3 Months Versus 12 Months Dual Antiplatelet Therapy After Drug-eluting Stent Implantation in STEMI

Study Overview
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Brief Summary
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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.

Detailed Description
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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.

Official Title
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3 Months Versus 12 Months Dual Antiplatelet Therapy After Second Generation Sirolimus Stent Implantation in ST-elevation Myocardial Infarction(BULK-STEMI)

Conditions
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ST Elevation Myocardial Infarction

Intervention / Treatment
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* Drug: ticagrelor monotherapy
* Drug: Aspirin with P2Y12 receptor inhibitor


Participation Criteria
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Eligibility Criteria
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Inclusion Criteria: Patients ≥ 19 years old Patients who received new generation sirolimus-eluting (Osiro®) stent implantation for treating ACS Provision of informed consent Exclusion Criteria: Age > 80 years Pregnant women or women with potential childbearing Life expectancy < 1 year

Ages Eligible for Study
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Minimum Age: 19 Years
Maximum Age: 79 Years

Sexes Eligible for Study
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All

Accepts Healthy Volunteers
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No

Study Plan
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How is the study designed?
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Design Details

Primary Purpose: Treatment
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: None (Open Label)


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Experimental: Ticagrelor monotherapy<br>Ticagrelor monotherapy after 3-month DAPT(aspirin with ticagrelor) | Drug: ticagrelor monotherapy<br>* • Drug: ticagrelor monothearpy after first 3 months dual therapy<br>* Other names: Study group;|
| Active Comparator: Aspirin with P2Y12 receptor inhibitor<br>Aspirin with P2Y12 receptor inhibitor after 3-month DAPT(aspirin with ticagrelor) | Drug: ticagrelor monotherapy<br>* • Drug: ticagrelor monothearpy after first 3 months dual therapy<br>* Other names: Study group;Drug: Aspirin with P2Y12 receptor inhibitor<br>* • Drug: aspirin plus ticagrelor dual therapy during 12 months<br>* Other names: Control group;|

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| NACE: net clinical adverse event | The sum of major adverse cardiac and cerebrovaascular event(MACCE) and bleeding event(BARC score) | 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 | 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 | 12 months after randomization | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Individual component of MACCE and bleeding episode | All-cause mortality :Individual component of MACCE Acute MI :Individual component of MACCE Cerebrovascular event :Individual component of MACCE Stent thrombosis :Definite or probable stent thrombosis defined by Academic Research Consortium (ARC) Bleeding :Bleeding Academic Research Consortium (BARC) type 3 or 5 | 12 months after randomization |