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

Sponsor
Huashan Hospital (Other)
Overall Status
Recruiting
CT.gov ID
NCT04516993
Collaborator
Shanghai 5th People's Hospital (Other), Shanghai 10th People's Hospital (Other), Shanghai East Hospital (Other), ShuGuang Hospital (Other), Shanghai 6th People's Hospital (Other), The First Affiliated Hospital of Shanxi Medical University (Other), Ningbo No. 1 Hospital (Other), Pu'er City People's Hospital (Other), Zhejiang Province People's Hospital (Other)
224
1
2
15.1
14.9

Study Details

Study Description

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

Condition or Disease Intervention/Treatment Phase
Phase 2

Study Design

Study Type:
Interventional
Anticipated Enrollment :
224 participants
Allocation:
Randomized
Intervention Model:
Parallel Assignment
Masking:
Single (Outcomes Assessor)
Primary Purpose:
Treatment
Official 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
Actual Study Start Date :
Sep 28, 2021
Anticipated Primary Completion Date :
Dec 1, 2022
Anticipated Study Completion Date :
Dec 31, 2022

Arms and Interventions

Arm Intervention/Treatment
Experimental: Tenecteplase arm

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

Other: nonthrombolysis drug arm (e.g. Aspirin)

Drug: nonthrombolysis drug
nonthrombolysis drug

Outcome Measures

Primary Outcome Measures

  1. modified Rankin scale change [90 days (plus or minus 7 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.

Secondary Outcome Measures

  1. Imaging efficacy outcome: recanalization rate on CT/magnetic resonance angiography [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 [3-5 days]

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

  3. Clinical efficacy outcome: NIHSS change [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) [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) [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 [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 [24-36 hours]

    Intracranial hemorrhage of any volume at 24-36 hours

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

    Parenchymal hematoma 2 at 24-36 hours

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

    Symptomatic intracranial hemorrhage at 24-36 hours

  10. Clinical safety outcome: death within 90 days [90 days (plus or minus 7 days)]

    Death within 90 days (plus or minus 7 days)

  11. Clinical safety outcome: Rate of systemic bleeding [90 days (plus or minus 7 days)]

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

  12. Barthel index [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 [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 [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 [3-5 days]

    Recanalization rate on CTA/MRA at 3-5 days

  16. Clinical efficacy outcome: NIHSS change at 7 days [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 [90 days (plus or minus 7 days)]

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

Eligibility Criteria

Criteria

Ages Eligible for Study:
18 Years and Older
Sexes Eligible for Study:
All
Accepts Healthy Volunteers:
No
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. 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:
  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 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

Contacts and Locations

Locations

Site City State Country Postal Code
1 Huashan Hospital Shanghai Shanghai China 200040

Sponsors and Collaborators

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

Investigators

None specified.

Study Documents (Full-Text)

None provided.

More Information

Publications

None provided.
Responsible Party:
Qiang Dong, Director of Neurology Department, Huashan Hospital
ClinicalTrials.gov Identifier:
NCT04516993
Other Study ID Numbers:
  • SHDC2020CR1041B
First Posted:
Aug 18, 2020
Last Update Posted:
Jul 7, 2022
Last Verified:
Jul 1, 2022
Studies a U.S. FDA-regulated Drug Product:
No
Studies a U.S. FDA-regulated Device Product:
No
Keywords provided by Qiang Dong, Director of Neurology Department, Huashan Hospital
Additional relevant MeSH terms:

Study Results

No Results Posted as of Jul 7, 2022