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.

作者：Yunyun Xiong, F. Alemseged, Zhixin Cao, Lee H. Schwamm, Si Zhang, M. Parsons, Marc Fisher, Ya-Hui Hao, A. Jin, Jin-Feng Yin, Yong Jiang, Feng-Yuan Che, Li-Hua Wang, Li Zhou, Hong-Guo Dai, Yutie Zhao, C. Duan, Shuangzhe Wu, Gang-Hua Feng, Lixia Zong, Wanxing Ye, Ziran Wang, Zi-Qi Xu, Hao Wang, M. Hao, Yujie Ma, Xia Meng, Hao Li, Zi-Xiao Li, Yilong Wang, Liping Liu, Xing-Fu Zhao, B. Campbell, Yong-Jun Wang · 发表于：The Lancet · 年份：2026 · DOI：10.1016/s0140-6736(25)02633-9 · 被引用次数：5 · 研究领域：Medicine

BACKGROUND The efficacy and safety of intravenous thrombolysis with tenecteplase within 24 h after stroke onset due to basilar artery occlusion are not well studied. 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. METHODS TRACE-5 was a prospective, randomised, open-label, blinded-endpoint, superiority, phase 3 trial conducted at 66 stroke centres in China. 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). 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. 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. Safety outcomes were symptomatic intracranial haemorrhage and death. The primary outcome and safety outcomes were assesse...