Tenecteplase Before Interhospital Transfer for EVT in Acute Anterior Circulation LVO at 4.5-24 Hours

Korábbi kezelés

• Intended to receive IVT as standard-of-care therapy;
• Ischemic stroke or myocardial infarction in previous 3 months
• Previous intracranial hemorrhage, active internal bleeding (gastrointestinal or urinary tract hemorrhage) in previous 3 months;
• Current participation in another investigational drug or device study;

Más betegség

• Known hypersensitivity or allergy to any ingredients of Tenecteplase;
• Severe, uncontrolled hypertension (systolic blood pressure >180 mmHg or diastolic blood pressure >110 mmHg);
• Other serious, advanced or terminal illness with life expectancy less than 6 months;
• Evidence of intracranial tumor (mass effect), acute intracranial hemorrhage, or arteriovenous malformation;
• 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;

Laborértékek

• Impairment in coagulation due to comorbid disease or anticoagulant use. If on warfarin, INR >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;
• Baseline blood glucose <50mg/dl or >400mg/dl;

Egyéb

• Rapidly improving symptoms with NIHSS score <6 before randomization;
• Any contra-indication for IVT except for the time criterion;
• Known hereditary or acquired hemorrhagic diathesis;
• Contraindication to imaging with contrast agents;
• 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);
• Extensive early ischemic change on non-contrast CT or MRI-DWI estimated to be >1/3 MCA territory, or 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;
• Suspected endocarditis;

• Age of 18 years or older;
• AIS symptom onset to treatment initiation 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);
• 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;
• Functionally independent (mRS 0-2) prior to stroke onset;
• Baseline National Institute of Health Stroke Scale (NIHSS) of 6-25;
• Intended to transfer to ECCs for EVT (patient transfer), or intended to transfer a neurointerventionalist from the ECC for EVT (physician transfer);
• Written informed consent from patients or legally authorized representatives;
• Neuroimaging: large vessel occlusion (ICA, M1, 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;