Back to resultsCHinese Acute Tissue-Based Imaging Selection for Lysis In Stroke -Tenecteplase II (CHABLIS-T II)
Primary Purpose
Stroke
Status
Recruiting
Phase
Phase 2
Locations
China
Study Type
Interventional
Intervention
Tenecteplase
The best treatment selected by local doctors(Aspirin, Recombinant Tissue Plasminogen Activator, Urokinase, Thrombectomy)
Sponsored by
About this trial
This is an interventional treatment trial for Stroke focused on measuring 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
Eligibility Criteria
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
Sites / Locations
- Huashan HospitalRecruiting
Arms of the Study
Arm 1
Arm 2
Arm Type
Experimental
Other
Arm Label
Tenecteplase arm
Best treatment arm (e.g. Aspirin, Recombinant Tissue Plasminogen Activator, Urokinase, Thrombectomy)
Arm Description
The best treatment selected by local doctors
Outcomes
Primary Outcome Measures
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
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
no symptomatic intracranial hemorrhage at 24-36 hours
No symptomatic intracranial hemorrhage at 24-36 hours
Secondary Outcome Measures
Imaging efficacy outcome: recanalization rate on CT/magnetic resonance angiography
Recanalization rate on CTA/MRA at 4-6 hours
Imaging efficacy outcome: Infarct volume growth (ml) at 3-5 days on MRI or CT perfusion
Infarct volume growth (ml) at 3-5 days on MRI or CT perfusion
Clinical efficacy outcome: NIHSS change
NIHSS change at 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)
percent of excellent functional outcome (modified Rankin scale 0-1) at 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)
percent of good functional outcome (modified Rankin scale 0-2) at 90 days (plus or minus 7 days)
Clinical efficacy outcome: incident event
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))
Imaging safety outcome: Intracranial hemorrhage of any volume at 24-36 hours
Intracranial hemorrhage of any volume at 24-36 hours
Imaging safety outcome: parenchymal hematoma 2 at 24-36 hours
Parenchymal hematoma 2 at 24-36 hours
Imaging safety outcome: Symptomatic intracranial hemorrhage at 24-36 hours
Symptomatic intracranial hemorrhage at 24-36 hours
Clinical safety outcome: death within 90 days
Death within 90 days (plus or minus 7 days)
Clinical safety outcome: Rate of systemic bleeding
Rate of systemic bleeding within 90 days (plus or minus 7 days)
Barthel index
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.
Imaging efficacy outcome: 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 without Parenchymal hematoma 2
Imaging efficacy outcome: 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 Parenchymal hematoma 2
Imaging efficacy outcome: recanalization rate on CT/magnetic resonance angiography at 3-5 days
Recanalization rate on CTA/MRA at 3-5 days
Clinical efficacy outcome: NIHSS change at 7 days
NIHSS change at 7 days (plus or minus 2 days)
Clinical efficacy outcome: vascular death within 90 days
Vascular death within 90 days (plus or minus 7 days) (stroke, cardiac infarct, pulmonary embolism)
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)
Major neurological improvement at 24-36 hours ( NIHSS reduction >8 or return to 0-1)
Full Information
NCT ID
NCT04516993
First Posted
August 14, 2020
Last Updated
September 20, 2022
Sponsor
Huashan Hospital
Collaborators
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, Shanghai 7th People's Hospital, Yangpu District Center Hospital, Nei Monggol keshketeng banner ZhongMeng hospital, Hai'an City People's Hospital, First Affiliated Hospital of Harbin Medical University, The First Affiliated Hospital of Suzhou Medical University, Huaian No.2 People's Hospital, The Second Affiliated Hospital of Chongqing Medical University
1. Study Identification
Unique Protocol Identification Number
NCT04516993
Brief Title
CHinese Acute Tissue-Based Imaging Selection for Lysis In Stroke -Tenecteplase II
Acronym
CHABLIS-T II
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
Study Type
Interventional
2. Study Status
Record Verification Date
September 2022
Overall Recruitment Status
Recruiting
Study Start Date
September 28, 2021 (Actual)
Primary Completion Date
December 1, 2022 (Anticipated)
Study Completion Date
December 31, 2022 (Anticipated)
3. Sponsor/Collaborators
Responsible Party, by Official Title
Principal Investigator
Name of the Sponsor
Huashan Hospital
Collaborators
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, Shanghai 7th People's Hospital, Yangpu District Center Hospital, Nei Monggol keshketeng banner ZhongMeng hospital, Hai'an City People's Hospital, First Affiliated Hospital of Harbin Medical University, The First Affiliated Hospital of Suzhou Medical University, Huaian No.2 People's Hospital, The Second Affiliated Hospital of Chongqing Medical University
4. Oversight
Studies a U.S. FDA-regulated Drug Product
No
Studies a U.S. FDA-regulated Device Product
No
5. 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
6. Conditions and Keywords
Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
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
7. Study Design
Primary Purpose
Treatment
Study Phase
Phase 2
Interventional Study Model
Parallel Assignment
Masking
Outcomes Assessor
Allocation
Randomized
Enrollment
224 (Anticipated)
8. Arms, Groups, and Interventions
Arm Title
Tenecteplase arm
Arm Type
