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Completed

NCT Number: NCT04516993

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

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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Key information

Conditions

Stroke Brain Diseases Cardiovascular Diseases Central Nervous System Diseases Cerebrovascular Disorders Ischemic Stroke Nervous System Diseases Vascular Diseases

Age range

18 year–80 year

Sex eligibility

All sexes

Study type

Interventional

Phase

Phase 2

Primary location

Huashan Hospital

Shanghai, Shanghai Municipality, 200040, China

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

Inclusion criteria

  • 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.

Exclusion criteria

  • 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)
  • Significant head trauma or prior stroke in previous 3 months
  • History of previous intracranial hemorrhage, intracranial neoplasm, arteriovenous malformation, or aneurysm. Risks were considered by the investigator
  • Hereditary or acquired haemorrhagic diathesis
  • Active internal bleeding
  • Symptoms suggestive or recent acute pancreatitis, active gastrointestinal ulcer
  • Severe liver disease, including liver failure, cirrhosis, portal hypertension and active hepatitis
  • Pregnancy or lactation
  • Various dying diseases with life expectancy ≤3 months
  • Other conditions in which doctors believe that participating in this study may be harmful to the patient
  • Patients participated in any trial in 30 days
  • Allergic to the test drug and its ingredients

Treatment and study plan

Tenecteplase

Drug

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)

Drug

Best treatment arm

Primary outcomes

  1. patients without endovascular therapy obtained >50% reperfusion at 4-6 hours

    Time frame: 4-6 hours

    Without endovascular therapy: >50% reperfusion on computed tomography perfusion (CTP) at 4-6 hours

  2. patients with endovascular therapy: mTICI score 2b or better at initial angiogram

    Time frame: Before endovascular therapy

    With endovascular therapy: mTICI score 2b or better at initial angiogram after thrombolysis before endovascular therapy

  3. no symptomatic intracranial hemorrhage at 24-36 hours

    Time frame: 24-36 hours

    No symptomatic intracranial hemorrhage at 24-36 hours

Secondary outcomes

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

    Time frame: 4-6 hours

    Recanalization rate on CTA/MRA at 4-6 hours

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

    Time frame: 3-5 days

    Infarct volume growth (ml) at 3-5 days on MRI or CT perfusion

  3. Clinical efficacy outcome: NIHSS change

    Time frame: 24 hours (plus or minus 2 hours)

    NIHSS change at 24 hours (plus or minus 2 hours)

  4. Clinical efficacy outcome: percent of excellent functional outcome (modified Rankin scale 0-1) at 90 days (plus or minus 7 days)

    Time frame: 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)

  5. Clinical efficacy outcome: percent of good functional outcome (modified Rankin scale 0-2) at 90 days (plus or minus 7 days)

    Time frame: 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)

  6. Clinical efficacy outcome: incident event

    Time frame: 90 days (plus or minus 7 days)

    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))

  7. Imaging safety outcome: Intracranial hemorrhage of any volume at 24-36 hours

    Time frame: 24-36 hours

    Intracranial hemorrhage of any volume at 24-36 hours

  8. Imaging safety outcome: parenchymal hematoma 2 at 24-36 hours

    Time frame: 24-36 hours

    Parenchymal hematoma 2 at 24-36 hours

  9. Imaging safety outcome: Symptomatic intracranial hemorrhage at 24-36 hours

    Time frame: 24-36 hours

    Symptomatic intracranial hemorrhage at 24-36 hours

  10. Clinical safety outcome: death within 90 days

    Time frame: 90 days (plus or minus 7 days)

    Death within 90 days (plus or minus 7 days)

  11. Clinical safety outcome: Rate of systemic bleeding

    Time frame: 90 days (plus or minus 7 days)

    Rate of systemic bleeding within 90 days (plus or minus 7 days)

  12. Barthel index

    Time frame: 90 days (plus or minus 7 days)

    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.

  13. Imaging efficacy outcome: patients without endovascular therapy obtained >50% reperfusion at 4-6 hours

    Time frame: 4-6 hours

    Without endovascular therapy: >50% reperfusion on computed tomography perfusion (CTP) at 4-6 hours without Parenchymal hematoma 2

  14. Imaging efficacy outcome: patients with endovascular therapy: mTICI score 2b or better at initial angiogram

    Time frame: Before endovascular therapy

    With endovascular therapy: mTICI score 2b or better at initial angiogram after thrombolysis before endovascular therapy Parenchymal hematoma 2

  15. Imaging efficacy outcome: recanalization rate on CT/magnetic resonance angiography at 3-5 days

    Time frame: 3-5 days

    Recanalization rate on CTA/MRA at 3-5 days

  16. Clinical efficacy outcome: NIHSS change at 7 days

    Time frame: 7 days (plus or minus 2 days)

    NIHSS change at 7 days (plus or minus 2 days)

  17. Clinical efficacy outcome: vascular death within 90 days

    Time frame: 90 days (plus or minus 7 days)

    Vascular death within 90 days (plus or minus 7 days) (stroke, cardiac infarct, pulmonary embolism)

  18. 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)

    Time frame: 24-36 hours

    Major neurological improvement at 24-36 hours ( NIHSS reduction >8 or return to 0-1)

Sponsors and collaborators

Lead sponsor

Huashan Hospital

Other

Collaborators

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

Registry information

Official study title

Prospective, Multicenter, Open, End-point Blinded, Stratified Block Randomized, Parallel Positive Controlled Clinical Trial of Tenecteplase in Acute Ischemic Stroke With Large Vessel Occlusion Over Time Window

Acronym: CHABLIS-T II

Important dates

Study start
2021
Primary completion
2023
Study completion
2023
First posted
Aug 18, 2020
Registry last updated
Nov 29, 2023

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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