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| Name | Class |
|---|---|
| Puer People's Hospital | UNKNOWN |
| Shanghai 6th People's Hospital | OTHER |
| Hexigten Traditional Chinese and Mongolian Medicine Hospital | UNKNOWN |
| Yangpu Hospital, School of Medicine, Tongji University |
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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
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| Tenecteplase arm | Experimental |
| |
| Best treatment arm (e.g. Aspirin, Recombinant Tissue Plasminogen Activator, Urokinase, Thrombectomy) | Other | The best treatment selected by local doctors |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| Tenecteplase | Drug | Intravenous (IV) tenecteplase 0.25 mg/kg (single bolus; maximum dose 25 mg) |
|
| Measure | Description | Time Frame |
|---|---|---|
| patients without endovascular therapy obtained >50% reperfusion at 4-6 hours | Without endovascular therapy: >50% reperfusion on computed tomography perfusion (CTP) at 4-6 hours | 4-6 hours |
| patients with endovascular therapy: mTICI score 2b or better at initial angiogram | With endovascular therapy: mTICI score 2b or better at initial angiogram after thrombolysis before endovascular therapy | Before endovascular therapy |
| no symptomatic intracranial hemorrhage at 24-36 hours | No symptomatic intracranial hemorrhage at 24-36 hours | 24-36 hours |
| Measure | Description | Time Frame |
|---|---|---|
| Imaging efficacy outcome: recanalization rate on CT/magnetic resonance angiography | Recanalization rate on CTA/MRA at 4-6 hours | 4-6 hours |
| Imaging efficacy outcome: Infarct volume growth (ml) at 3-5 days on MRI or CT perfusion |
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Inclusion Criteria:
Exclusion Criteria:
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| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| Huashan Hospital | Shanghai | Shanghai Municipality | 200040 | China |
| PubMed Identifier | Type | Citation | Retractions |
|---|---|---|---|
| 41446320 | Derived | 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. | |
| 40497495 |
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| ID | Term |
|---|---|
| D020521 | Stroke |
| D000083242 | Ischemic Stroke |
| ID | Term |
|---|---|
| D002561 | Cerebrovascular Disorders |
| D001927 | Brain Diseases |
| D002493 | Central Nervous System Diseases |
| D009422 | Nervous System Diseases |
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| ID | Term |
|---|---|
| D000077785 | Tenecteplase |
| D010959 | Tissue Plasminogen Activator |
| D014568 | Urokinase-Type Plasminogen Activator |
| D017131 | Thrombectomy |
| ID | Term |
|---|---|
| D012697 | Serine Endopeptidases |
| D010450 | Endopeptidases |
| D010447 | Peptide Hydrolases |
| D006867 | Hydrolases |
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| UNKNOWN |
| The First Affiliated Hospital of Shanxi Medical University | OTHER |
| Seventh People's Hospital of Shanghai University of Traditional Chinese Medicine | UNKNOWN |
| Linyi People's Hospital | OTHER |
| Shanghai 10th People's Hospital | OTHER |
| Nanshi Hospital of Nanyang | UNKNOWN |
| Fudan University | OTHER |
| Xuzhou Medical University Affiliated Hospital of Huaian | UNKNOWN |
| Shuguang Hospital Affiliated to Shanghai University of Traditional Chinese Medicine | UNKNOWN |
| The First Affiliated Hospital of Soochow University | OTHER |
| Affiliated Haian People's Hospital of Nantong University | UNKNOWN |
| First Affiliated Hospital of Harbin Medical University | OTHER |
| the Third Hospital of Mianyang | UNKNOWN |
| Zhejiang Province People's Hospital | UNKNOWN |
| Shanghai East Hospital | OTHER |
| The Central Hospital of Jiaozuo Coal Group | UNKNOWN |
| Huizhou Municipal Central Hospital | OTHER |
| Zhejiang University | OTHER |
| The Second Affiliated Hospital of Chongqing Medical University | OTHER |
| Ningbo No. 1 Hospital | OTHER |
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| The best treatment selected by local doctors(Aspirin, Recombinant Tissue Plasminogen Activator, Urokinase, Thrombectomy) | Drug | Best treatment arm |
|
Infarct volume growth (ml) at 3-5 days on MRI or CT perfusion
| 3-5 days |
| Clinical efficacy outcome: NIHSS change | NIHSS change at 24 hours (plus or minus 2 hours) | 24 hours (plus or minus 2 hours) |
