Tenecteplase versus standard medical treatment for basilar artery occlusion within 24 h (TRACE-5): a multicentre, prospective, randomised, open-label, blinded-endpoint, superiority, phase 3 trial.

We aimed to assess whether intravenous tenecteplase administered within 24 h after symptom onset improved functional outcome compared with standard medical treatment in patients with basilar artery occlusion.

我们的目标是评估在症状发作后24小时内给予静脉注射替奈普酶是否能改善基底动脉闭塞患者的临床功能结果，与标准的内科治疗相比。

Methods

TRACE-5 was a prospective, randomised, open-label, blinded-endpoint, superiority, phase 3 trial conducted at 66 stroke centres in China.

TRACE-5 是在中国的 66 个卒中中心进行的一项前瞻性、随机、开放标签、盲终点、优效性、III 期试验。

We included patients aged 18 years or older with stroke due to basilar artery occlusion who were eligible for intravenous thrombolytics within 24 h of stroke onset or the time they were last known to be well and had a pre-stroke modified Rankin scale (mRS) score of 3 or less (scores range from 0 to 6, with higher scores indicating greater disability).

我们纳入了年龄在 18 岁或以上的患者，这些患者因基底动脉闭塞导致的卒中而有资格在卒中发作后或最后一次已知状态良好后 24 小时内接受静脉溶栓治疗，并且在卒中前的改良 Rankin 量表（mRS）评分为 3 或以下（评分范围从 0 到 6，分数越高表示残疾程度越大）。

Patients were randomly assigned to receive a single intravenous bolus of tenecteplase (0·25 mg/kg; maximum 25 mg) within 24 h after symptom onset or standard medical treatment (which could include intravenous alteplase at 0·9 mg/kg, maximum 90 mg, within 4·5 h of symptom onset; anticoagulation; or antiplatelets), with or without endovascular thrombectomy.

患者被随机分配接受单次静脉推注 tenecteplase（0.25 mg/kg；最大剂量25 mg）在症状发作后24小时内，或接受标准的医疗治疗（可能包括在症状发作后4.5小时内静脉推注alteplase 0.9 mg/kg，最大剂量90 mg；抗凝治疗；或抗血小板治疗），可进行或不进行血管内血栓切除术。

The primary outcome was a score of 0-1 on the mRS or return to the baseline mRS score (if the baseline pre-stroke mRS score was 2-3) at 90 days.

主要结果是在90天时，mRS评分为0-1分或恢复到基线mRS评分（如果基线中风前mRS评分为2-3分）。

Safety outcomes were symptomatic intracranial haemorrhage and death.

安全性结果包括症状性颅内出血和死亡。

The primary outcome and safety outcomes were assessed in all randomly assigned participants included in their originally assigned groups.

主要结果和安全性结果在所有随机分配的参与者中进行了评估，这些参与者包括在他们最初分配的组别中。

This trial is registered with ClinicalTrials.gov, NCT06196320.

该试验已在ClinicalTrials.gov注册，注册号为NCT06196320。

Results

Between Jan 24, 2024, and June 20, 2025, 452 patients were enrolled (mean age 66·4 years [SD 11·2], 321 [71%] males, and 131 [29%] females), of whom 222 (49%) subsequently underwent thrombectomy; 221 were randomly assigned to receive tenecteplase and 231 to receive standard medical treatment.

在2024年1月24日至2025年6月20日期间，共有452名患者（平均年龄66.4岁[标准差11.2]，其中321名[71%]为男性，131名[29%]为女性）被纳入研究，其中222名（49%）随后接受了血栓切除术；221名患者被随机分配接受替奈普酶治疗，231名患者接受标准的药物治疗。

Alteplase was used in 80 (35%) of the patients in the standard medical treatment group.

在标准医疗治疗组中，有80名（35%）患者使用了阿替普酶。

An mRS score of 0-1 or return to the baseline mRS score occurred in 83 (38%) patients in the tenecteplase group and 66 (29%) patients in the standard medical treatment group (adjusted relative rate 1·50 [95% CI 1·09-2·08], p=0·014).

在替奈普酶组中，有83名（38%）患者获得了0-1分的mRS评分或恢复至基线mRS评分，而在标准医疗治疗组中，有66名（29%）患者达到此标准（调整后的相对率1·50 [95% 置信区间 1·09-2·08]，p=0·014）。

Symptomatic intracranial haemorrhage within 36 h occurred in four (2%) patients in the tenecteplase group and seven (3%) patients in the standard medical treatment group (adjusted relative rate 0·58 [95% CI 0·17-1·99]).

在36小时内，tenecteplase组有四名（2%）患者出现症状性颅内出血，而标准医疗治疗组有七名（3%）患者出现（调整后的相对率0·58 [95% 置信区间 0·17-1·99]）。

All-cause mortality at 90 days was similar between groups (65 [29%] patients in the tenecteplase group and 71 [31%] patients in the standard medical treatment group; adjusted relative rate 0·87 [95% CI 0·62-1·22]), as was the proportion of patients with an mRS score of 5-6 at 90 days (82 [37%] vs 89 [39%]; 0·87 [0·65-1·18]).

90天全因死亡率在两组之间相似（tenecteplase组有65名（29%）患者，标准医疗治疗组有71名（31%）患者；调整后的相对率0·87 [95% 置信区间 0·62-1·22]），90天时mRS评分为5-6的患者比例也相似（82名（37%）对比89名（39%）；0·87 [0·65-1·18]）。

interpretation

In this trial involving Chinese patients with ischaemic stroke due to basilar artery occlusion, tenecteplase within 24 h after stroke onset improved functional outcome compared with standard medical treatment.

在这项涉及中国缺血性脑卒中患者的试验中，发病后24小时内使用替奈普酶与标准药物治疗相比，改善了功能结果。

The incidenceof symptomatic intracranial haemorrhage and death was similar.

症状性颅内出血和死亡的发生率相似。

funding

Noncommunicable Chronic Diseases-National Science and Technology Major Project, Beijing Municipal Science Fund for Distinguished Young Scholars, National Natural Science Foundation of China, and China Shijiazhuang Pharmaceutical Company Recomgen Pharmaceutical (Guangzhou).

非传染性慢性疾病-国家科技重大专项、北京市杰出青年科学基金、国家自然科学基金和中国石家庄制药公司Recomgen制药（广州）