Asundexian for Secondary Stroke Prevention.

Low factor XI levels are associated with a reduced risk of ischemic stroke.

低因子XI水平与缺血性卒中风险降低相关。

Asundexian inhibits activated factor XI.

Asundexian 抑制活化的凝血因子XI。

Whether the addition of asundexian to antiplatelet therapy would be superior to antiplatelet therapy alone for the secondary prevention of ischemic stroke is unclear.

目前尚不清楚将 asundexian 添加到抗血小板治疗中是否比单独使用抗血小板治疗在缺血性中风的二级预防中更为优越。

Methods

In this phase 3, double-blindtrial, we randomly assigned patients within 72 hours after the onset of a noncardioembolic ischemic stroke or high-risk TIA to receive asundexian (50 mg once daily) or placebo, in addition to planned dual or single antiplatelet therapy.

在这项 III 期、双盲试验中，我们在非心源性缺血性中风或高风险短暂性脑缺血发作发病后72小时内，随机分配患者接受阿松德沙星（每日一次50毫克）或安慰剂治疗，同时接受计划中的双重或单一抗血小板治疗。

Patients had at least one of the following: a nonlacunar infarct on imaging, a history of atherosclerosis, or evidence of atherosclerotic plaque at any location on cerebrovascular imaging.

患者至少具有以下一种情况：影像学上非腔隙性梗死，动脉粥样硬化病史，或在任何部位的脑血管成像上动脉粥样硬化斑块的证据。

The primary efficacy outcome was ischemic stroke.

主要疗效终点是缺血性中风。

The composite of death from cardiovascular causes, myocardial infarction, or stroke was a key secondary outcome.

心血管原因死亡、心肌梗死或中风的复合终点是关键次要终点。

The primary safety outcome was major bleeding.

主要安全性结果是重大出血事件。

Results

Among 12,327 patients who underwent randomization (6162 to the asundexian group and 6165 to the placebo group), the incidenceof ischemic stroke was lower in the asundexian group than in the placebo group (6.2% vs. 8.4%; cause-specific hazard ratio, 0.74; 95% confidence interval[CI], 0.65 to 0.84; P<0.001).

在12,327名接受随机分组的患者中（6162人分入阿松德沙组，6165人分入安慰剂组），阿松德沙组的缺血性中风发生率低于安慰剂组（6.2%对比8.4%；特异性原因风险比为0.74；95%置信区间[CI]为0.65至0.84；P<0.001）。

The incidenceof the composite of death from cardiovascular causes, myocardial infarction, or stroke was lower in the asundexian group than in the placebo group.

阿桑德塞安组因心血管原因死亡、心肌梗死或中风的复合发病率低于安慰剂组。

The incidenceof major bleeding was similar in the asundexian group and the placebo group (1.9% and 1.7%, respectively; cause-specific hazard ratio, 1.10; 95% CI, 0.85 to 1.44).

阿桑德塞安组与安慰剂组的主要出血发生率相似（分别为1.9%和1.7%；原因特异性风险比为1.10；95%置信区间为0.85至1.44）。

The incidenceof adverse events was 69.3% in the asundexian group and 70.1% in the placebo group; the incidenceof serious adverse events was 19.2% and 19.5%, respectively.

在阿松德克松组中，不良事件的发生率为69.3%，而在安慰剂组中为70.1%；严重不良事件的发生率分别为19.2%和19.5%。

Conclusions

Among patients with noncardioembolic ischemic stroke or high-risk TIA treated with antiplatelet therapy, asundexian at a daily dose of 50 mg resulted in lower risks of ischemic stroke and major cardiovascular events than placebo, without a higher risk of major bleeding.

在使用抗血小板治疗的非心源性缺血性中风或高风险短暂性脑缺血发作患者中，每日剂量为50毫克的阿松德克松与安慰剂相比，缺血性中风和主要心血管事件的风险较低，而主要出血风险并未增加。

(Funded by Bayer; OCEANIC-STROKE ClinicalTrials.gov number, NCT05686070.).

(由拜耳资助; OCEANIC-STROKE 临床试验注册号, NCT05686070.)