| Clinical efficacy outcome: percent of excellent functional outcome (modified Rankin scale 0-1) at 90 days (plus or minus 7 days) | percent of excellent functional outcome (modified Rankin scale 0-1) at 90 days (plus or minus 7 days) | 90 days (plus or minus 7 days) |
| Clinical efficacy outcome: percent of good functional outcome (modified Rankin scale 0-2) at 90 days (plus or minus 7 days) | percent of good functional outcome (modified Rankin scale 0-2) at 90 days (plus or minus 7 days) | 90 days (plus or minus 7 days) |
| Clinical efficacy outcome: incident event | Incident vascular event within 90 days (ischemic stroke/ hemorrhagic stroke/ cardiac infarct/ cardiac or brain revascularization (including Carotid Endarterectomy, Intracranial and Extracranial Artery Intervention, Intracranial and extracranial artery bypass, and Coronary artery intervention or bypass graft)) | 90 days (plus or minus 7 days) |
| Imaging safety outcome: Intracranial hemorrhage of any volume at 24-36 hours | Intracranial hemorrhage of any volume at 24-36 hours | 24-36 hours |
| Imaging safety outcome: parenchymal hematoma 2 at 24-36 hours | Parenchymal hematoma 2 at 24-36 hours | 24-36 hours |
| Imaging safety outcome: Symptomatic intracranial hemorrhage at 24-36 hours | Symptomatic intracranial hemorrhage at 24-36 hours | 24-36 hours |
| Clinical safety outcome: death within 90 days | Death within 90 days (plus or minus 7 days) | 90 days (plus or minus 7 days) |
| Clinical safety outcome: Rate of systemic bleeding | Rate of systemic bleeding within 90 days (plus or minus 7 days) | 90 days (plus or minus 7 days) |
| Barthel index | Barthel index at 90 days (plus or minus 7 days). The Barthel Index is a scale that indicates the ability to perform a selection of activities of daily living. It comprises 10 items (tasks), with total scores ranging from 0 (worst mobility in activities of daily living) to 100 (full mobility in activities of daily living) and it has adequate clinimetric (quality of clinical measurements) properties in stroke rehabilitation. In the index, the 10 items have these scoring combinations: a) 0 and 5, b) 0, 5 and 10, or c) 0, 5, 10 and 15. These items in the Barthel Index address a patient's ability in feeding, bathing, grooming, dressing, bowel and bladder control, toileting, chair transfer, ambulation and stair climbing. | 90 days (plus or minus 7 days) |
| Imaging efficacy outcome: patients without endovascular therapy obtained >50% reperfusion at 4-6 hours | Without endovascular therapy: >50% reperfusion on computed tomography perfusion (CTP) at 4-6 hours without Parenchymal hematoma 2 | 4-6 hours |
| Imaging efficacy outcome: patients with endovascular therapy: mTICI score 2b or better at initial angiogram | With endovascular therapy: mTICI score 2b or better at initial angiogram after thrombolysis before endovascular therapy Parenchymal hematoma 2 | Before endovascular therapy |
| Imaging efficacy outcome: recanalization rate on CT/magnetic resonance angiography at 3-5 days | Recanalization rate on CTA/MRA at 3-5 days | 3-5 days |
| Clinical efficacy outcome: NIHSS change at 7 days | NIHSS change at 7 days (plus or minus 2 days) | 7 days (plus or minus 2 days) |
| Clinical efficacy outcome: vascular death within 90 days | Vascular death within 90 days (plus or minus 7 days) (stroke, cardiac infarct, pulmonary embolism) | 90 days (plus or minus 7 days) |
| Clinical efficacy outcome: major neurological improvement at 24-36 hours ( NIHSS reduction ≥8 or return to 0-1)major neurological improvement at 24-36 hours ( NIHSS reduction ≥8 or return to 0-1) | Major neurological improvement at 24-36 hours ( NIHSS reduction >8 or return to 0-1) | 24-36 hours |
| Derived |
| 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. |
| 39744861 | Derived | 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. |
| D014652 | Vascular Diseases |
| D002318 | Cardiovascular Diseases |
| D004798 |
| Enzymes |
| D045762 | Enzymes and Coenzymes |
| D057057 | Serine Proteases |
| D010960 | Plasminogen Activators |
| D001779 | Blood Coagulation Factors |
| D001798 | Blood Proteins |
| D011506 | Proteins |
| D000602 | Amino Acids, Peptides, and Proteins |
| D001685 | Biological Factors |
| D014656 | Vascular Surgical Procedures |
| D013504 | Cardiovascular Surgical Procedures |
| D013514 | Surgical Procedures, Operative |