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Completed

NCT Number: NCT04086147

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

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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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 and older

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
  • Pre-stroke mRS score of <= 2
  • Clinically significant acute neurologic deficit
  • 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
  • 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 observational trial in 30 days
  • Allergic to the test drug and its ingredients

Treatment and study plan

Low dose tenecteplase

Drug

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

High dose tenecteplase

Drug

Intravenous (IV) tenecteplase 0.32 mg/kg (single bolus; maximum dose 32 mg)

Primary outcomes

  1. Favourable 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

  2. Favourable 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

  3. Favourable outcome: 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

    Time frame: 3-5 days

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

  3. Clinical efficacy outcome: 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)

  4. Clinical efficacy outcome: NIHSS change

    Time frame: 24-36 hours

    NIHSS change at 24-36 hours as a continuous variable

  5. Clinical efficacy outcome: excellent functional outcome (modified Rankin scale 0-1) vs (modified Rankin scale 2-6) at 90 days

    Time frame: 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.

  6. Clinical efficacy outcome: good functional outcome (modified Rankin scale 0-2) vs (modified Rankin scale 3-6) at 90 days

    Time frame: 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.

  7. Clinical efficacy outcome: modified Rankin scale shift

    Time frame: 90 days

    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.

  8. 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

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

    Time frame: 24-36 hours

    Parenchymal hematoma 2 at 24-36 hours

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

    Time frame: 24-36 hours

    Symptomatic intracranial hemorrhage at 24-36 hours

  11. Clinical safety outcome: Poor functional outcome (mRS 5, 6) at 90 days

    Time frame: 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.

  12. Clinical safety outcome: Rate of systemic bleeding

    Time frame: 24 hours

    Rate of systemic bleeding within 24 hours

  13. Barthel index

    Time frame: 90 days

    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.

Sponsors and collaborators

Lead sponsor

Huashan Hospital

Other

Collaborators

  • First People's Hospital of Shenyang
  • Ningbo No. 1 Hospital
  • Pu'er City People's Hospital
  • Shanghai 10th People's Hospital
  • Shanghai 5th People's Hospital
  • Shanghai 6th People's Hospital
  • Shanghai East Hospital
  • ShuGuang Hospital
  • The First Affiliated Hospital of Shanxi Medical University
  • The Second Affiliated Hospital of Chongqing Medical University
  • The Second People's Hospital of Huai'an
  • Zhejiang Province People's Hospital

Registry information

Official study title

Chinese Acute Tissue-based Imaging Selection for Lysis in Stroke: a Prospective, Multicentre, Randomized, Open-label, Rater-blinded, Randomized Trial

Acronym: CHABLIS-T

Important dates

Study start
2019
Primary completion
2021
Study completion
2021
First posted
Sep 11, 2019
Registry last updated
Mar 31, 2022

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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