Usual Dose Rosuvastatin Plus Ezetimibe Versus High-dose Rosuvastatin on Coronary Atherosclerotic Plaque (Rosuzet-IVUS)
Coronary Artery Disease
About this trial
This is an interventional treatment trial for Coronary Artery Disease focused on measuring Rosuvastatin, Ezetimibe, Atherosclerotic plaque, Intravascular ultrasound
Eligibility Criteria
Inclusion Criteria:
Among patients who undergo CAG for suspected ischemic heart disease and meet all of the followings:
- Moderate stenosis (30-70%) in coronary artery
- Deferred to medical treatment based on physiologic (FFR, CFR, IMR) or radiologic (IVUS with or without OCT) evaluation.
- Agreement obtained by participant
Exclusion Criteria:
- Severe renal failure(glomerular filtration rate < 30 ml/min/1.73m2, hemodialysis or peritoneal dialysis)
- Active liver disease
- Patient taking Niacin or fibrate(if possible, patient can be enrolled to the study after stopping those medication)
- Medical or family history of myositis, unexplained CK elevation > 3 times ULN at first visit
- Life expectancy < 2 years (judged by investigator)
- Coadministration of cyclosporine
- Untreated hypothyroidism
- Patient with poor compliance including alcohol abuse
- History of hypersensitivity including myotoxicity for either statin or ezetimibe
- Pregnant or breast-feeding woman
Other conditions inappropriate for enrollment by investigator
- * Eligible patients will be randomly assigned to treatment arms, stratified by diagnosis on admission(acute coronary syndrome or stable ischemic heart disease) and presence of chronic statin use (more than one month)
Sites / Locations
- Samsung Medical CenterRecruiting
Arms of the Study
Arm 1
Arm 2
Active Comparator
Active Comparator
Rosuvastatin plus ezetimibe arm
High-dose rosuvastatin monotherapy arm
In patients who have moderate stenosis(30-70%) in coronary artery and deferred to medical treatment by intracoronary physiologic or radiologic test, this arm will be received rosuvastatin 10 mg plus ezetimibe 10 mg qd during 12 months after randomization.
In patients who have moderate stenosis(30-70%) in coronary artery and deferred to medical treatment by intracoronary physiologic or radiologic test, this arm will be received rosuvastatin 20 mg qd during 12 months after randomization.