Идёт набор NCT07361302

A Study to Test if Tenecteplase Helps People to Recover From an Acute Stroke When Given More Than 4.5 Hours After the Person Was Last Seen Well

Фаза III 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: Tenecteplase, Standard of care treatment.
Кому может быть актуально: Состояния в реестре: Acute Ischemic Stroke. 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: Аргентина, Австралия, Болгария, Китай, Греция +11
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

TENACITY - A Phase III, Prospective, Randomized, Open-label, Blinded Endpoint Assessment (PROBE) to Assess Efficacy and Safety of i.v. Tenecteplase vs Standard of Care in Patients With Acute Ischemic Stroke (Including Wake-up Stroke), Last Known Well >4.5 h With Imaging Evidence of Salvageable Ischemic Tissue

Обзор

This study is open to adults who had an acute stroke caused by a clot blocking a blood vessel in the brain (acute ischemic stroke). This study is for people who had an acute stroke or woke up with a stroke and were last seen well more than 4.5 hours before joining the study. Participants need to have imaging that shows there is brain tissue that can still be saved. They also should not be planned to receive a procedure to remove the blood clot. The purpose of this study is to find out whether a medicine called tenecteplase helps people recover from an acute stroke. Tenecteplase is already used to treat people within 4.5 hours after they had a stroke. This study tests if tenecteplase also helps if it is given more than 4.5 hours after the stroke. Participants are put into 2 groups randomly, which means by chance. One group gets tenecteplase as a single injection into a vein. The other group receives standard medical practice. Participants have an equal chance of receiving tenecteplase or the standard treatment. Participants are in the study for about 3 months. In the beginning, participants stay in the hospital for about 1 week. During the study, participants have 7 clinical examinations or visits. The last 2 of these visits will likely be done from home, allowing participants to complete certain assessments remotely. Doctors regularly test participants' recovery using a scale that measures the level of disability or dependence in daily activities. The results are compared between the 2 groups to see whether the treatment works. The doctors also check participants' health and take note of any unwanted effects.

Вмешательства

Препарат Tenecteplase
Tenecteplase
Препарат Standard of care treatment
Standard of care treatment

Первичные конечные точки

modified Rankin Scale (mRS) score of 0-1 at Day 90 [Срок оценки: at day 90]

Вторичные конечные точки (6)

mRS (ordinal) at Day 90 [Срок оценки: at day 90]
Early neurological improvement (reduction in acute - 24-hour National Institute of Health Stroke Scale (NIHSS) score of ≥8 or value of 0/1) [Срок оценки: at baseline/randomisation, 24 hours after randomization]
mRS 0-2 at Day 90 [Срок оценки: at Day 90]
Symptomatic intracranial haemorrhage (sICH) as defined by Safety Implementation of Thrombolysis in Stroke: Monitoring Study (SITS-MOST) criteria at 36 h [Срок оценки: after 36 hours]
sICH as defined by European Cooperative Acute Stroke Study (ECASS) III criteria at 36 h [Срок оценки: after 36 hours]
Death from any cause within 90 days [Срок оценки: up to 90 days]

Критерии участия

Критерии включения

Male or female ≥18 years old and at least at the legal age of consent in countries where it is greater than 18 years
Signed and dated written informed consent in accordance with ICH-GCP and local legislation prior to admission to the trial
Acute ischaemic stroke (including wake-up stroke) affecting the supratentorial circulation (anterior cerebral artery (ACA), middle cerebral artery (MCA), and posterior cerebral arteries (PCA)) last known well >4.5 h before time of presumed randomisation
Pre-stroke modified Rankin scale (mRS) ≤1
Imaging eligibility by magnetic resonance imaging (MRI)computed tomography (CT)

Критерии исключения

Intention to proceed to mechanical thrombectomy (MT) at the same site (hospital) of randomisation
Occlusion of the internal carotid artery (ICA)
High-risk patients (increased risk of thrombolysis related hemorrhage)
Any intracranial hemorrhage detected on non-contrast computed tomography (NCCT) or MRI scans
Contra-indication to contrast brain imaging with CT and MRI
Severe stroke as assessed clinically (National Institute of Health Stroke Scale (NIHSS) > 25)
Non-disabling minor stroke symptoms (NIHSS ≤5), or rapidly improving symptoms at the discretion of the investigator
Imaging or clinical findings not indicative of acute ischemic stroke or suggesting stroke older than 72 h
Patients scheduled to receive intravenous (i.v.) thrombolysis as standard of care Further exclusion criteria apply.

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