Идёт набор NCT07550296

Repeated Intravenous Thrombolysis for Ischemic Stroke With Medium to Large Vessel Occlusion Presenting Within 4.5 Hours of Onset With Prourokinase

Фаза II С лечением Acute 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: prourokinase.
Кому может быть актуально: Состояния в реестре: Acute 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 Prourokinase (RITIS-PUK): a Prospective, Randomized, Open Label, Blinded Assessment of Outcome, and Multi-center Study

Обзор

Ischemic cerebrovascular disease is a common neurological disorder with high incidence, mortality, and disability. Early reperfusion to salvage the ischemic penumbra is the cornerstone of acute ischemic stroke (AIS) treatment. Current reperfusion strategies include intravenous thrombolysis (IVT) and endovascular therapy (EVT). Although alteplase is the first-line thrombolytic agent, its recanalization rate for large vessel occlusion (LVO) is only 10-20%, and for medium vessel occlusion (MeVO), approximately 50% of patients fail to achieve recanalization, leading to poor outcomes. Prourokinase has recently been shown to be non-inferior to alteplase with a better safety profile, and studies suggest that repeated thrombolysis may improve recanalization rates in patients without early clinical improvement after standard IVT. Therefore, this study aims to evaluate the efficacy and safety of an additional intravenous infusion of prourokinase in AIS patients with confirmed medium or large vessel occlusion who show no significant clinical improvement at 1 hour after standard IVT (within 4.5 hours of symptom onset). Patients without early neurological improvement (e.g., \<2-point reduction in NIHSS) and persistent vessel occlusion on imaging will receive a second dose of prourokinase. The primary outcomes include 24-hour recanalization rate (by CTA/MRA), 90-day functional outcome (modified Rankin Scale), and safety endpoints (symptomatic intracranial hemorrhage, mortality). The hypothesis is that additional prourokinase following standard IVT in non-improving patients with medium or large vessel occlusion will significantly increase recanalization rates and improve clinical outcomes without an unacceptable increase in symptomatic intracranial hemorrhage.

Вмешательства

Препарат prourokinase
Intravenous administration of prourokinase (20 mg infused over a 30-minute period)

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 intravenous thrombolysis of prourokinase, 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.