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

Официальное название

Tenecteplase Before inteRhospital Transfer for Endovascular Treatment in pAtientS With acUte Anterior ciRculation Large vEssel Occlusion at 4.5 to 24 Hours

Обзор

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.

Вмешательства

• Препарат Tenecteplase (TNK) (0.25 mg/kg, to maximum of 25mg)
  Tenecteplase at a nECC before EVT transfer

Первичные конечные точки

• Level of disability (ordinal mRS score) [Срок оценки: at 90 (±7) days]

Вторичные конечные точки (8)

• Excellent outcome [Срок оценки: at 90 (±7) days]
• Functional independence [Срок оценки: at 90 (±7) days]
• Ambulatory and self-care capable [Срок оценки: at 90 (±7) days]
• Health-related quality of life [Срок оценки: at 90 (±7) days]
• Incidence of arterial recanalization [Срок оценки: Day 1]
• First pass reperfusion [Срок оценки: intraoperative, immediately after the first pass]
• Successful reperfusion [Срок оценки: immediately after the endovascular intervention]
• Recanalization [Срок оценки: at 24 (±12) hours]

Критерии участия

Критерии включения

• 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 volume ≥15mL and mismatch ratio ≥1.8;

Alternative neuroimaging (if CTP or MRP is technically inadequate or unavailable):

The presence of a diffusion-weighted imaging (DWI)-fluid-attenuated inversion recovery (FLAIR) mismatch pattern (i.e., acute ischemic lesion visible on DWI but no marked parenchymal hyperintensity visible on FLAIR) OR an Alberta Stroke Program Early CT Score (ASPECTS) score ≥7 on NCCT or MRI scan;

Критерии исключения

• Known hypersensitivity or allergy to any ingredients of Tenecteplase;
• Intended to receive IVT as standard-of-care therapy;
• 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;
• 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;
• Ischemic stroke or myocardial infarction in previous 3 months
• Previous intracranial hemorrhage, active internal bleeding (gastrointestinal or urinary tract hemorrhage) in previous 3 months;
• 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;
• Baseline blood glucose <50mg/dl or >400mg/dl;
• 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);
• Evidence of intracranial tumor (mass effect), acute intracranial hemorrhage, or arteriovenous malformation;
• Current participation in another investigational drug or device study;
• Suspected endocarditis;
• 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;

Критерии приведены из реестра в оригинале (на английском). Окончательную оценку соответствия проводит исследовательский центр.

Здоровые добровольцы: Нет

Дизайн исследования

Распределение

Рандомизированное

Модель

Параллельные группы

Маскирование

Простое слепое

Основная цель

Лечение

Центры проведения

Китай · 2 центра

• Xuanwu Hospital Capital Medical University — Пекин
• Affiliated Hospital of Shandong Second Medical University — Weifang

Идентификаторы

NCT: NCT07253181 · [2025]372-001

Первоисточники (государственные реестры)

• ClinicalTrials.gov (NIH, США)

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