Effects of high-dose STatin versus low-dose statin plus ezetimibe On coronary atherosclerotic Plaques
- Conditions
- Not Applicable
- Registration Number
- KCT0004325
- Lead Sponsor
- Kangbuk Samsung Medical Center
- Brief Summary
Not available
- Detailed Description
Not available
Recruitment & Eligibility
- Status
- Recruiting
- Sex
- All
- Target Recruitment
- 300
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 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.
Study & Design
- Study Type
- Interventional Study
- Study Design
- Not specified
- Primary Outcome Measures
Name Time Method 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 Outcome Measures
Name Time Method 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)