Abstract: Objective To investigate the efficacy and safety of 50 mg enteric sustained-release aspirin tablet in secondary prevention of mild ischemic stroke/TIA. Methods This was a multicenter, randomized, open, parallel control, non-inferior and prospective

clinical study, which enrolled mild ischemic stroke/TIA patients with onset of 21days to 90 days

from 21 domestic centers. All the patients were randomly divided into observation group (Aspirin enteric-coated sustained release tablet 50 mg once every night) and control group (enteric-coated Aspirin 100 mg once every night). Both groups were treated and followed up for 52 weeks. The recurrence of stroke (ischemic stroke, hemorrhagic stroke and TIA), major adverse cardiovascular events (MACE), all-cause death and adverse events were compared between the two groups. Results A total of 567 patients were enrolled in the study, including 287 patients in observation group and 280 patients in control group. The difference in recurrence rate of stroke and/or TIA (4.53% vs 4.29%, P =0.8454), the incidence of MACE (1.05% vs 1.07%, P =1.0000) and all-cause death (0 vs 0.36%, P =0.4938) between the two groups had no statistical significance. The difference in recurrence rate of stroke and/or TIA between the two groups was -0.0011 (95%CI -0.0300-0.0278) in noninferior test. The difference in incidence of bleeding events between the two group had no statistical significance (observation vs control: 2.09% vs 3.21%, P =0.4045), and one case of gastric ulcer bleeding occurred in the control group. The difference in severe adverse events between the two group also had no statistical significance (observation vs control: 0 vs 0.71%, P =0.2434), including 1 case of fracture and 1 case of death after recurrent stroke both in the control group. Conclusions 50 mg enteric sustained-release aspirin tablets are effective in secondary prevention of mild ischemic stroke/TIA, and the incidence and degree of adverse events are relatively mild. The overall efficacy of secondary prevention of stroke/TIA of 50 mg enteric sustained-release aspirin tablets is not inferior to that of 100 mg aspirin enteric-coated tablets.

Key words: Aspirin; Mild ischemic stroke; Transient ischemic attack; Safety; Efficacy

摘要： 目的 研究50 mg阿司匹林肠溶缓释片在轻型缺血性卒中和TIA二级预防中的有效性及安全性。 方法 通过前瞻性、多中心、随机、开放、平行对照、非劣效性设计的临床研究，在国内21个中心入 组发病21～90 d的轻型缺血性卒中和TIA患者，随机分为试验组（每晚口服阿司匹林肠溶缓释片50 mg） 和对照组（每晚口服阿司匹林肠溶片100 mg），服药及随访共52周。比较两组的卒中复发率（包括出 血性卒中、缺血性卒中和TIA）、主要负性心脏事件（major adverse cardiovascular events，MACE）发生率、 全因死亡率和不良事件发生率。 结果 研究共入组567例患者，试验组287例，对照组280例。试验组与对照组的卒中复发率（4.53% vs 4.29%，P =0.8454），MACE发生率（1.05% vs 1.07%，P =1.0000）及全因死亡率（0 vs 0.36%， P =0.4938）差异均无统计学意义。非劣效检验中，试验组与对照组比较卒中和（或）TIA复发率差值 为-0.0011，95%CI为-0.0300～0.0278。试验组与对照组比较出血不良事件发生率差异无统计学意义 （2.09% vs 3.21%，P =0.4045），其中1例胃溃疡出血发生在对照组；试验组与对照组比较严重不良事 件发生率差异无统计学意义（0. vs 0.71%，P =0.2434)，严重不良事件包括骨折1例，卒中复发后死亡1 例，均发生在对照组。 结论 每日口服50 mg阿司匹林肠溶缓释片在轻型缺血性卒中和TIA二级预防中有效，不良事件发生 率及程度有相对较轻的倾向，预防卒中复发的效果不劣于每日口服100 mg阿司匹林肠溶片。

关键词: 阿司匹林; 轻型缺血性卒中; 短暂性脑缺血发作; 安全性; 有效性