To compare the clinical outcomes of dual antiplatelet therapy with aspirin and P2Y12 receptor inhibitor vs. ticagrelor monotherapy at 3 months after PCI in patients with ST-elevation myocardial infarction.
The purpose of this study is to compare the use of ticagrelor alone versus P2Y12 receptor inhibitor and aspirin together after PCI among ST-elevation myocardial infarction patients who complete 3-month course of dual antiplatelet therapy. The object of this study is to determine the effectiveness and safety of ticagrelor alone, compared to P2Y12 receptor inhibitor plus aspirin in reducing clinically relevant bleeding and in reducing ischemic adverse events among patients diagnosed with ST-elevation myocardial infarction undergoing PCI with second-generation drug-eluting stent.
Study Type
INTERVENTIONAL
Allocation
RANDOMIZED
Purpose
TREATMENT
Masking
NONE
Enrollment
1,002
• Drug: ticagrelor monothearpy after first 3 months dual therapy
• Drug: aspirin plus ticagrelor dual therapy during 12 months
Department of Internal Medicine,Dong-A University College of Medicine
Busan, South Korea
RECRUITINGNACE: net clinical adverse event
The sum of major adverse cardiac and cerebrovaascular event(MACCE) and bleeding event(BARC score)
Time frame: 12 months after randomization
Major adverse cardiac and cerebrovaascular event(MACCE)
Major adverse cardiac and cerebrovaascular event(MACCE) includes 1)all-cause motality, 2) acute MI, 3)cerebrovascular event, 4)stent thrombosis
Time frame: 12 months after randomization
Major bleeding (BARC type 3,5)
The number of participants with first occurrence of clinically relevant bleeding episode, defined as Bleeding Academic Research Consortium (BARC) Types 3 or 5 bleeding. BARC bleeding types range from 0 (no bleeding) to 5 (fatal bleeding). type 3a: Overt bleeding plus hemoglobin drop of 3 to \< 5 g/dL (provided hemoglobin drop is related to bleed); transfusion with overt bleeding, type 3b: Overt bleeding plus hemoglobin drop \< 5 g/dL (provided hemoglobin drop is related to bleed); cardiac tamponade; bleeding requiring surgical intervention for control; bleeding requiring IV vasoactive agents, type 3c: Intracranial hemorrhage confirmed by autopsy, imaging, or lumbar puncture; intraocular bleed compromising vision, type 5a: Probable fatal bleeding, type 5b: Definite fatal bleeding (overt or autopsy or imaging confirmation in accordance with BARC Definitions
Time frame: 12 months after randomization
Individual component of MACCE and bleeding episode
1. All-cause mortality :Individual component of MACCE 2. Acute MI :Individual component of MACCE 3. Cerebrovascular event :Individual component of MACCE 4. Stent thrombosis :Definite or probable stent thrombosis defined by Academic Research Consortium (ARC) 5. Bleeding :Bleeding Academic Research Consortium (BARC) type 3 or 5
Time frame: 12 months after randomization
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