None listed
Conditions
Interventions
Drug : Definition of Random Assignments
Rosuvastatin group (Test drug 1): Patients receiving high-dose rosuvastatin once daily
Rosuvamib (Test Drug 2): Patients who receive low-dose statins and ezetim
Sponsors
Kangbuk Samsung Medical Center
Eligibility
Sex/Gender
All
Inclusion criteria
Inclusion criteria: Participants in this study should meet all of the following selection criteria. 1) Those who are 18 years of age or older on the consent date 2) Stable coronary artery disease with moderate or more significant stenosis in the main coronary artery on CT (> 50% internal stenosis). 3) Patients or agents who have agreed to the study plan and clinical and coronary computed tomography follow-up, and have previously agreed in writing to the clinical trial subject autonomy approved by the research institution's research review committee / ethics committee.
Exclusion criteria
Exclusion criteria: Exclusion Criteria for Clinical Subjects Subjects who meet any of the following exclusion criteria cannot participate in this study. 1) unstable angina or acute myocardial infarction 2) If you have undergone coronary stent surgery or coronary artery bypass surgery 3) If you have chronic kidney disease (eGFR <60ml / min) 4) Cardiac surgery or major surgery is planned within the last 6 months 5) Patients with chronic diseases such as cirrhosis, severe lung disease, hard stroke 6) Patients with chronic inflammatory diseases requiring oral, intravenous or intraarticular steroid treatment (Ointments, inhalants, or intranasal steroids are allowed.) 7) Have been diagnosed with cancer (except superficial squamous cell / basal cell skin cancer) within the past 3 years or currently undergoing chemotherapy 8) There are clinically significant abnormal findings that may violate the safety of the study by the investigator's judgment confirmed by screening visit, physical examination, blood test or ECG test. 9) Hepatic insufficiency or cholestatic obstruction or liver enzyme level (ALT / AST) is more than three times normal 10) You have a history of asthma from bronchial spasms within the last 6 months or you are currently taking regular anti-asthma medicine 11) If you have a disease with a life expectancy of 2 years or less 12) If the procedures described in the protocol are not desired or cannot be followed. 13) Pregnant women, lactating women, women of childbearing age who do not use reliable contraceptive methods or who do not agree to maintain contraception during clinical trials.
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| The primary endpoint in this study was the percent change in total atheroma volume (TAV) of the lesion site (region of interest with assessable moderate stenosis) 24 months after the study drug administration. [(TAV at 24 months – TAV at baseline) / (TAV at baseline) X100] | — |
Secondary
| Measure | Time frame |
|---|---|
| Absolute change of TAV (Total atheroma volume) at 24 months;Absolute change of PAV (percent atheroma volume) at 24 months;overall CAC score at 24 months;Score Change of Calcium density score (Agatston score/volume score) | — |
Countries
Korea, Republic of
Contacts
Public ContactJong-Young LEE
Kangbuk Samsung Medical Center
Outcome results
None listed