None listed
Conditions
Interventions
Drug : 1) Treatment group (administrate with statin + ezefeno)
- Ezetimibe 10 mg/Fenofibrate 160 mg: oral, 12 weeks, once a day
- Statins in existing treatment doses: oral, 12 weeks, once a day
2) Ref
Sponsors
Yonsei University, Wonju Severance Christian Hospital
Eligibility
Sex/Gender
All
Inclusion criteria
Inclusion criteria: 1. Age 19-80 years 2. Documented cardiovascular disease (at least one of the following) - coronary artery disease - atherosclerotic ischemic stroke - a transient cerebral ischemia attack - a carotid artery disease - peripheral arterial disease - abdominal aortic aneurysm - Diabetes (with more than 10 years of prevalence or major cardiovascular disease risk factors* or target organ damage**) 3. Remnant cholesterol > 30mg/dL for statins
Exclusion criteria
Exclusion criteria: 1) A person who has a history of allergic or hypersensitivity reactions to pharmaceutical ingredients (statin series, ezetimibe, phenofibrate) 2) Pregnant and lactating women 3) A person whose life expectancy is less than two years at the time of screening 4) A person identified as having gallbladder disease requiring treatment 5) a patient with myopathy or rhabdomyolysis 6) Those who have genetic problems such as galactose intolerance, Lapplactase deficiency, or glucose-galactosomalabsorption 7) Patients with severe liver or renal impairment such as - When ALT or AST levels are more than three times the upper limit of normal - Patients with chronic kidney failure (Estimulated glomerular filtration rate (eGFR) <30 mL/min/1.73 m2 by the Chronic Kidney Disease Epidemiology Collaboration (CKD-EPI) formula) or kidney transplant 8) a person who has received a solid organ transplant 9) A person who has a clinically significant medical history that is deemed inappropriate to participate in this clinical trial according to the judgment of the person in charge of testing 10) A person deemed unfit to participate in this clinical trial at the judgment of the person in charge of testing for other reasons
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| change(%) of remnant cholesterol | — |
Secondary
| Measure | Time frame |
|---|---|
| change(%) and amount of change in volume of Total cholesterol;change(%) and amount of change in volume of Triglyceride ;change(%) and amount of change in volume of HDL-C;change(%) and amount of change in volume of LDL-C;change(%) and amount of change in volume of Non-HDL-C;change(%) and amount of change in volume of Apolipoprotein A-1;change(%) and amount of change in volume of Apolipoprotein B;change(%) and amount of change in volume of Apo B/A1 Ratio;Type 2 diabetes morbidity;Change(%) of Weight, BMI, Waist / Hip Circumference | — |
Countries
Korea, Republic of
Contacts
Public ContactJung-hee Lee
Yonsei University, Wonju Severance Christian Hospital
Outcome results
None listed