Teneteplase Reperfusion Therapy in Acute Ischemic Cerebrovascular Events-III

Summary

The trial is a phase 3, multicenter, prospective, randomized, open-label, blinded-endpoint (PROBE) controlled design. Patients with acute ischemic stroke due to anterior circulation large vessel occlusion within 4.5-24 hours from last known well (including wake-up stroke and unwitnessed stroke) will be randomized 1:1 to 0.25mg/kg intravenous tenecteplase or standard medical treatment.

Timeline

Start

2022-01-19

Primary completion

2024-01-29

Completion

2024-02-09

Publications

• Wang H, Cao Z, Campbell BCV, Katsanos AH, Yin J, Fisher M, Wang Y, Xiong Y. Effects of Fibrinogen on Tenecteplase Treatment in Acute Ischaemic Stroke After 4.5 Hours of Symptom Onset: A Post Hoc Analysis of the TRACE-III Trial. Neurol Ther. 2026 May 20. doi: 10.1007/s40120-026-00958-4. Online ahead of print.
• Lu Z, Wang Z, Jin A, Che F, Wang L, Zhou L, Dai H, Liu X, Cao Z, Wang L, Hao M, Ye W, Xiong Y, Wang Y. Clinical benefit of tenecteplase despite failed recanalization in late-window ischemic stroke: a post hoc analysis of the TRACE-3 trial. BMC Med. 2026 Apr 16;24(1):328. doi: 10.1186/s12916-026-04877-x.
• Xiong Y, Campbell BCV, Schwamm LH, Meng X, Jin A, Parsons MW, Fisher M, Jiang Y, Che F, Wang L, Zhou L, Dai H, Liu X, Pan Y, Duan C, Xu Y, Xu A, Zong L, Tan Z, Ye W, Wang H, Wang Z, Hao M, Cao Z, Wang L, Wu S, Li H, Li Z, Zhao X, Wang Y; TRACE-III Investigators. Tenecteplase for Ischemic Stroke at 4.5 to 24 Hours without Thrombectomy. N Engl J Med. 2024 Jul 18;391(3):203-212. doi: 10.1056/NEJMoa2402980. Epub 2024 Jun 14.
• Xiong Y, Campbell BCV, Fisher M, Schwamm LH, Parsons M, Li H, Pan Y, Meng X, Zhao X, Wang Y. Rationale and design of Tenecteplase Reperfusion Therapy in Acute Ischaemic Cerebrovascular Events III (TRACE III): a randomised, phase III, open-label, controlled trial. Stroke Vasc Neurol. 2024 Feb 27;9(1):82-89. doi: 10.1136/svn-2023-002310.

Drugs

Indications