Adjunctive Intra-arterial Tenecteplase Following Mechanical Thrombectomy (ALLY) II Trial

Обзор

The study objective is to evaluate the safety and efficacy of Intra arterial (IA) Tenecteplase (TNK) as an adjunctive therapy in acute ischemic stroke (AIS) patients with large vessel occlusions (LVO) in the anterior circulation of Internal Carotid Artery (ICA), Middle Cerebral Arteries (M1 and M2) who achieve a reperfusion grade of Modified Treatment in Cerebral Ischemia Scale (mTICI) 2b or higher post-mechanical thrombectomy using Food and Drug Administration (FDA) approved devices.

Вмешательства

• Препарат tenecteplase
  Patients treated with standard of care mechanical thrombectomy (MT) that achieved mTICI 2b or higher revascularization. Patients will be randomized into one of two arms: IA TNK or control.

Первичные конечные точки

• Primary Efficacy Endpoint- Modified Rankin Scale (mRS) [Срок оценки: 90 days (+/- 30 days) post treatment.]
• Primary Safety Endpoint- Incidence of Intracranial hemorrhage and Neurologic Worsening [Срок оценки: 24 hours (+/-12 hours) post treatment.]

Вторичные конечные точки (8)

• Ordinal Modified Rankin Scale (mRS) [Срок оценки: 90 days (+/-30 days) post treatment.]
• Functional Independence [Срок оценки: 90 days (+/- 30 days) post treatment.]
• Final Revascularization Grade [Срок оценки: Immediate post treatment.]
• Mortality rate at 90 days [Срок оценки: Mortality rate at 90-days (+/- 30 days) post treatment.]
• Mortality Rate at discharge [Срок оценки: Day 6 (+/-1 day) or Discharge post treatment.]
• Infarct Volume Post Procedure [Срок оценки: 24 hours (+/- 12 hours) post treatment.]
• Asymptomatic Intracranial hemorrhage [Срок оценки: 24 hours (+/- 12 hours) post treatment.]
• Mean Number of Boluses [Срок оценки: Immediate post procedure.]

Критерии участия

Критерии включения

• Age 18-85
• Anterior circulation ischemic stroke symptoms with confirmed occlusion (ICA, M1, or M2) on angiogram and mechanical thrombectomy initiated within 24 hours since last known well
• Alberta Stroke Program Early CT Score (ASPECTS) Score ≥6 on baseline Non-contrast Head CT (NCCT)
• Post-mechanical thrombectomy with ≤5 device passes and mTICI grade 2b or higher.
• Ability to obtain signed informed consent prior to randomization from LAR or Subject

Критерии исключения

• Premorbid modified Rankin scale (mRS) score >1
• Imaging evidence of hemorrhage or mass effect at baseline
• Platelet count <100,000
• Active hemorrhagic diathesis, or known hereditary or acquired hemorrhagic diathesis, coagulation factor deficiency
• Active anticoagulation treatment with novel oral anticoagulant (NOACs) taken within the last 48 hours, or INR >1.7
• Patients requiring active treatment with dual antiplatelet agents (e.g. proximal cervical carotid artery stenting)
• Pregnant or lactating
• Previous known allergy to TNK
• Major surgery in past 30 days
• Patient is on or requires dialysis
• History of intracranial hemorrhage or serious head trauma at any time
• Any condition in the opinion of the enrolling physician that would preclude the patient from participating
• Pre-existing medical, neurological, or psychiatric disease that would confound the neurological or functional evaluation
• Severe, uncontrolled hypertension (systolic blood pressure >180 mmHg or diastolic blood pressure >110 mmHg) that is refractory to treatment
• History of acute ischemic stroke in the last 60 days and/or has received previous treatment with a thrombolytic within the last 90 days
• Presumed septic embolus; suspicion of bacterial endocarditis
• Suspicion of aortic dissection
• Intracranial neoplasm
• Any terminal medical condition with life expectancy less than 6 months
• Concurrent enrollment in another trial that could confound the results of this study
• Patient is unlikely to return for 90-day follow-up.
• Intravenous tissue plasminogen activator (tPA) administered concurrently with Intra-arterial TNK

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

Открытое

Основная цель

Лечение

Центры проведения

США · 1 центр

• ProMedica Toledo Hospital — Toledo

Публикации

• Zaidi SF, Castonguay AC, Zaidat OO, Jadhav AP, Sheth SA, Haussen DC, Nguyen TN, Burgess RE, Alhajala HS, Gharaibeh K, Salahuddin H, Rao R, Oliver MJ, Jumaa MA. Safety of Adjunctive Intraarterial Tenecteplase Following Mechanical Thrombectomy: The ALLY Pilot Trial. Stroke. 2025 Feb;56(2):355-361. doi: 10.1161/STROKEAHA.124.048846. Epub 2025 Jan 8. PMID 39772606

Идентификаторы

NCT: NCT06949228 · ALLY II

Первоисточники (государственные реестры)

• ClinicalTrials.gov (NIH, США)

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