CHABLIS-T II: CHinese Acute Tissue-Based Imaging Selection for Lysis In Stroke -Tenecteplase II
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 |
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Phase 2 |
Study Design
Arms and Interventions
Arm | Intervention/Treatment |
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Experimental: Tenecteplase arm
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Drug: Tenecteplase
Intravenous (IV) tenecteplase 0.25 mg/kg (single bolus; maximum dose 25 mg)
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Other: nonthrombolysis drug arm (e.g. Aspirin)
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Drug: nonthrombolysis drug
nonthrombolysis drug
|
Outcome Measures
Primary Outcome Measures
- 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
- Imaging efficacy outcome: recanalization rate on CT/magnetic resonance angiography [4-6 hours]
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 [3-5 days]
Infarct volume growth (ml) at 3-5 days on MRI or CT perfusion
- Clinical efficacy outcome: NIHSS change [24 hours (plus or minus 2 hours)]
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) [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) [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 [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))
- Imaging safety outcome: Intracranial hemorrhage of any volume at 24-36 hours [24-36 hours]
Intracranial hemorrhage of any volume at 24-36 hours
- Imaging safety outcome: parenchymal hematoma 2 at 24-36 hours [24-36 hours]
Parenchymal hematoma 2 at 24-36 hours
- Imaging safety outcome: Symptomatic intracranial hemorrhage at 24-36 hours [24-36 hours]
Symptomatic intracranial hemorrhage at 24-36 hours
- Clinical safety outcome: death within 90 days [90 days (plus or minus 7 days)]
Death within 90 days (plus or minus 7 days)
- 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)
- 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.
- 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
- 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
- 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
- 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)
- 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
Inclusion Criteria:
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Patients presenting with anterior circulation acute ischaemic stroke
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Time from onset to treatment 4.5h-24h
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Patient's age is ≥18 years
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Pre-stroke mRS score of <= 2
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Clinically significant acute neurologic deficit
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Baseline National Institute of Health stroke scale >= 6
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Vessel occlusion or severe stenosis ( ICA, MCA-M1/M2, ACA) on computed tomography angiography (CTA)/MRA
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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
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Informed consent was obtained from patients.
Exclusion Criteria:
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Intracranial hemorrhage or subarachnoid hemorrhage identified by CT or MRI
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Rapidly improving symptoms (patient with an NIHSS score decrease to < 4 at randomization)
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Pre-stroke mRS score of > 2
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Contraindication to imaging with CT/magnetic resonance imaging with contrast agents
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Infarct core >1/3 middle cerebral artery (MCA) territory
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Platelet count < 100x10^9/L
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Symptoms were caused by low blood glucose < 2.7 mmol/l
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Severe uncontrolled hypertension, i.e. systolic blood pressure >= 180 mmHg or diastolic blood pressure >=100 mmHg
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Current use of warfarin with a prolonged prothrombin time (INR > 1.7 or prothrombin time > 15s)
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Use of low molecular weight heparin within 24 hours
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Use of non-vitamin K antagonist oral anticoagulants (NOACs) within 48 hours
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Use of glycoprotein IIb - IIIa inhibitors within 72 hours.
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Arterial puncture at noncompressible site in previous 7 days
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Major surgery in previous 14 days which poses risk in the opinion of the investigator
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Recent gastrointestinal or urinary tract hemorrhage (within previous 21 days)
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Significant head trauma or prior stroke in previous 3 months
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History of previous intracranial hemorrhage, intracranial neoplasm, arteriovenous malformation, or aneurysm. Risks were considered by the investigator
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Hereditary or acquired haemorrhagic diathesis
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Active internal bleeding
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Symptoms suggestive or recent acute pancreatitis, active gastrointestinal ulcer
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Severe liver disease, including liver failure, cirrhosis, portal hypertension and active hepatitis
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Pregnancy or lactation
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Various dying diseases with life expectancy ≤3 months
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Other conditions in which doctors believe that participating in this study may be harmful to the patient
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Patients participated in any trial in 30 days
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Allergic to the test drug and its ingredients
Contacts and Locations
Locations
Site | City | State | Country | Postal Code | |
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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.- SHDC2020CR1041B