The effect of usual dose rosuvastatin plus ezetimibe versus high-dose rosuvastatin on coronary atherosclerotic plaque
- Conditions
- Diseases of the circulatory system
- Registration Number
- KCT0003092
- Lead Sponsor
- Samsung Medical Center
- Brief Summary
Not available
- Detailed Description
Not available
Recruitment & Eligibility
- Status
- Recruiting
- Sex
- All
- Target Recruitment
- 280
? Subject age 18 years old or more
? Among patients who undergo coronary angiography 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 (fractional flow reserve, coronary flow reserve, index of microvascular resistance) or radiologic (intravascular resistance with or without optical coherence tomography) evaluation.
? Agreement obtained by participant
? 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 creatine kinase elevation > 3 times upper limit of normal 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
Study & Design
- Study Type
- Interventional Study
- Study Design
- Not specified
- Primary Outcome Measures
Name Time Method Change in percent atheroma volume
- Secondary Outcome Measures
Name Time Method Change in normalized total atheroma volume;Change in indexed total atheroma volume;Change in fibrous cap thickness by optical coherence tomography;Change in fractional flow reserve;Change in coronary flow reserve;Change in index of microcirculatory resistance;Change in total atheroma volume in coronary computed tomography angiography;Major adverse cardiovascular events;Change in homeostatic model assessment index;Change in fasting glucose;Change in hemoglobin A1c;Change in lipid profile (triglyceride, high-density lipoprotein, low-density lipoprotein);Change in high-sensitivity C-reactive protein;Safety endpoint: Number of participants with abnormal laboratory values (creatine kinase, hepatic transaminase) and adverse events