Efficacy and Safety of Tenecteplase Intravenous Thrombolysis in Acute Posterior Circulation Ischemic Stroke Within 4.5-24 Hours After Onset

Официальное название

Efficacy and Safety of Tenecteplase Intravenous Thrombolysis in Acute Posterior Circulation Ischemic Stroke Within 4.5-24 Hours After Onset: A Multicenter, Prospective, Randomized, Open-Label, Blinded Endpoint Trial

Обзор

This study aims to evaluate the efficacy and safety of tenecteplase (TNK) intravenous thrombolysis within the extended time window (4.5 to 24 hours) in patients with acute posterior circulation ischemic stroke.

Подробное описание

This multicenter, prospective, randomized, controlled trial assesses the efficacy and safety of intravenous tenecteplase for acute posterior-circulation ischemic stroke treated 4.5-24 hours after onset. Participants with imaging-confirmed stroke will be randomly assigned 1:1 to receive either tenecteplase or standard medical therapy. Eligible patients must present within 4.5-24 hours from symptom onset, defined as the midpoint between last known normal and first observed neurological deficit. All participants will undergo telephone follow-up at 3 months and 1 year, with the modified Rankin Scale as the primary outcome measure.

Вмешательства

• Препарат TNK plus standard medical treatment
  Patients in the TNK treatment group will receive TNK intravenous thrombolysis and the usual dosage for TNK intravenous thrombolysis is 0.25mg/Kg, with a maximum of 25mg.
• Препарат standard medical management
  standard medical management

Первичные конечные точки

• Proportion of patients with modified Rankin Scale (mRS) score 0-1 at 90 ±14 days; [Срок оценки: 90 ±14 days]

Вторичные конечные точки (11)

• Proportion of patients with mRS score 0-2 at 90 ±14 days; [Срок оценки: 90 ±14 days]
• Proportion of patients with mRS score 0-3 at 90 ±14 days; [Срок оценки: 90 ±14 days]
• Ordinal distribution of mRS score at 90 ±14 days; [Срок оценки: 90 ±14 days]
• Change in NIHSS score at 24-36 hours post-treatment [Срок оценки: 24 hours post-treatment]
• 5)Change in NIHSS score at 5-7 days post-treatment; [Срок оценки: 5-7 days post-treatment]
• EQ-5D-5L questionnaire score at 90 ±14 days; [Срок оценки: 90 ±14 days]
• Barthel Index score at 90 ±14 days; [Срок оценки: 90 ±14 days]
• 1)Symptomatic intracranial hemorrhage within 36 hours (Heidelberg criteria) [Срок оценки: 24-36 hours after treatment]
• Any intracranial hemorrhage within 36 hours (Heidelberg criteria) [Срок оценки: 24-36 hours after treatment]
• Mortality rate at 90 ±14 days [Срок оценки: 90 ±14 days]
• Overall incidence of serious adverse events [Срок оценки: 90 ±14 days]

Критерии участия

Критерии включения

• Age ≥18 years.
• Meeting at least one of the following criteria: acute posterior circulation ischemic stroke confirmed by MRI; symptomatic stenosis or occlusion of a posterior circulation large vessel on vascular imaging (CTA/MRA/DSA); perfusion imaging demonstrating clinically relevant hypoperfusion in the posterior circulation territory.
• Onset time between 4.5-24 hours (for wake-up stroke or unwitnessed stroke, onset time is defined as the midpoint between last known well and symptom detection).
• NIHSS score>3.
• PC-ASPECTS ≥7 (if discrepancy exists between DWI and CT findings, CT assessment takes precedence).
• Pre-stroke mRS ≤1.
• Signed informed consent by the patient or legally authorized representative.

Критерии исключения

• Contraindication to tenecteplase or its components.
• Planing to receive endovascular therapy with thrombectomy, angioplasty or stenting whin 3 months.
• Acute anterior circulation infarction confirmed by MRI, anterior circulation large vessel occlusion on vascular imaging (CTA/MRA/DSA), or anterior circulation hypoperfusion on perfusion imaging.
• History of intracranial hemorrhage.
• Stroke, myocardial infarction, severe traumatic brain injury, or intracranial/spinal surgery within the preceding 3 months.
• Intracranial tumor, arteriovenous malformation (AVM), or giant aneurysm.
• Active internal bleeding, major surgery, trauma, gastrointestinal/urinary tract bleeding within 3 weeks.
• Non-compressible arterial puncture within 1 week.
• Suspected aortic dissection.
• Clinically significant bleeding or coagulopathy, including: Warfarin use with INR >1.7 or PT >15 s; Low-molecular-weight heparin within 24 hours; Direct oral anticoagulants within 48 hours; Laboratory abnormalities (e.g., APTT >40 s).
• Platelet dysfunction or platelet count <100×10⁹/L.
• Uncontrolled hypertension (systolic BP >180 mmHg or diastolic BP >110 mmHg unresponsive to antihypertensive therapy).
• Uncontrolled hypoglycemia/hyperglycemia (<50 mg/dL \[2.8 mmol/L\] or >400 mg/dL \[22.2 mmol/L\]).
• Pregnancy or lactation.
• A life expectancy of less than three months.
• Participation in other clinical trials within 3 months or ongoing trial enrollment.
• Inability to follow up (e.g., no fixed residence, overseas patients).
• Patient deemed unsuitable for the trial by site investigator.

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 · 1 центр

• The First Affiliated Hospital of the University of Science and Technology of China — Хэфэй

Идентификаторы

NCT: NCT07094763 · Attention-Extend IV

Первоисточники (государственные реестры)

• ClinicalTrials.gov (NIH, США)

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