Status:
COMPLETED
CHinese Acute Tissue-Based Imaging Selection for Lysis In Stroke -Tenecteplase II
Lead Sponsor:
Huashan Hospital
Collaborating Sponsors:
Puer People's Hospital
Shanghai 6th People's Hospital
Conditions:
Stroke
Eligibility:
All Genders
18-80 years
Phase:
PHASE2
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
Eligibility Criteria
Inclusion
- 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
- 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
Key Trial Info
Start Date :
September 28 2021
Trial Type :
INTERVENTIONAL
Allocation :
ACTUAL
End Date :
September 30 2023
Estimated Enrollment :
224 Patients enrolled
Trial Details
Trial ID
NCT04516993
Start Date
September 28 2021
End Date
September 30 2023
Last Update
November 29 2023
Active Locations (1)
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1
Huashan Hospital
Shanghai, Shanghai Municipality, China, 200040