronary Artery Disease
Eligibility:
All Genders
20+ years
Phase:
PHASE4
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 inter...
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 r...
Eligibility Criteria
Inclusion
- 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
- 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)
Key Trial Info
Start Date :
January 1 2014
Trial Type :
INTERVENTIONAL
Allocation :
ESTIMATED
End Date :
December 1 2020
Estimated Enrollment :
106 Patients enrolled
Trial Details
Trial ID
NCT02232360
Start Date
January 1 2014
End Date
December 1 2020
Last Update
May 15 2019
Active Locations (6)
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1
Konyang University Hospital
Daejeon, South Korea
2
Chonnam National University Medical School and Hospital
Gwangju, South Korea
3
Inje University ilsanPaik Hospital
Ilsan, South Korea
4
Gachon University Gil Medical Center
Incheon, South Korea, 405-760