Evaluation of a Modified Anti-Platelet Therapy Associated With Low-dose DES Firehawk in Acute Myocardial Infarction Patients Treated With Complete Revascularization Strategy
试验速览
- 阶段
- 不适用
- 状态
- 已完成
- 发起方
- 入组人数
- 2,248
- 试验地点
- 40
- 主要终点
- Net Adverse Clinical and Cerebral Events (NACCE)
研究概览
简要总结
The study aims to evaluate a modified antiplatelet therapy associated with Firehawk low-dose rapamycin DES in acute myocardial infarction patients treated with complete revascularization strategy. The modified antiplatelet therapy consists of a reduced duration of Dual Antiplatelet Therapy post procedure (ie. 1 month duration) followed by P2Y12 inhibitor monotherapy for the next 11 months. It is hypothesized that in the setting of clinically stable, low to moderate complexity acute Myocardial Infarction patients, a modern approach combining a stent with high biocompatibility feature, complete revascularization strategy and modified antiplatelet therapy may be associated with similar outcomes, or even a significant benefit compared with guidelines-recommended 12-month DAPT. This benefit could be driven by a reduced risk in significant bleeding events, while keeping a comparable protection against ischemic risk. Enrolled subjects will be randomized in a 1:1 ratio to either cessation of aspirin at 1 months, either continuation of DAPT. Selection of the P2Y12 inhibitor agent is left to investigator judgment but has to be in line with the current ESC guidelines. Subjects treated with the Firehawk or Firehawk Liberty coronary stent will be included in this study.
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
- 18 Years 至 —（Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- 未提供
排除标准
- 未提供
研究组 & 干预措施
Shortened DAPT followed by P2Y12 inhibitor monotherapy
干预措施: Shortened DAPT followed by P2Y12 inhibitor monotherapy (cessation of aspirin) (Drug)
Dual Antiplatelet Therapy
干预措施: Standard DAPT (Drug)
结局指标
主要结局
Net Adverse Clinical and Cerebral Events (NACCE)
时间窗: 11 months post randomization
(Number of participants with first occurrence of) NACCE, defined as a composite of all cause death, non-fatal myocardial infarction, definite/probable stent thrombosis, stroke, or bleeding events (BARC type 3 or 5)
次要结局
- Bleeding events(11 months post randomization)
- Main secondary endpoint component 1 - BARC 2 events(At 1 month, 6 months and 12 months)
- Primary endpoint component 3 - Stent thrombosis(At 1 months, 6 months and 12 months)
- Main secondary endpoint component 3 - BARC 5 events(At 1 month, 6 months and 12 months)
- Cardiac death or non-fatal myocardial infarction(At 1 month, 6 months and 12 months)
- Primary endpoint component 1 - All cause death(At 1 month, 6 months and 12 months)
- Primary endpoint component 2 - Myocardial infarction(At 1 month, 6 months and 12 months)
- All-cause death or non-fatal myocardial infarction(At 1 month, 6 months and 12 months)
- Major Adverse Cardiac and Cerebral Events (MACCE) - Patient(At 1 month, 6 months and 12 months)
- Major Adverse Cardiac and Cerebral events (MACE) - Events(At 1 Month, 6 months and 12 months)
- Cardiovascular death(At 1 months, 6 months and 12 months)
- Non cardiac death(At 1 month, 6 months and 12 months)
- Cardiovascular death, myocardial infarction, definite/probable stent thrombosis, or ischemic stroke(1 month, 6 months and 12 months)
- Primary endpoint component 4 - Ischemic stroke(At 1 month, 6 months and 12 months)
- Haemorrhagic stroke(At 1 month, 6 months and 12 months)
- All-cause death, non-fatal myocardial infarction, definite/probable stent thrombosis, or stroke(At 1 month, 6 months and 12 months)
- Target Lesion Failure - Device(At 1 month, 6 months and 12 months)
- Ischemia-driven target lesion revascularization(At 1 month, 6 months and 12 months)
- Cardiovascular death, myocardial infarction, or ischemic stroke(At 1 month, 6 months and 12 months)
- Primary endpoint component 5 - BARC 3 and 5 bleeding events(At 1 month, 6 months and 12 months)
- Main secondary endpoint component 2 - BARC 3 events(At 1 month, 6 months and 12 months)
- Cardiac death(At 1 month, 6 months and 12 months)
- Cardiac death, myocardial infarction, or definite/probable stent thrombosis(At 1 month, 6 months and 12 months)
- Ischemia-driven target vessel revascularization(At 1 month, 6 months and 12 months)