Background:Dual antiplatelet therapy is commonly used for patients with acute coronary syndrome (ACS). This study aimed to evaluate the safety and efficacy of aspirin and prasugrel at standard dosages in Korean patients using clinical outcome data.

Methods and Results:For this prospective multicenter phase IV post-marketing surveillance (PMS) study, ACS patients from 29 July 2012 to 28 July 2016 were recruited. Patients received aspirin at a dose of 75–150 mg daily and a standard dose of prasugrel. Bleeding events were recorded and summarized to evaluate safety. Data on adverse events (AEs) and composite events such as cardiovascular (CV) death, myocardial infarction (MI), and stroke were recorded and summarized to assess efficacy. Of the 3,283 patients recruited, data from 3,110 and 3,044 patients were included in the safety and efficacy analyses, respectively (median treatment duration, 172 days). The most frequently reported AE was ecchymosis (2.8%). The number of patients with major bleeding was 29/3,110 (0.93%). The discontinuation rate for any reason was 12.6%. The number of cases that ended in CV death, MI, stroke, stent thrombosis, or unplanned coronary revascularization was 26/3,044 (0.85%).

Conclusions:The present results are similar to those observed in clinical trials where administration of low-dose aspirin plus prasugrel was associated with a low rate of major bleeding and CV events.

背景：双重抗血小板治疗常用于急性冠脉综合征（ACS）患者。本研究旨在使用临床结果数据评估标准剂量的阿司匹林和普拉格雷在韩国患者中的安全性和有效性。

方法和结果：对于这项前瞻性多中心 IV 期上市后监测 (PMS) 研究，招募了 2012 年 7 月 29 日至 2016 年 7 月 28 日的 ACS 患者。患者每天服用 75-150 毫克的阿司匹林和标准剂量的普拉格雷。记录和总结出血事件以评估安全性。记录和总结不良事件 (AE) 和复合事件 (例如心血管 (CV) 死亡、心肌梗塞 (MI) 和中风) 的数据以评估疗效。在招募的 3,283 名患者中，分别来自 3,110 和 3,044 名患者的数据被纳入安全性和有效性分析（中位治疗持续时间，172 天）。最常报告的 AE 是瘀斑 (2.8%)。大出血患者的数量为 29/3,110 (0.93%)。任何原因的停药率为 12.6%。以 CV 死亡告终的病例数，

结论：目前的结果与临床试验中观察到的结果相似，在临床试验中，低剂量阿司匹林加普拉格雷与低大出血和心血管事件发生率相关。