None listed
Conditions
Interventions
Drug : Experimental Drug: combination drug of Ezetimibe 10 mg/Rosuvastatin 5 mg,once a day, by mouth
Control Drug: Rosuvastatin mono-administration 20 mg, once a day, by mouth
Sponsors
The Catholic University of Korea, Seoul St. Mary's Hospital
Eligibility
Sex/Gender
All
Inclusion criteria
Inclusion criteria: 1)Adults Aged 19 and up 2)Patients diagnosed with myocardial infarction (both ST segment elevation and non-ST segment elevation) who were treated with percutaneous coronary intervention (Myocardial infarction defined as in the 4th Universal Definition of Myocardial Infarction) 3)For female patients who are of childbearing age, subjects that agreed on taking mandatory pregnancy test 4)Patients who agreed and signed on the informed consent form 5)Patients who were taking statin's lipid-reducing agent before myocardial infarction can be included in clinical trials by changing existing drugs.
Exclusion criteria
Exclusion criteria: 1)Patients with life expectancy of a year or less due to malignancy 2)Patients with chronic liver disease 3)Patients with sensitivity to active ingredient of the research drugs (ezetimibe and/or rosuvastatin) or patients who are prohibited to take ezetimibe and/or rosuvastatin. 4)Pregnant and/or breastfeeding 5)Female patients who are unable to use any means of contraception 6)Patients receiving hemodialysis, peritoneal dialysis patients and/or kidney transplant patients, due to end stage renal disease 7)Patients who participated in other clinical trial(s) within 3 months after the screening (except non-interventional observational study) 8)Patients considered unfit for the study for any other reason(s) by the investigator
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| Complex assessment variable including cardiovascular deaths, non-fatal myocardial infarction, ischemic stroke and hospitalization due to unstable angina within 2 years from treatment | — |
Secondary
| Measure | Time frame |
|---|---|
| incidence rates of cardiac deaths, total deaths, nonfatal myocardial infarction, nonfatal ischemic stroke, hospitalization due to unstable angina, revascularization of each group. Assess analytical test using t-test for difference in incidence rates between the tested group and control group.;Achievement rate of LDL cholesterol level less than 70mg/dL;Statin Associated Muscle Symptom questionnaire;serious cardiovascular adverse event and adverse events caused by tested drug(s);laboratory test, physical examination during the trial | — |
Countries
Korea, Republic of
Contacts
Public Contactjae lee
The Catholic University of Korea, Seoul St. Mary's Hospital
Outcome results
None listed