Идёт набор NCT05892510

Post-thrombectomy Intra-arterial Tenecteplase for Acute manaGement of Non-retrievable Thrombus and No-reflow in Emergent Stroke

Фаза II / Фаза III С лечением Ischemic Stroke, Acute Cerebrovascular Disorders Brain Disorder Central Nervous System Diseases

Ориентир для пациента и семьи

Простыми словами

Автоматическая сводка по структурированным данным реестра. Она помогает сориентироваться, но не заменяет официальный протокол или оценку врача.

Что изучают: В протоколе указаны: Intra-arterial tenecteplase injection at the completion of thrombectomy, Placebo.
Кому может быть актуально: Состояния в реестре: Ischemic Stroke, Acute, Cerebrovascular Disorders, Brain Disorder, Central Nervous System Diseases. Базовые параметры: от 18 лет · Все.
Что важно проверить: Возраст, диагноз и пол — только базовые ориентиры. Предыдущее лечение, анализы и другие обязательные условия указаны ниже в критериях участия.
Где проводится: Австралия, Новая Зеландия
Следующий шаг: Сохраните исследование, покажите его лечащему врачу и уточните актуальный статус у исследовательского центра. Расходы, документы и поездка →

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Официальное название

Post-thrombectomy Intra-arterial Tenecteplase for Acute manaGement of Non-retrievable Thrombus and No-reflow in Emergent Stroke (EXTEND-AGNES TNK)

Обзор

Multicentre, prospective, Multi-arm Multi-stage (MAMS) seamless phase 2b/3 interventional randomized placebo-controlled double-blinded parallel-assignment (2 arms with 1:1 randomization) efficacy and safety trial to test intra-arterial tenecteplase at the completion of thrombectomy versus best practice in participants with anterior circulation LVO receiving mechanical thrombectomy within 24 hours of symptoms onset.

Вмешательства

Препарат Intra-arterial tenecteplase injection at the completion of thrombectomy
Intra-arterial tenecteplase (0.062mg/kg, maximum 6.25mg) administered as a bolus at the completion of thrombectomy through a microcatheter at the site of the initial-but-now-retrieved intracranial occlusion, or in direct contact with the residual thrombus
Препарат Placebo
intra-arterial bolus of 0.9% Sodium Chloride solution

Первичные конечные точки

Early Neurological Improvement (Phase 2b) [Срок оценки: 24-36 hours from time of randomisation]
Functional independence (Phase 3) [Срок оценки: 3 months]

Вторичные конечные точки (6)

Functional improvement [Срок оценки: 3 months]
Infarct growth [Срок оценки: 24 hours]
No-reflow [Срок оценки: 24 hours]
Symptomatic Intracerebral Hemorrhage [Срок оценки: 36 hours]
All cause mortality [Срок оценки: 3 months]
Quality of life assessment on EQ-5D [Срок оценки: 3 months]

Критерии участия

Критерии включения

Adult participants (age≥18 years) presenting with ischemic stroke with arterial LVO on CT/MR Angiogram of the intracranial internal carotid or middle cerebral artery (MCA) first segment (M1) or proximal second segment (M2) committed to thrombectomy using standard criteria within 24 hours of onset:
For 0-6 hours of symptom onset: Presence of arterial occlusion as defined above and ASPECTS≥3 on NCCT
For 6-24 hours of symptom onset: Additional imaging criteria on CTP or MRI perfusion of core volume <100ml.
Qualifying CT/MR within 4hrs of randomisation (repeat CT for transferred participants required if >4hr)
Pre-stroke Modified Rankin Scale (mRS) score of ≤2 (mild pre-existing disability permitted)
Local legal requirements for consent have been satisfied.

Критерии исключения

Intracranial hemorrhage identified by CT or MRI
ASPECTS 0-2 on NCCT
CTP or MRI perfusion ischemic core volume >100ml if presenting within 6-24 hours from symptoms onset
Anticipated endovascular stenting required for intracranial or extracranial atherosclerotic stenosis/occlusion.
More than six retrieval attempts in the same vessel
Alteplase being infused within 30 minutes (\~5x half-life) of anticipated trial drug administration
Contraindication to imaging with contrast agents
Any condition (eg.mid-arterial phase early venous filling) that in the judgment of investigators could impose hazards if study therapy is initiated
Pregnant women.
Current participation in another intervention research study that includes experimental interventions beyond standard-of-care.
Anticoagulation. INR ≤1.7 if on warfarin, and dabigatran reversal by idarucizumab are permitted.
Other standard contraindications to thrombolysis apart from time window.
Known terminal illness such that the participants would not be expected to survive a year.
Planned withdrawal of care or comfort care measures.

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

Здоровые добровольцы: Нет