The purpose of this study is to determine whether high dose statin therapy in patients with aspirin mono antiplatelet therapy who had received drug-eluting stent (DES) previously and were free of the adverse cardiac events during the first 12 months could be superior over pravastatin therapy in the prevention of late adverse cardiac and cerebrovascular events during the additional 12 months. Study Design.
Objective: To determine whether high dose statin therapy in patients with aspirin mono antiplatelet therapy who had received drug-eluting stent (DES) previously and were free of the adverse cardiac events during the first 12 months could be superior over pravastatin therapy in the prevention of late adverse cardiac and cerebrovascular events during the additional 12 months. Study Design * Prospective, randomized, multi-center study of each 1000 subjects enrolled. * Eligible subjects will be randomized 1:1 to a) atorvastatin 40 mg (n=1000) vs. b) pravastatin 20 mg/day (n=1000). All subjects will be followed for 1 year after randomization. Additional long-term follow-up (2- or 3-year) will be preceded in the next plan after 1-year study period. * Subjects with coronary artery diseases who meet all inclusion and exclusion criteria will be included Clinical and laboratory follow-up should be performed.
Study Type
INTERVENTIONAL
Allocation
RANDOMIZED
Purpose
TREATMENT
Masking
SINGLE
Enrollment
2,000
Patients will be randomly assigned to the type of statins. Randomization of statin therapy will be done 1:1 to one of two different statins on the web-based program * Atorvastatin 40 mg daily for 12 months after randomization
Patients will be randomly assigned to the type of statins. Randomization of statin therapy will be done 1:1 to one of two different statins on the web-based program Pravastatin 20mg daily for 12 months after randomization
Hong Myeong-Ki
Seoul, South Korea
RECRUITINGthe composite of death from any cause
Occurrence of the composite of death from any cause, MI, target vessel revascularization (TVR, either by PCI or CABG), non-TVR, stent thrombosis (ST), peripheral artery intervention, deterioration of renal function, stroke or admission for significant clinical cardiac events for 12 months following the randomization to the assigned statin therapy.
Time frame: 12 months after randomization
cardiac or non-cardiac death
1. Major determinant for the occurrence of major events(death,MI,TVR,ST) 2. Comparisons of the occurrence of major events according to the attainment of recommended LDL-C goal on current lipid guideline 3. Association between laboratory test and clinical outcomes; 4. Sub-study according to the subsets of disease 5. Association between parameters at index procedure and clinical outcomes
Time frame: 12month
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