CHinese Acute Tissue-Based Imaging Selection for Lysis In Stroke -Tenecteplase II

NCT04516993 | Completed Phase 2

• 1 other identifier: SHDC2020CR1041B
• Study Type: interventional
• Target: 224
• Locations: 1 country
• Sites: 1

Brief 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

Conditions

Stroke

Keywords

acute ischemic stroke; large vessel occlusion; thrombolysis; tenecteplase; dosage; computed tomography; magnetic resonance imaging; diffusion weighted imaging; early combined imaging outcomes; modified Rankin scale; time window beyond 4.5 hours

Outcome Measures

Primary Outcomes (3)

• 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

Secondary Outcomes (18)

• Imaging efficacy outcome: recanalization rate on CT/magnetic resonance angiography

  4-6 hours

• Imaging efficacy outcome: Infarct volume growth (ml) at 3-5 days on MRI or CT perfusion

  3-5 days

• Clinical efficacy outcome: NIHSS change

  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)

  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)

  90 days (plus or minus 7 days)

Study Arms (2)

Tenecteplase arm

EXPERIMENTAL

Drug: Tenecteplase

Best treatment arm (e.g. Aspirin, Recombinant Tissue Plasminogen Activator, Urokinase, Thrombectomy)

OTHER

The best treatment selected by local doctors

Drug: The best treatment selected by local doctors(Aspirin, Recombinant Tissue Plasminogen Activator, Urokinase, Thrombectomy)

Interventions

Tenecteplase DRUG

Intravenous (IV) tenecteplase 0.25 mg/kg (single bolus; maximum dose 25 mg)

Tenecteplase arm

The best treatment selected by local doctors(Aspirin, Recombinant Tissue Plasminogen Activator, Urokinase, Thrombectomy) DRUG

Best treatment arm

Best treatment arm (e.g. Aspirin, Recombinant Tissue Plasminogen Activator, Urokinase, Thrombectomy)

Eligibility Criteria

• Age: 18 Years - 80 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• Patients presenting with anterior circulation acute ischaemic stroke
• Time from onset to treatment 4.5h-24h
• Patient's age is \>= 18 years，\<= 80
• Pre-stroke mRS score of \<= 2
• Clinically significant acute neurologic deficit
• Baseline National Institute of Health stroke scale \>= 6
• Vessel occlusion or severe stenosis ( ICA, MCA-M1/M2, ACA) on computed tomography angiography (CTA)/MRA
• 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
• Informed consent was obtained from patients.

You may not qualify if:

• Intracranial hemorrhage or subarachnoid hemorrhage identified by CT or MRI
• Rapidly improving symptoms (patient with an NIHSS score decrease to \< 4 at randomization)
• Pre-stroke mRS score of \> 2
• Contraindication to imaging with CT/magnetic resonance imaging with contrast agents
• Infarct core \>1/3 middle cerebral artery (MCA) territory
• Platelet count \< 100x10\^9/L
• Symptoms were caused by low blood glucose \< 2.7 mmol/l
• Severe uncontrolled hypertension, i.e. systolic blood pressure \>= 180 mmHg or diastolic blood pressure \>=100 mmHg
• Current use of warfarin with a prolonged prothrombin time (INR \> 1.7 or prothrombin time \> 15s)
• Use of low molecular weight heparin within 24 hours
• Use of non-vitamin K antagonist oral anticoagulants (NOACs) within 48 hours
• Use of glycoprotein IIb - IIIa inhibitors within 72 hours.
• Arterial puncture at noncompressible site in previous 7 days
• Major surgery in previous 14 days which poses risk in the opinion of the investigator
• Recent gastrointestinal or urinary tract hemorrhage (within previous 21 days)

Sponsors & Collaborators

• Huashan Hospital: lead
• Puer People's Hospital: collaborator
• Shanghai 6th People's Hospital: collaborator
• Hexigten Traditional Chinese and Mongolian Medicine Hospital: collaborator
• Yangpu Hospital, School of Medicine, Tongji University: collaborator
• The First Affiliated Hospital of Shanxi Medical University: collaborator
• Seventh People's Hospital of Shanghai University of Traditional Chinese Medicine: collaborator
• Linyi People's Hospital: collaborator
• Shanghai 10th People's Hospital: collaborator
• Nanshi Hospital of Nanyang: collaborator
• Fudan University: collaborator
• Xuzhou Medical University Affiliated Hospital of Huaian: collaborator
• Shuguang Hospital Affiliated to Shanghai University of Traditional Chinese Medicine: collaborator
• The First Affiliated Hospital of Soochow Medical University: collaborator
• Affiliated Haian People's Hospital of Nantong University: collaborator
• First Affiliated Hospital of Harbin Medical University: collaborator
• the Third Hospital of Mianyang: collaborator
• Zhejiang Province People's Hospital: collaborator
• Shanghai East Hospital: collaborator
• The Central Hospital of Jiaozuo Coal Group: collaborator
• Huizhou Municipal Central Hospital: collaborator
• Zhejiang University: collaborator
• The Second Affiliated Hospital of Chongqing Medical University: collaborator
• Ningbo No. 1 Hospital: collaborator

Study Sites (1)

Huashan Hospital

Shanghai, Shanghai Municipality, 200040, China

Location

Related Publications (3)

• 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.

  PMID: 41446320 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.

  PMID: 40497495 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.

  PMID: 39744861 DERIVED

MeSH Terms

Conditions

Stroke; Ischemic Stroke

Interventions

Tenecteplase; Tissue Plasminogen Activator; Urokinase-Type Plasminogen Activator; Thrombectomy

Condition Hierarchy (Ancestors)

Cerebrovascular Disorders; Brain Diseases; Central Nervous System Diseases; Nervous System Diseases; Vascular Diseases; Cardiovascular Diseases

Intervention Hierarchy (Ancestors)

Serine Endopeptidases; Endopeptidases; Peptide Hydrolases; Hydrolases; Enzymes; Enzymes and Coenzymes; Serine Proteases; Plasminogen Activators; Blood Coagulation Factors; Blood Proteins; Proteins; Amino Acids, Peptides, and Proteins; Biological Factors; Vascular Surgical Procedures; Cardiovascular Surgical Procedures; Surgical Procedures, Operative

Study Design

• Study Type: interventional
• Phase: phase 2
• Allocation: RANDOMIZED
• Masking: SINGLE
• Who Masked: OUTCOMES ASSESSOR
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Director of Neurology Department

Study Record Dates

• First Submitted: August 14, 2020
• First Posted: August 18, 2020
• Study Start: September 28, 2021
• Primary Completion: September 30, 2023
• Study Completion: September 30, 2023
• Last Updated: November 29, 2023

Record last verified: 2023-11

Locations

CN (1)