Ticagrelor with aspirin dual antiplatelet therapy combined with intravenous thrombolysis in patients with ischaemic stroke in China (TAPIS): a multicentre, double-blind, randomised controlled trial.

We aimed to investigate the efficacy and safety of early oral dual antiplatelet therapy (DAPT), started within 6 h of onset, as an adjunct to intravenous thrombolysis.

我们的目标是研究早期口服双重抗血小板治疗（DAPT），在发病后6小时内开始，作为静脉溶栓治疗的辅助治疗的疗效和安全性。

Methods

TAPIS was a randomised, double-blind, placebo-controlledtrial done in 60 hospitals across China.

TAPIS 是在中国 60 家医院进行的一项随机、双盲、安慰剂对照试验。

We enrolled patients treated with intravenous thrombolysis for ischaemic stroke, with a National Institutes of Health Stroke Scale score of 4-10.

我们招募了接受静脉溶栓治疗的缺血性中风患者，其美国国立卫生研究院卒中量表评分为 4-10 分。

We randomly assigned (1:1) patients to receive oral aspirin plus ticagrelor (DAPT group) or corresponding placebo within 6 h of stroke onset, either before, during, or after receiving thrombolysis.

我们按1:1的比例随机分配患者，在中风发作后6小时内接受口服阿司匹林加替格瑞洛（DAPT组）或相应的安慰剂，无论是接受溶栓治疗之前、期间还是之后。

Ticagrelor or placebo was continued for days 2-7 in each group, with open-label aspirin administered for days 2-90.

在每个组中，替格瑞洛或安慰剂继续使用至第2-7天，而开放标签的阿司匹林则在第2-90天内给药。

Patients, clinicians, and investigators were masked to the group assignment.

患者、临床医生和研究人员对分组分配情况进行了盲法处理。

The primary efficacy outcome was an excellent functional outcome (modified Rankin Scale score 0-1) at 90 days.

主要疗效结果是90天时的优秀功能结果（改良Rankin量表评分0-1分）。

The primary safety outcome was symptomatic intracranial haemorrhage within 36 h.

主要安全性终点是在36小时内发生的症状性颅内出血。

This trial was registered with ClinicalTrials.gov (NCT06316570) and is completed.

该试验已在ClinicalTrials.gov注册（NCT06316570），并已完成。

Results

Between April 3, 2024, and Sept 30, 2025, we randomly assigned 1382 patients to the early DAPT (n=690 [49·9%]) or placebo (n=692 [50·1%]) groups.

2024年4月3日至2025年9月30日期间，我们随机将1382名患者分配到早期双联抗血小板治疗组（n=690，占49.9%）或安慰剂组（n=692，占50.1%）。

The median age was 65·6 years (IQR 58·3-72·0), 991 (71·7%) were men, and 391 (28·3%) were women.

中位年龄为65.6岁（四分位数范围58.3-72.0），991名（71.7%）为男性，391名（28.3%）为女性。

At 90 days, 474 (68·7%) patients in the early DAPT group and 429 (62·0%) in the placebo group achieved excellent functional outcomes (risk ratio 1·11 [95% CI 1·03-1·20; p=0·0089).

在90天时，早期双联抗血小板治疗组有474名（68.7%）患者和安慰剂组有429名（62.0%）患者达到了极佳的功能结果（风险比1.11 [95% 置信区间1.03-1.20; p=0.0089）。

Symptomatic intracranial haemorrhage within 36 h occurred in six (0·9%) patients in the early DAPT group versus five (0·7%) in the control group (risk ratio 1·20 [95% CI 0·37-3·93; p=0.76).

在36小时内，早期双联抗血小板治疗组有六名（0.9%）患者出现症状性颅内出血，而对照组有五名（0.7%）患者出现（风险比1.20 [95% 置信区间0.37-3.93; p=0.76）。

interpretation

Among patients treated with intravenous thrombolysis for moderate ischaemic stroke, initiation of oral DAPT within 6 h of onset improved the likelihood of excellent functional outcomes at 90 days.

在对中度缺血性中风患者进行静脉溶栓治疗的患者中，发病后6小时内开始口服DAPT治疗，提高了90天时极佳功能结果的可能性。

Although no significant between-group difference in symptomatic intracranial haemorrhage was detected, wide CIs precluded exclusion of a small increased risk.

尽管在症状性颅内出血的组间差异上没有检测到显著性，但宽的置信区间排除了小幅度增加风险的可能性。

funding

National Natural Science Foundation of China, Capital's Funds for Health Improvement and Research, Noncommunicable Chronic Diseases-National Science and Technology Major Project, Beijing Municipal Science & Technology Commission, and the New Cornerstone Science Foundation.

中国国家自然科学基金、首都卫生发展科研专项基金、非传染性慢性疾病-国家科技重大专项、北京市科学技术委员会以及新基石科学基金会。