CHinese Acute Tissue-Based Imaging Selection for Lysis In Stroke -Tenecteplase II
NCT ID: NCT04516993
Last Updated: 2023-11-29
Study Results
The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.
Basic Information
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COMPLETED
PHASE2
224 participants
INTERVENTIONAL
2021-09-28
2023-09-30
Brief Summary
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Detailed Description
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Conditions
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Study Design
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RANDOMIZED
PARALLEL
TREATMENT
SINGLE
Study Groups
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Tenecteplase arm
Tenecteplase
Intravenous (IV) tenecteplase 0.25 mg/kg (single bolus; maximum dose 25 mg)
Best treatment arm (e.g. Aspirin, Recombinant Tissue Plasminogen Activator, Urokinase, Thrombectomy)
The best treatment selected by local doctors
The best treatment selected by local doctors(Aspirin, Recombinant Tissue Plasminogen Activator, Urokinase, Thrombectomy)
Best treatment arm
Interventions
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Tenecteplase
Intravenous (IV) tenecteplase 0.25 mg/kg (single bolus; maximum dose 25 mg)
The best treatment selected by local doctors(Aspirin, Recombinant Tissue Plasminogen Activator, Urokinase, Thrombectomy)
Best treatment arm
Eligibility Criteria
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Inclusion Criteria
2. Time from onset to treatment 4.5h-24h
3. Patient's age is \>= 18 years，\<= 80
4. Pre-stroke mRS score of \<= 2
5. Clinically significant acute neurologic deficit
6. Baseline National Institute of Health stroke scale \>= 6
7. Vessel occlusion or severe stenosis ( ICA, MCA-M1/M2, ACA) on computed tomography angiography (CTA)/MRA
8. Multimodal CT/magnetic resonance imaging: perfusion lesion volume (DT \> 3 s) to infarct core volume ratio (rCBF\<30% or diffusion-weighted imaging lesion) \>1.2, absolute difference \>10 ml, and ischemic core volume \<70ml
9. Informed consent was obtained from patients.
Exclusion Criteria
2. Rapidly improving symptoms (patient with an NIHSS score decrease to \< 4 at randomization)
3. Pre-stroke mRS score of \> 2
4. Contraindication to imaging with CT/magnetic resonance imaging with contrast agents
5. Infarct core \>1/3 middle cerebral artery (MCA) territory
6. Platelet count \< 100x10\^9/L
7. Symptoms were caused by low blood glucose \< 2.7 mmol/l
8. Severe uncontrolled hypertension, i.e. systolic blood pressure \>= 180 mmHg or diastolic blood pressure \>=100 mmHg
9. Current use of warfarin with a prolonged prothrombin time (INR \> 1.7 or prothrombin time \> 15s)
10. Use of low molecular weight heparin within 24 hours
11. Use of non-vitamin K antagonist oral anticoagulants (NOACs) within 48 hours
12. Use of glycoprotein IIb - IIIa inhibitors within 72 hours.
13. Arterial puncture at noncompressible site in previous 7 days
14. Major surgery in previous 14 days which poses risk in the opinion of the investigator
15. Recent gastrointestinal or urinary tract hemorrhage (within previous 21 days)
16. Significant head trauma or prior stroke in previous 3 months
17. History of previous intracranial hemorrhage, intracranial neoplasm, arteriovenous malformation, or aneurysm. Risks were considered by the investigator
18. Hereditary or acquired haemorrhagic diathesis
19. Active internal bleeding
20. Symptoms suggestive or recent acute pancreatitis, active gastrointestinal ulcer
21. Severe liver disease, including liver failure, cirrhosis, portal hypertension and active hepatitis
22. Pregnancy or lactation
23. Various dying diseases with life expectancy ≤3 months
24. Other conditions in which doctors believe that participating in this study may be harmful to the patient
25. Patients participated in any trial in 30 days
26. Allergic to the test drug and its ingredients
18 Years
80 Years
ALL
No
Sponsors
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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
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 Medical University
UNKNOWN
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
Huashan Hospital
OTHER
Responsible Party
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Qiang Dong
Director of Neurology Department
Locations
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Huashan Hospital
Shanghai, Shanghai Municipality, China
Countries
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References
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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.
Other Identifiers
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SHDC2020CR1041B
Identifier Type: -
Identifier Source: org_study_id