ST Elevation Myocardial Infarction
Conditions
Brief summary
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
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.
Interventions
• Drug: ticagrelor monothearpy after first 3 months dual therapy
DRUGAspirin with P2Y12 receptor inhibitor
• Drug: aspirin plus ticagrelor dual therapy during 12 months
Sponsors
Dong-A University
Study design
Allocation
RANDOMIZED
Intervention model
PARALLEL
Primary purpose
TREATMENT
Masking
NONE
Eligibility
Sex/Gender
ALL
Age
19 Years to 79 Years
Healthy volunteers
No
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
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| NACE: net clinical adverse event | 12 months after randomization | The sum of major adverse cardiac and cerebrovaascular event(MACCE) and bleeding event(BARC score) |
| Major adverse cardiac and cerebrovaascular event(MACCE) | 12 months after randomization | Major adverse cardiac and cerebrovaascular event(MACCE) includes 1)all-cause motality, 2) acute MI, 3)cerebrovascular event, 4)stent thrombosis |
| Major bleeding (BARC type 3,5) | 12 months after randomization | 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 |
Secondary
| Measure | Time frame | Description |
|---|---|---|
| Individual component of MACCE and bleeding episode | 12 months after randomization | 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 |
Countries
South Korea
Contacts
Primary ContactKyungil Park, Ph.D
Outcome results
None listed