Tenecteplase Reperfusion Therapy in Acute Ischaemic Cerebrovascular Events-5

Summary

The trial is a multicentre, prospective, open-label, blinded endpoint (PROBE), phase 3, randomized controlled design. Patients with acute ischemic stroke due to basilar artery occlusion presenting within 24 hours will be randomized 1:1 to intravenous tenecteplase (0.25mg/kg, maximum 25mg) ± thrombectomy or 'best practice'which may be alteplase (0.9mg/kg) within 4.5 hours from stroke onset or standard care (no lysis) ± thrombectomy at treating clinician's discretion.

Timeline

Start

2024-01-24

Primary completion

2025-09-11

Completion

2025-09-22

Outcome

Met primary endpoint

paper 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). PMID 41655588 ↗

Publications

• Xiong Y, Alemseged F, Cao Z, Schwamm LH, Zhang S, Parsons MW, Fisher M, Hao Y, Jin A, Yin J, Jiang Y, Che F, Wang L, Zhou L, Dai H, Zhao Y, Duan C, Wu S, Feng G, Zong L, Ye W, Wang Z, Xu Z, Wang H, Hao M, Ma Y, Meng X, Li H, Li Z, Wang Y, Liu L, Zhao X, Campbell BCV, Wang Y; TRACE-5 investigators. 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. Lancet. 2026 Feb 21;407(10530):763-772. doi: 10.1016/S0140-6736(25)02633-9. Epub 2026 Feb 5.
• Xiong Y, Alemseged F, Cao Z, Schwamm LH, Parsons M, Fisher M, Wu S, Campbell BCV, Wang Y. Tenecteplase versus standard care in patients with acute basilar artery occlusion: a multi-centre, prospective, randomised, open-label, blinded endpoint, phase 3, controlled trial. Stroke Vasc Neurol. 2025 Oct 28:svn-2025-004432. doi: 10.1136/svn-2025-004432. Online ahead of print.

Drugs

Indications