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| Name | Class |
|---|---|
| The First Affiliated Hospital of Shanxi Medical University | OTHER |
| Ningbo No. 1 Hospital | OTHER |
| Zhejiang Province People's Hospital | UNKNOWN |
| Shanghai 5th People's Hospital |
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To select the best dosage 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 |
|---|---|---|---|
| Low dose tenecteplase | Experimental |
| |
| High dose tenecteplase | Experimental |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| Low dose tenecteplase | Drug | Intravenous (IV) tenecteplase 0.25 mg/kg (single bolus; maximum dose 25 mg) |
|
| Measure | Description | Time Frame |
|---|---|---|
| Favourable 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 | 4-6 hours |
| Favourable 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 | Before endovascular therapy |
| Favourable outcome: 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 |
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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 |
| ID | Term |
|---|---|
| D010959 | Tissue Plasminogen Activator |
| D012697 | Serine Endopeptidases |
| D010450 | Endopeptidases |
| D010447 | Peptide Hydrolases |
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| OTHER |
| Shanghai 10th People's Hospital | OTHER |
| Shanghai 6th People's Hospital | OTHER |
| The Second Affiliated Hospital of Chongqing Medical University | OTHER |
| The Second People's Hospital of Huai'an | OTHER |
| Pu'er City People's Hospital | UNKNOWN |
| ShuGuang Hospital | OTHER |
| Shanghai East Hospital | OTHER |
| First People's Hospital of Shenyang | OTHER |
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| High dose tenecteplase | Drug | Intravenous (IV) tenecteplase 0.32 mg/kg (single bolus; maximum dose 32 mg) |
|
Infarct volume growth (ml) at 3-5 days on MRI
| 3-5 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) | 24-36 hours |
| Clinical efficacy outcome: NIHSS change | NIHSS change at 24-36 hours as a continuous variable | 24-36 hours |
| Clinical efficacy outcome: excellent functional outcome (modified Rankin scale 0-1) vs (modified Rankin scale 2-6) at 90 days | Excellent functional outcome (modified Rankin scale 0-1) vs (modified Rankin scale 2-6) at 90 days. The modified Rankin Scale is a simple 7-point assessment that includes reference to both limitations in activity and changes in lifestyle. 0=No symptoms at all; no limitations and no symptoms. 1=No significant disability despite symptoms; able to carry out all usual duties and activities. 2=Slight disability; unable to carry out all previous activities but able to look after own affairs without assistance. 3=Moderate disability; requiring some help, but able to walk without assistance. 4=Moderately severe disability: unable to walk without assistance, and unable to attend to own bodily needs without assistance. 5=Severe disability: bedridden, incontinent, and requiring constant nursing care and attention. 6=Death. | 90 days |
| Clinical efficacy outcome: good functional outcome (modified Rankin scale 0-2) vs (modified Rankin scale 3-6) at 90 days | Good functional outcome (modified Rankin scale 0-2) vs (modified Rankin scale 3-6) at 90 days. The modified Rankin Scale is a simple 7-point assessment that includes reference to both limitations in activity and changes in lifestyle. 0=No symptoms at all; no limitations and no symptoms. 1=No significant disability despite symptoms; able to carry out all usual duties and activities. 2=Slight disability; unable to carry out all previous activities but able to look after own affairs without assistance. 3=Moderate disability; requiring some help, but able to walk without assistance. 4=Moderately severe disability: unable to walk without assistance, and unable to attend to own bodily needs without assistance. 5=Severe disability: bedridden, incontinent, and requiring constant nursing care and attention. 6=Death. | 90 days |
| Clinical efficacy outcome: modified Rankin scale shift | Modified Rankin scale shift at 90 days. The modified Rankin Scale is a simple 7-point assessment that includes reference to both limitations in activity and changes in lifestyle. 0=No symptoms at all; no limitations and no symptoms. 1=No significant disability despite symptoms; able to carry out all usual duties and activities. 2=Slight disability; unable to carry out all previous activities but able to look after own affairs without assistance. 3=Moderate disability; requiring some help, but able to walk without assistance. 4=Moderately severe disability: unable to walk without assistance, and unable to attend to own bodily needs without assistance. 5=Severe disability: bedridden, incontinent, and requiring constant nursing care and attention. 6=Death. | 90 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: Poor functional outcome (mRS 5, 6) at 90 days | Poor functional outcome (mRS 5, 6) at 90 days. The modified Rankin Scale is a simple 7-point assessment that includes reference to both limitations in activity and changes in lifestyle. 0=No symptoms at all; no limitations and no symptoms. 1=No significant disability despite symptoms; able to carry out all usual duties and activities. 2=Slight disability; unable to carry out all previous activities but able to look after own affairs without assistance. 3=Moderate disability; requiring some help, but able to walk without assistance. 4=Moderately severe disability: unable to walk without assistance, and unable to attend to own bodily needs without assistance. 5=Severe disability: bedridden, incontinent, and requiring constant nursing care and attention. 6=Death. | 90 days |
| Clinical safety outcome: Rate of systemic bleeding | Rate of systemic bleeding within 24 hours | 24 hours |
| Barthel index | Barthel index at 90 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 |
| 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. |
| 38286484 | Derived | Cheng X, Hong L, Churilov L, Lin L, Ling Y, Zhang J, Yang J, Geng Y, Wu D, Liu X, Zhou X, Zhao Y, Zhai Q, Zhao L, Chen Y, Guo Y, Yu X, Gong F, Sui Y, Li G, Yang L, Gu HQ, Wang Y, Parsons M, Dong Q; CHABLIS-T collaborators. Tenecteplase thrombolysis for stroke up to 24 hours after onset with perfusion imaging selection: the umbrella phase IIa CHABLIS-T randomised clinical trial. Stroke Vasc Neurol. 2024 Nov 5;9(5):551-559. doi: 10.1136/svn-2023-002820. |
| D014652 | Vascular Diseases |
| D002318 | Cardiovascular Diseases |
| D006867 |
| Hydrolases |
| 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 |