Experimental
Arm Title
Best treatment arm (e.g. Aspirin, Recombinant Tissue Plasminogen Activator, Urokinase, Thrombectomy)
Arm Type
Other
Arm Description
The best treatment selected by local doctors
Intervention Type
Drug
Intervention Name(s)
Tenecteplase
Intervention Description
Intravenous (IV) tenecteplase 0.25 mg/kg (single bolus; maximum dose 25 mg)
Intervention Type
Drug
Intervention Name(s)
The best treatment selected by local doctors(Aspirin, Recombinant Tissue Plasminogen Activator, Urokinase, Thrombectomy)
Intervention Description
Best treatment arm
Primary Outcome Measure Information:
Title
patients without endovascular therapy obtained >50% reperfusion at 4-6 hours
Description
Without endovascular therapy: >50% reperfusion on computed tomography perfusion (CTP) at 4-6 hours
Time Frame
4-6 hours
Title
patients with endovascular therapy: mTICI score 2b or better at initial angiogram
Description
With endovascular therapy: mTICI score 2b or better at initial angiogram after thrombolysis before endovascular therapy
Time Frame
Before endovascular therapy
Title
no symptomatic intracranial hemorrhage at 24-36 hours
Description
No symptomatic intracranial hemorrhage at 24-36 hours
Time Frame
24-36 hours
Secondary Outcome Measure Information:
Title
Imaging efficacy outcome: recanalization rate on CT/magnetic resonance angiography
Description
Recanalization rate on CTA/MRA at 4-6 hours
Time Frame
4-6 hours
Title
Imaging efficacy outcome: Infarct volume growth (ml) at 3-5 days on MRI or CT perfusion
Description
Infarct volume growth (ml) at 3-5 days on MRI or CT perfusion
Time Frame
3-5 days
Title
Clinical efficacy outcome: NIHSS change
Description
NIHSS change at 24 hours (plus or minus 2 hours)
Time Frame
24 hours (plus or minus 2 hours)
Title
Clinical efficacy outcome: percent of excellent functional outcome (modified Rankin scale 0-1) at 90 days (plus or minus 7 days)
Description
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)
Title
Clinical efficacy outcome: percent of good functional outcome (modified Rankin scale 0-2) at 90 days (plus or minus 7 days)
Description
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)
Title
Clinical efficacy outcome: incident event
Description
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))
Time Frame
90 days (plus or minus 7 days)
Title
Imaging safety outcome: Intracranial hemorrhage of any volume at 24-36 hours
Description
Intracranial hemorrhage of any volume at 24-36 hours
Time Frame
24-36 hours
Title
Imaging safety outcome: parenchymal hematoma 2 at 24-36 hours
Description
Parenchymal hematoma 2 at 24-36 hours
Time Frame
24-36 hours
Title
Imaging safety outcome: Symptomatic intracranial hemorrhage at 24-36 hours
Description
Symptomatic intracranial hemorrhage at 24-36 hours
Time Frame
24-36 hours
Title
Clinical safety outcome: death within 90 days
Description
Death within 90 days (plus or minus 7 days)
Time Frame
90 days (plus or minus 7 days)
Title
Clinical safety outcome: Rate of systemic bleeding
Description
Rate of systemic bleeding within 90 days (plus or minus 7 days)
Time Frame
90 days (plus or minus 7 days)
Title
Barthel index
Description
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.
Time Frame
90 days (plus or minus 7 days)
Title
Imaging efficacy outcome: patients without endovascular therapy obtained >50% reperfusion at 4-6 hours
Description
Without endovascular therapy: >50% reperfusion on computed tomography perfusion (CTP) at 4-6 hours without Parenchymal hematoma 2
Time Frame
4-6 hours
Title
Imaging efficacy outcome: patients with endovascular therapy: mTICI score 2b or better at initial angiogram
Description
With endovascular therapy: mTICI score 2b or better at initial angiogram after thrombolysis before endovascular therapy Parenchymal hematoma 2
Time Frame
Before endovascular therapy
Title
Imaging efficacy outcome: recanalization rate on CT/magnetic resonance angiography at 3-5 days
Description
Recanalization rate on CTA/MRA at 3-5 days
Time Frame
3-5 days
Title
Clinical efficacy outcome: NIHSS change at 7 days
Description
NIHSS change at 7 days (plus or minus 2 days)
Time Frame
7 days (plus or minus 2 days)
Title
Clinical efficacy outcome: vascular death within 90 days
Description
Vascular death within 90 days (plus or minus 7 days) (stroke, cardiac infarct, pulmonary embolism)
Time Frame
90 days (plus or minus 7 days)
Title
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)
Description
Major neurological improvement at 24-36 hours ( NIHSS reduction >8 or return to 0-1)
Time Frame
24-36 hours
10. Eligibility
Sex
All
Minimum Age & Unit of Time
18 Years
Maximum Age & Unit of Time
80 Years
Accepts Healthy Volunteers
No
Eligibility Criteria
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
Central Contact Person:
First Name & Middle Initial & Last Name or Official Title & Degree
Qiang Dong, MD, PhD
Phone
86-21-52887142
Email
qiang_dong163@163.com
Facility Information:
Facility Name
Huashan Hospital
City
Shanghai
State/Province
Shanghai
ZIP/Postal Code
200040
Country
China
Individual Site Status
Recruiting
Facility Contact:
First Name & Middle Initial & Last Name & Degree
Qiang Dong
Phone
+86-21-52887142
Email
qiang_dong163@163.com
12. IPD Sharing Statement
Learn more about this trial
CHinese Acute Tissue-Based Imaging Selection for Lysis In Stroke -Tenecteplase II
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