Intravenous Thrombolysis With rhTNK-tPA for Acute Non-large Vessel Occlusion in Extended Time Window

Phase 4 Completed 570 enrolled Xuanwu Hospital, Beijing Beijing Hospitals Authority · collab CSPC Mingfule Pharmaceutical (Guangzhou) Co., Ltd. · collab

RandomizedParallel-groupSingle-blindTreatment

Summary

This study is designed to evaluate the efficacy of IV rhTNK-tPA between 4.5 to 24 hours from symptom onset in patients presenting with a non-large vessel occlusion ischemic stroke.

Timeline

Start: 2023-06-02
Primary completion: 2025-10-28
Completion: 2025-10-28

Outcome

Met primary endpoint

paper An excellent functional outcome was observed in 123 of 282 patients (43.6%) in the tenecteplase group and 97 of 284 (34.2%) in the control group PMID 41642827 ↗

paper intravenous tenecteplase administered 4.5 to 24 hours after onset resulted in a greater likelihood of an excellent functional outcome at 90 days than standard care PMID 41642827 ↗

Publications

Ma G, Mo R, Zuo Y, Ma Q, Zhao G, Yao X, Liang J, Zhou L, He Y, Long F, Yuan Z, Liu L, Han G, Tan Y, Ai Z, Cai C, Liu J, Zhang L, Yang H, Yi T, Li L, Fu Y, Zhang Y, Shao X, Yu Z, Wu S, Du Y, Mao L, Guo H, Chen X, Chen Y, Zhao Q, Chi L, Liu Y, Zhang H, Li G, Meng S, Wu Y, Wu J, Jiang Z, Lei S, Gao D, Zhong L, Fiehler J, Wang D, Nguyen TN, Saver JL, Hao J; OPTION Investigators. Tenecteplase for Acute Non-Large Vessel Occlusion 4.5 to 24 Hours After Ischemic Stroke: The OPTION Randomized Clinical Trial. JAMA. 2026 Apr 7;335(13):1137-1147. doi: 10.1001/jama.2026.0210.

Drugs

Evaluation	Drug	Modality	Dose	Route
Subject	Tenecteplase	Protein / enzyme biologic	0.25 mg/kg	Intravenous
Comparator	Aspirin	Small molecule	50 mg	—
Comparator	Aspirin	Small molecule	150 mg	—
Comparator	Aspirin	Small molecule	300 mg	—
Comparator	Clopidogrel	Small molecule	—	—