1. Objective : To test the safety of 6 month-duration of dual antiplatelet therapy (DAPT) compared to conventional 12-month-or-longer duration after second-generation drug-eluting stent (DES) implantation in patients with acute coronary syndrome (ACS). 2. Hypothesis : A 6-month duration of DAPT is non-inferior to a conventional 12-month-or longer duration of DAPT at preventing the occurrence of major adverse cardiac and cerebrovascular events (MACCE) at 18-month after second-generation DES implantation in patients with ACS.
1. Primary endpoint \- MACCE, defined as a composite of all-cause mortality, myocardial infarction, and cerebrovascular events at 18 months after the index procedure. 2. Secondary endpoint * Individual components of the primary endpoint at 18-month after the index procedure * Definite/probable stent thrombosis, defined by the Academic Research Consortium (ARC) at 18-month after the index procedure. * Bleeding complication, defined by Bleeding Academic Research Consortium (BARC) type 2 to 5 at 18-month after the index procedure.
Study Type
INTERVENTIONAL
Allocation
RANDOMIZED
Purpose
TREATMENT
Masking
NONE
Enrollment
2,712
P2Y12 inhibitor (clopidogrel, ticagrelor, prasugrel)
Samsung Medical Center
Seoul, South Korea
A composite of all-cause mortality, spontaneous myocardial infarction (MI), and cerebrovascular event
defined as MACCE
Time frame: at 18-month after the index procedure
All-cause mortality
Individual component of MACCE
Time frame: at 18-month after the index procedure
Spontaneous MI
Individual component of MACCE
Time frame: at 18-month after the index procedure
Cerebrovascular event
Individual component of MACCE
Time frame: at 18-month after the index procedure
Stent thrombosis
Definite or probable stent thrombosis defined by Academic Research Consortium (ARC)
Time frame: at 18-month after the index procedure
Bleeding
Bleeding Academic Research Consortium (BARC) type 2 to 5
Time frame: at 18-month after the index procedure
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