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CHinese Acute Tissue-Based Imaging Selection for Lysis In Stroke -Tenecteplase (CHABLIS-T)

The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Know the risks and potential benefits of clinical studies and talk to your health care provider before participating. Read our disclaimer for details.
 
ClinicalTrials.gov Identifier: NCT04086147
Recruitment Status : Recruiting
First Posted : September 11, 2019
Last Update Posted : December 17, 2019
Sponsor:
Collaborators:
Shanghai 6th People's Hospital
Shanghai 10th People's Hospital
Shanghai East Hospital
Information provided by (Responsible Party):
Qiang Dong, Huashan Hospital

Brief Summary:
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

Condition or disease Intervention/treatment Phase
Stroke Drug: Low dose tenecteplase Drug: High dose tenecteplase Phase 2

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Study Type : Interventional  (Clinical Trial)
Estimated Enrollment : 86 participants
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Single (Outcomes Assessor)
Primary Purpose: Treatment
Official Title: Chinese Acute Tissue-based Imaging Selection for Lysis in Stroke: a Prospective, Multicentre, Randomized, Open-label, Rater-blinded, Randomized Trial
Actual Study Start Date : December 9, 2019
Estimated Primary Completion Date : December 2020
Estimated Study Completion Date : December 2020

Resource links provided by the National Library of Medicine


Arm Intervention/treatment
Experimental: Low dose tenecteplase Drug: Low dose tenecteplase
Intravenous (IV) tenecteplase 0.25 mg/kg (single bolus; maximum dose 25 mg)

Experimental: High dose tenecteplase Drug: High dose tenecteplase
Intravenous (IV) tenecteplase 0.32 mg/kg (single bolus; maximum dose 32 mg)




Primary Outcome Measures :
  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 Outcome Measures :
  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.



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Ages Eligible for Study:   18 Years and older   (Adult, Older Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No
Criteria

Inclusion Criteria:

  1. Patients presenting with anterior circulation acute ischaemic stroke
  2. Time from onset to treatment 4.5h-24h
  3. Patient's age is ≥18 years
  4. Pre-stroke mRS score of <= 2
  5. Clinically significant acute neurologic deficit
  6. Vessel occlusion or severe stenosis ( ICA, MCA-M1/M2, ACA) on computed tomography angiography (CTA)/MRA
  7. 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
  8. Informed consent was obtained from patients.

Exclusion Criteria:

  1. Intracranial hemorrhage or subarachnoid hemorrhage identified by CT or MRI
  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
  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 observational trial in 30 days
  26. Allergic to the test drug and its ingredients

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT04086147


Contacts
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Contact: Qiang Dong, MD, PhD 86-21-52887142 qiang_dong163@163.com

Locations
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China, Shanghai
Huashan Hospital Recruiting
Shanghai, Shanghai, China, 200040
Contact: Qiang Dong    +86-21-52887142    qiang_dong163@163.com   
Sponsors and Collaborators
Huashan Hospital
Shanghai 6th People's Hospital
Shanghai 10th People's Hospital
Shanghai East Hospital

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Responsible Party: Qiang Dong, Director of Neurology Department, Huashan Hospital
ClinicalTrials.gov Identifier: NCT04086147    
Other Study ID Numbers: 2017YFC1308201
First Posted: September 11, 2019    Key Record Dates
Last Update Posted: December 17, 2019
Last Verified: December 2019

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Studies a U.S. FDA-regulated Drug Product: No
Studies a U.S. FDA-regulated Device Product: No
Product Manufactured in and Exported from the U.S.: No
Keywords provided by Qiang Dong, Huashan Hospital:
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
Additional relevant MeSH terms:
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Stroke
Cerebrovascular Disorders
Brain Diseases
Central Nervous System Diseases
Nervous System Diseases
Vascular Diseases
Cardiovascular Diseases
Tenecteplase
Fibrinolytic Agents
Fibrin Modulating Agents
Molecular Mechanisms of Pharmacological Action