Myocardial Infarction Clinical Trial
Official title:
A Prospective, Multicenter, Randomized, Open-label Trial to Evaluate Efficacy and Safety of 5mg Maintenance Dose of Prasugrel in Patients With Acute Coronary Syndrome Who Underwent Percutaneous Coronary Intervention With BiomatrixTM Stent
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.
;
Allocation: Randomized, Endpoint Classification: Safety/Efficacy Study, Intervention Model: Parallel Assignment, Masking: Open Label, Primary Purpose: Treatment
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