NCT07253181 Tenecteplase Before Interhospital Transfer for EVT in Acute Anterior Circulation LVO at 4.5-24 Hours
| NCT ID | NCT07253181 |
| Status | Recruiting |
| Phase | Phase 3 |
| Sponsor | Xuanwu Hospital, Beijing |
| Condition | Acute Ischemic Stroke |
| Study Type | INTERVENTIONAL |
| Enrollment | 572 participants |
| Start Date | 2026-01-06 |
| Primary Completion | 2028-03-30 |
Trial Parameters
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Brief Summary
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 an endovascular capable center (ECC) for endovascular treatment (EVT). * Primary objective: To evaluate the efficacy and safety of Tenecteplase administration at a nECC before EVT transfer compared with standard of care * Secondary objective: 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) before transfer or standard of care. A single bolus dose should be injected over 5 seconds.
Eligibility Criteria
Inclusion Criteria: * 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), 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 (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: ICA or M1, M2 occlusion 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
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