Endovascular Treatment With or Without Preceding Intravenous Tenecteplase (TNK) in Patients With Late-window acUte Ischemic Stroke Due to Middle Cerebral Artery Occlusion

Phase 3 Completed 391 enrolled Beijing Tiantan Hospital Linyi People's Hospital · collab

RandomizedParallel-groupSingle-blindTreatment

Summary

The purpose of this study is to investigate the safety and efficacy of endovascular treatment with or without preceding intravenous Tenecteplase in patients with late-window (4.5-24 hours of symptom onset) acute ischemic stroke due to middle cerebral artery (MCA) M1 or proximal M2 occlusion.

Timeline

Start: 2024-01-25
Primary completion: 2025-10-13
Completion: 2025-10-13

Outcome

Missed primary endpoint

paper intravenous tenecteplase before EVT did not improve clinical outcomes vs EVT alone. PMID 42099212 ↗

paper adjusted relative rate, 1.01 [95% CI, 0.83-1.24]; P = .89 PMID 42099212 ↗

Publications

Xiong Y, Che F, Wang H, Hao M, Nguyen TN, Fisher M, Jin A, Cao Z, Wang Z, Yao X, Feng G, Xu Y, Guo S, Qin H, Huang X, Xu J, Chen Z, Yuan J, Li W, Hu W, Feng X, Zong L, Ye W, Duan C, Wang L, Wu S, Campbell BCV, Wang Y; TNK-PLUS Investigators. Intravenous Tenecteplase Prior to Endovascular Treatment for Ischemic Stroke at 4.5 to 24 Hours: The TNK-PLUS Randomized Clinical Trial. JAMA. 2026 Jun 2;335(21):1849-1858. doi: 10.1001/jama.2026.4292.

Drugs

Evaluation	Drug	Modality	Dose	Route
Subject	Tenecteplase	Protein / enzyme biologic	0.25 mg/kg	Intravenous