Less Bleeding by Omitting Aspirin in Non-ST-segment Elevation Acute Coronary Syndrome Patients (LEGACY)

<b>Rationale: </b>Dual antiplatelet therapy, consisting of aspirin and a P2Y12-inhibitor, reduces the risk of stent thrombosis, myocardial infarction and stroke after coronary stent implantation. Inevitably, it is also associated with a higher risk of (major) bleeding. Given the advances in stent properties, stenting implantation technique and pharmacology, it may be possible to treat patients with a single antiplatelet strategy by completely omitting aspirin. <b><br></b><b>Objective: </b>This study will assess whether omitting aspirin reduces the rate of major or minor bleeding while remaining non-inferior to the current standard of care with regards to ischemic events in patients with non-ST segment elevation acute coronary syndrome. <br><b>Study design: </b>Open-label, multicentre randomized controlled trial. <br><br><b>Study population:</b> Adult patients presenting with non-ST segment elevation acute coronary syndrome undergoing percutaneous coronary intervention. <br><br><b>Intervention:</b> In the intervention group aspirin will be completely omitted from the antiplatelet regimen in the 12 months following PCI. <br><br><b>Main study endpoints: </b>The primary bleeding endpoint is major or minor bleeding defined as Bleeding Academic Research Consortium type 2, 3 or 5 bleeding at 12 months. The primary ischemic endpoint is ischemic events defined as the composite of all-cause death, myocardial infarction and stroke at 12 months. <br><br>

<b>研究背景：</b>双联抗血小板治疗（dual antiplatelet therapy）由阿司匹林与P2Y12抑制剂（P2Y12-inhibitor）组成，可降低冠状动脉支架植入术（coronary stent implantation）后支架血栓形成、心肌梗死与卒中的发生风险。但不可避免的是，该治疗方案同时会升高（大出血）风险。鉴于支架性能、支架植入技术与药理学的进展，如今或可通过完全停用阿司匹林，为患者采用单药抗血小板治疗方案。<br><b>研究目的：</b>本研究旨在评估在非ST段抬高型急性冠状动脉综合征（non-ST segment elevation acute coronary syndrome）患者中，停用阿司匹林是否能降低大出血或轻微出血的发生率，同时在缺血事件方面不劣于当前标准治疗方案。<br><b>研究设计：</b>开放标签、多中心随机对照试验。<br><br><b>研究人群：</b>接受经皮冠状动脉介入治疗（percutaneous coronary intervention, PCI）的非ST段抬高型急性冠状动脉综合征成年患者。<br><br><b>干预措施：</b>干预组患者在经皮冠状动脉介入治疗后的12个月内，抗血小板治疗方案中将完全停用阿司匹林。<br><br><b>主要研究终点：</b>主要出血终点为12个月时的大出血或轻微出血，定义为出血学术研究联合会（Bleeding Academic Research Consortium）2、3或5型出血。主要缺血终点为12个月时的缺血事件，定义为全因死亡、心肌梗死与卒中的复合终点。