3 Months Versus 12 Months Dual Antiplatelet Therapy After Second Generation Sirolimus Stent Implantation in ST-elevation Myocardial Infarction(BULK-STEMI)
试验速览
- 阶段
- 4 期
- 入组人数
- 1,002
- 试验地点
- 1
- 主要终点
- NACE: net clinical adverse event
研究概览
简要总结
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.
详细描述
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.
研究设计
- 研究类型
- Interventional
- 分配方式
- Randomized
- 干预模型
- Parallel
- 主要目的
- Treatment
- 盲法
- None
入排标准
- 年龄范围
- 19 Years 至 79 Years（Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •Patients ≥ 19 years old
- •Patients who received new generation sirolimus-eluting (Osiro®) stent implantation for treating ACS
- •Provision of informed consent
排除标准
- •Age > 80 years
- •Pregnant women or women with potential childbearing
- •Life expectancy < 1 year
研究组 & 干预措施
Ticagrelor monotherapy
Ticagrelor monotherapy after 3-month DAPT(aspirin with ticagrelor)
干预措施: ticagrelor monotherapy (Drug)
Aspirin with P2Y12 receptor inhibitor
Aspirin with P2Y12 receptor inhibitor after 3-month DAPT(aspirin with ticagrelor)
干预措施: ticagrelor monotherapy (Drug)
Aspirin with P2Y12 receptor inhibitor
Aspirin with P2Y12 receptor inhibitor after 3-month DAPT(aspirin with ticagrelor)
干预措施: Aspirin with P2Y12 receptor inhibitor (Drug)
结局指标
主要结局
NACE: net clinical adverse event
时间窗: 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)
时间窗: 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)
时间窗: 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
次要结局
- Individual component of MACCE and bleeding episode(12 months after randomization)
研究者
Kyungil Park
Associate professor
Dong-A University