Combination therapy of rosuvastatin 5mg and ezetimibe 10 mg showed similar achievement rate in decreasing LDL cholesterol level by 50% as single use of rosuvastatin 20 mg. This trial aims to prove non-inferiority of concomitant usage of low dose rosuvastatin and ezetimibe among patients with acute myocardial infarction who went through percutaneous coronary intervention at decreasing major adverse cardiac events compared to the efficacy of single use of high dose rosuvastatin.
IMPROVE-IT (Improved Reduction of Outcomes: Vytorin Efficacy International Trial) study showed that even when statin is not used as a treatment the rate of decrease of LDL cholesterol is correlated to the risk of heart disease. Yet whether concomitant use of ezetimibe and statin will have similar degree of clinical efficacy as single use of high dose statin in decreasing LDL cholesterol level needs further examination.
Study Type
INTERVENTIONAL
Allocation
RANDOMIZED
Purpose
TREATMENT
Masking
NONE
Enrollment
3,548
Initial use of 10mg of ezetimibe combined with 5 mg of rosuvastatin
20mg of Rosuvastatin as a standard treatment for AMI patients
Bucheon St.Mary Hospital
Bucheon-si, Gyeonggido, South Korea
RECRUITINGSt.Vincent's Hospital
Suwon, Gyeonggido, South Korea
RECRUITINGUijeongbu St.Mary's Hospital
Uijeongbu-si, Gyeonggido, South Korea
RECRUITINGDaejeon St.Mary's Hospital
Daejeon, South Korea
RECRUITINGIncheon St.Mary's Hospital
Incheon, South Korea
RECRUITINGSeoul St.Mary's Hospital
Seoul, South Korea
RECRUITINGYeouido St.Mary Hospital
Seoul, South Korea
RECRUITINGMajor Adverse Cardiovascular Events (MACE)
A composite of cardiovascular death, major coronary events (non-fatal MI, documented unstable angina requiring hospital admission, all coronary revascularization with either PCI or bypass surgery occurring at least 30 days after randomization), or non-fatal stroke.
Time frame: 24 months
death from any cause, a major coronary event, or a non-fatal stroke
death from any cause, a major coronary event, or a non-fatal stroke
Time frame: 24 months
cardiovascular death, non-fatal MI, or non-fatal stroke
cardiovascular death, non-fatal MI, or non-fatal stroke
Time frame: 24 months
all-cause death from any cause
Time frame: 24months
cardiovascular death
Time frame: 24months
any myocardial infaction
Time frame: 24 months
any stroke
Time frame: 24 months
any revascularization occurring at least 30 days after randomization
Time frame: 24 months
LDL-C reduction <= 70mg/dl
LDL cholesterol level of 70mg/dL or less
Time frame: 3 months
LDL-C reduction <= 55mg/dl
Time frame: 3 months
Rate of Statin associated muscle symptoms
Stain Associated Muscle Symptom questionnaire
Time frame: 3 months
drug discontinuation or dose reduction
Time frame: 24 months
pill count drug adherence
Time frame: 24 months
new onset diabetes
Time frame: 24 months
cataract
Time frame: 24 months
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