Tenecteplase Before inteRhospital Transfer for Endovascular Treatment in pAtientS With acUte Anterior ciRculation Large vEssel Occlusion at 4.5 to 24 Hours
This study will address the efficacy and safety of Tenecteplase administered in non-endovascular capable center (nECC) in patients with acute ischemic stroke (AIS) caused by anterior circulation large vessel occlusion (acLVO) who present in the 4.5- to 24-hour time window before interhospital transfer to a endovascular capable center (ECC) for endovascular treatment (EVT). * Primary objective: To evaluate the efficacy of Tenecteplase administration at a nECC before EVT transfer compared with direct transfer on 90-day function outcomes; * Secondary objective and further: To evaluate the safety of Tenecteplase administration at a nECC before EVT transfer; To evaluate the impact of time from needle-to-arterial puncture on clinical outcomes. Patients who meet inclusion criteria will be randomized to Tenecteplase (0.25mg/kg, maximum 25mg) administered before transfer or direct transfer to ECCs. A single bolus dose should be injected over 5 seconds.
• Age of 18 years or older;
• 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);
• Signs and symptoms consistent with the diagnosis of an acute anterior circulation ischemic stroke involving occlusion of the internal carotid artery (ICA), MCA (M1 or 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;
• Written informed consent from patients or legally authorized representatives;
• Neuroimaging:
⁃ ICA or M1, M2 occlusion by magnetic resonance angiography (MRA) or computed tomography angiography (CTA) and ANY of the following:
∙ if CT perfusion (CTP) or MR perfusion (MRP) is performed, target mismatch is defined as ischemic core volume \<70mL, mismatch volume ≥15mL and mismatch ratio ≥1.8;
‣ if CTP or MRP is technically inadequate, an ASPECTS score should be of 7 or more evidenced by CT or MRI scan;