drugset / Trial / NCT04516993
CHinese Acute Tissue-Based Imaging Selection for Lysis In Stroke -Tenecteplase II
Phase 2
Completed
224 enrolled
Huashan Hospital
Affiliated Haian People's Hospital of Nantong University · collabFirst Affiliated Hospital of Harbin Medical University · collabFudan University · collabHexigten Traditional Chinese and Mongolian Medicine Hospital · collabHuizhou Municipal Central Hospital · collabLinyi People's Hospital · collabNanshi Hospital of Nanyang · collabNingbo No. 1 Hospital · collabPuer People's Hospital · collabSeventh People's Hospital of Shanghai University of Traditional Chinese Medicine · collabShanghai 10th People's Hospital · collabShanghai 6th People's Hospital · collabShanghai East Hospital · collabShuguang Hospital Affiliated to Shanghai University of Traditional Chinese Medicine · collabThe Central Hospital of Jiaozuo Coal Group · collabThe First Affiliated Hospital of Shanxi Medical University · collabThe First Affiliated Hospital of Soochow University · collabThe Second Affiliated Hospital of Chongqing Medical University · collabXuzhou Medical University Affiliated Hospital of Huaian · collabYangpu Hospital, School of Medicine, Tongji University · collabZhejiang Province People's Hospital · collabZhejiang University · collabthe Third Hospital of Mianyang · collab
RandomizedParallel-groupSingle-blindTreatment
Summary
To explore the efficacy and safety of tenecteplase for acute ischemic stroke patients (onset time 4.5-24h) of large vessel occlusion using early combined CT/MR imaging outcomes
Timeline
- Start
- 2021-09-28
- Primary completion
- 2023-09-30
- Completion
- 2023-09-30
Outcome
Met primary endpoint
paper The primary outcome occurred in 33.3% (n=37) of the tenecteplase group versus 10.8% (n=12) in the best medical treatment group (adjusted relative risk, 3.0 [95% CI, 1.6-5.7]; P=0.001). PMID 39744861 ↗
Publications
- Liu X, Hong L, Zhao G, He Z, Wang X, Zhu J, Li S, Zhang A, Cao N, Ling Y, Chen X, Guo Y, Fang Q, Wang Z, Dong Q, Cheng X. Regional perfusion parameters as potential indicators of parenchymal hematoma risk following reperfusion therapy for acute ischemic stroke in the extended time window. Ther Adv Neurol Disord. 2025 Dec 21;18:17562864251406032. doi: 10.1177/17562864251406032. eCollection 2025.
- Hong L, Zhu J, He Z, Wang X, Li S, Liu X, Ling Y, Yang L, Fang Q, Dong Q, Cheng X; CHABLIS-T Investigators. Effect of Time Delay on Reperfusion After Tenecteplase in an Extended Time Window: Analysis From the CHABLIS-T Trials. J Am Heart Assoc. 2025 Jun 17;14(12):e040994. doi: 10.1161/JAHA.124.040994. Epub 2025 Jun 11.
- Cheng X, Hong L, Lin L, Churilov L, Ling Y, Yang N, Fu J, Lu G, Yue Y, Zhang J, Wang F, Wang Z, Zhao Y, Zhou X, Peng Z, Wu D, Zhao L, Zhai Q, Yu X, Fang Q, Shao X, Tang Y, Zhang D, Geng Y, Zhang Y, Fan B, Zhang B, Yin C, Chen Y, Zhang Y, Liu X, Li S, Yang L, Parsons M, Dong Q; CHABLIS-T II Collaborators. Tenecteplase Thrombolysis for Stroke up to 24 Hours After Onset With Perfusion Imaging Selection: The CHABLIS-T II Randomized Clinical Trial. Stroke. 2025 Feb;56(2):344-354. doi: 10.1161/STROKEAHA.124.048375. Epub 2025 Jan 2.
Drugs
| Evaluation | Drug | Modality | Dose | Route |
|---|---|---|---|---|
| Subject | Tenecteplase | Protein / enzyme biologic | 0.25 mg/kg | Intravenous |
| Background | Aspirin | Small molecule | — | — |
| Background | Urokinase | Protein / enzyme biologic | — | — |