The purpose of this study is to evaluate the efficacy and safety of 5mg maintenance dose (MD) of prasugrel in patients with acute myocardial infarction (AMI) who underwent percutaneous coronary intervention (PCI) with BiomatrixTM stent.
About 1400 patients derived from Korean patients with acute coronary syndrome (ACS) receiving percutaneous coronary intervention (PCI) with BES(Biolimus-eluting stent, BiomatrixTM) in a routine manner will be enrolled in the investigators trial. These patients will be randomized 1:1 to either prasugrel 5mg once daily MD or clopidogrel 75mg once daily MD after successful PCI with BES . The investigators excluded the patients with age ≥75 years, body weight \<60 kg, or history of TIA (transient ischemic attack) or stroke. Follow-up data will be collected until 1-year after index procedure. Primary efficacy end-point defined as the composite of cardiac death, non-fatal MI, stent thrombosis and ischemic driven target vessel revascularization and safety end-points as BARC (the Bleeding Academic Research Consortium) type ≥ 2 bleeding.
Study Type
INTERVENTIONAL
Allocation
RANDOMIZED
Purpose
TREATMENT
Masking
NONE
Enrollment
1,400
Jung-Me Lee
Pusan, South Korea
RECRUITINGA compoiste of cardiac death, non-fatal myocardiac infarction and stroke
Time frame: within the 1 year after BIOMATRIXTM Stent implantation
All-cause death
Time frame: within the 1 year after BIOMATRIXTM Stent implantation
Cardiac death
Time frame: within the 1 year after BIOMATRIXTM Stent implantation
non-fatal myocardial infarction
Time frame: within the 1 year after BIOMATRIXTM Stent implantation
Stroke
Time frame: within the 1 year after BIOMATRIXTM Stent implantation
Target lesion revascularization
Time frame: within the 1 year after BIOMATRIXTM Stent implantation
stent thrombosis
Time frame: within the 1 year after BIOMATRIXTM Stent implantation
BARC bleeding 2,3,and 5
Time frame: within the 1 year after BIOMATRIXTM Stent implantation
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