Ischemic stroke due to acute anterior circulation large vessel occlusion
Conditions
Interventions
Interventional group:Tenecteplase before EVT transfer
Sponsors
Xuanwu Hospital Capital Medical University
Eligibility
Sex/Gender
All
Age
18 Years to No maximum
Inclusion criteria
Inclusion criteria: 1.Age of 18 years or older; 2.AIS symptom onset within 4.5 to 24 hours, stroke onset is defined as the time the patient was last known to be well (including wake-up stroke and unwitnessed stroke); 3.Signs and symptoms consistent with the diagnosis of an acute anterior circulation ischemic stroke involving occlusion of the internal carotid artery (ICA), M1 or proximal M2 vessels; 4.Functionally independent (mRS 0-2) prior to stroke onset; 5.Baseline National Institute of Health Stroke Scale (NIHSS) of 6-25; 6.Intended to transfer to ECCs for EVT (patient transfer), or intended to transfer a neurointerventionalist from the ECC for EVT (physician transfer); 7.Written informed consent from patients or legally authorized representatives; 8.Neuroimaging: large vessel occlusion (ICA, M1, or proximal M2) by MRA or CTA AND the target mismatch profile on computed tomography perfusion (CTP) or magnetic resonance perfusion (MRP), defined as an ischemic core volume <70mL, mismatch volume =15mL and mismatch ratio =1.8; Alternative neuroimaging (if CTP or MRP is technically inadequate or unavailable): - An Alberta Stroke Program Early CT Score (ASPECTS) score =7 on NCCT or MRI scan;
Exclusion criteria
Exclusion criteria: 1. Known hypersensitivity or allergy to any ingredients of Tenecteplase; 2. Intended to receive IVT as standard-of-care therapy; 3. Rapidly improving symptoms with NIHSS score 1.7 or prothrombin time >15s; if use of any direct oral anticoagulant within the last 48 hours; if on any full dose heparin/heparinoid within the last 24 hours; 7. Ischemic stroke or myocardial infarction in previous 3 months; 8. Previous intracranial hemorrhage, active internal bleeding (gastrointestinal or urinary tract hemorrhage) in previous 3 months; 9. Severe, uncontrolled hypertension (systolic blood pressure >180 mmHg or diastolic blood pressure >110 mmHg); 10. Other serious, advanced or terminal illness with life expectancy less than 6 months; 11. Baseline blood glucose 400mg/dl; 12. Contraindication to imaging with contrast agents; 13. Acute symptomatic arterial occlusions in more than one vascular territory confirmed on CTA or MRA (e.g. bilateral MCA occlusions, or an MCA and a basilar artery occlusion); 14. Extensive early ischemic change (hypodensity) on NCCT or MRI-DWI lesions estimated to be >1/3 MCA territory; significant hypodensity outside the Tmax>6s perfusion lesion that invalidates mismatch criteria (if patient is enrolled based on CT perfusion criteria); any CT or MRI findings indicative of a high risk of sICH related to potential intravenous tenecteplase treatment in the judgement of the investigator; 15. Evidence of intracranial tumor (mass effect), acute intracranial hemorrhage, or arteriovenous malformation; 16. Current participation in another investigational drug or device study; 17.Suspected endocarditis; 18. Any condition that, in the judgment of the investigator could impose hazards to the patient if study therapy is initiated or affect the participation of the patient in the study.
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| ordinal mRS score; | — |
Secondary
| Measure | Time frame |
|---|---|
| Score on the EQ-5D-5L;Dichotomized mRS of 0-3 vs. 4-6;Incidence of arterial recanalization;All-cause mortality;Recanalization at 24 (+/-12) hours;Symptomatic intracranial hemorrhage (sICH);Dichotomized mRS of 0-2 vs. 3-6;First pass reperfusion;Successful reperfusion;Dichotomized mRS of 0-1 vs. 2-6;Parenchymal hematoma type 2; | — |
Countries
China
Contacts
Public ContactJunwei Hao
Xuanwu Hospital Capital Medical University
Outcome results
None listed