Идёт набор NCT07375966

Repeated Intravenous Thrombolysis for Ischemic Stroke With Medium to Large Vessel Occlusion Presenting Within 4.5 Hours of Onset With Tenecteplase (RITIS-TNK2)

Фаза II С лечением Ischemic Stroke

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: Tenecteplase.
Кому может быть актуально: Состояния в реестре: Ischemic Stroke. Базовые параметры: 18 лет — 80 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: Китай
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

Repeated Intravenous Thrombolysis for Ischemic Stroke With Medium to Large Vessel Occlusion Presenting Within 4.5 Hours of Onset With Tenecteplase (RITIS-TNK2): a Prospective, Randomized, Open Label, Blinded Assessment of Outcome, and Multi-center Study

Обзор

While intravenous thrombolysis (IVT) within 4.5 hours is the standard medical reperfusion therapy, its efficacy is limited, particularly for large or medium vessel occlusions (LVO/MeVO), with low recanalization rates for IVT with rt-PA. The newer thrombolytic agent, tenecteplase (TNK), offers practical advantages-including single bolus administration, a longer half-life, and potentially higher fibrin specificity-and has been shown to be non-inferior to rt-PA. Despite advances, a significant proportion of patients with LVO/MeVO do not achieve early clinical improvement after standard IVT, likely due to persistent occlusion from a high thrombus burden. Endovascular therapy, while highly effective for LVO, has limited accessibility. Therefore, there is an urgent need for more effective and widely accessible pharmacological strategies. This study proposes a rescue strategy based on the hypothesis that a second dose of IVT may improve outcomes in patients with imaging-confirmed LVO or MeVO who show no significant neurological improvement one hour after standard TNK thrombolysis (administered within 4.5 hours of stroke onset). The primary aim of this study is to formally evaluate the efficacy and safety of a repeated dose of intravenous tenecteplase in this specific patient population.

Вмешательства

Препарат Tenecteplase
Tenecteplase is administered intravenously at a dose of 16 mg, with a maximum dose of 0.25 mg/kg.

Первичные конечные точки

rate of vessel recanalization [Срок оценки: 24 (-6/+12) hours]

Вторичные конечные точки (11)

proportion of excellent functional outcome (modified Rankin Scale (mRS) 0-1) [Срок оценки: 90±7 days]
proportion of favorable functional outcome (modified Rankin Scale (mRS) 0-2) [Срок оценки: 90±7 days]
ordinal distribution of modified Rankin Scale (mRS) [Срок оценки: 90±7 days]
occurrence of early neurological improvement (ENI) [Срок оценки: 24 (-6/+12) hours]
change in National Institute of Health stroke scale (NIHSS) score [Срок оценки: 24 (-6/+12) hours]
change in National Institute of Health stroke scale (NIHSS) score [Срок оценки: 10±2 days]
all-cause mortality [Срок оценки: 10±2 days]
occurence of symptomatic intracranial hemorrhage (sICH) [Срок оценки: 24 (-6/+12) hours]
occurence of any intracranial hemorrhage [Срок оценки: 24 (-6/+12) hours]
occurence of major systemic bleeding event [Срок оценки: 24 (-6/+12) hours]
occurence of any bleeding event [Срок оценки: 24 (-6/+12) hours]

Критерии участия

Критерии включения

Age ≥ 18 year;
Acute ischemic stroke presumably caused by large or medium vessel occlusion within 4.5 hours of onset, having received standard-dose intravenous thrombolysis, and with no planned thrombectomy;
Measurable neurological deficit before the first intravenous thrombolysis, with NIHSS ≥ 4;
Baseline pc-ASPECTS/ASPECTS ≥ 6, and for posterior circulation infarction, a Pontine-Midbrain Index ≤ 2 (assessed by CT or DWI);
No significant clinical improvement (reduction in NIHSS ≤ 2) or neurological deterioration after initial improvement at 1 hour after the first thrombolysis;
Follow-up imaging (CTA or MRA) at 1 hour after the first thrombolysis rules out intracranial hemorrhage and confirms the presence of large or medium vessel occlusion (internal carotid artery, M1-M3 segments of the middle cerebral artery, A1-A3 segments of the anterior cerebral artery, P1-P3 segments of the posterior cerebral artery, basilar artery or V4 segment of the vertebral artery, PICA, AICA, or SCA);
The second intravenous thrombolysis can be administered within 6 hours of onset;
First stroke onset or past stroke without obvious neurological deficit (mRS≤1);
Signed informed consent.