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Набор скоро начнётся NCT05534360

Tenecteplase Treatment in Ischemic Stroke Registry

Наблюдательное Stroke, Acute

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
Это наблюдательное исследование: исследуемое лечение участникам по протоколу не назначают.
Кому может быть актуально
Состояния в реестре: Stroke, Acute. 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
Франция
Следующий шаг
Сохраните исследование, покажите его лечащему врачу и уточните актуальный статус у исследовательского центра. Расходы, документы и поездка →

Обзор

The Tenecteplase Treatment in Acute Ischemic Stroke (TETRIS) Registry is multicenter ambispective observational study of patients with acute ischemic stroke who received intravenous thrombolysis with Tenecteplase

Подробное описание

Acute ischemic stroke management has considerably evolved over the last 20 years with the development of reperfusion treatments: intravenous thrombolysis (IVT) with alteplase, which is effective for AIS within 4.5 hours from symptoms onset and up to 9 hours in some cases; and mechanical thrombectomy (MT), in AIS with large vessel occlusion (LVO) within 24 hours from symptoms onset, either after IVT (bridging therapy) or alone in case of IVT contra-indication.

Alteplase is a recombinant form of tissue plasminogen activator (rtPA) that, when bound to fibrin, will activate plasminogen and lead to fibrinolysis and clot dissolution. It is administered at a dose of 0.9 mg/kg (maximum 90 mg) with an intravenous bolus (10% of the dose) followed by a one-hour infusion. Tenecteplase is a genetically modified form of alteplase with greater fibrin specificity and a longer half-life, which allows a simpler one bolus administration at a dose of 0.25 mg/kg (maximum 25 mg).

In the Tenecteplase versus Alteplase before Endovascular Therapy for Ischemic Stroke (EXTEND-IA TNK) randomized clinical trial, which compared tenecteplase and alteplase in bridging therapy for AIS with LVO, tenecteplase achieved a better recanalization rate on arteriography before MT and a better functional outcome at 3 months. Following this trial, tenecteplase was added in stroke guidelines as an alternative to alteplase for IVT in bridging therapy. More recently, the Alteplase compared to Tenecteplase (ACT) trial has shown, in patients with LVO and non-LVO AIS, that tenecteplase is non-inferior to alteplase in terms of functional outcome. It is likely that in the near future tenecteplase will be added as an alternative to alteplase for AIS without LVO. However, while some "real-life" studies have been published on tenecteplase use for AIS with LVO, data on the general use of tenecteplase are still scarce.

The Tenecteplase Treatment in Acute Ischemic Stroke (TETRIS) Registry is multicenter ambispective observational study of patients with acute ischemic stroke who received intravenous thrombolysis with Tenecteplase. The main aim of this registry is to provide routine clinical care data on the use of tenecteplase for IVT for both AIS with and without LVO, in order to further characterize the safety and efficacy of tenecteplase for AIS. Additionally, we aim to use this registry which combines clinical and radiological data to explore other aspects related to AIS management in this cohort.

Первичные конечные точки

  • Functional outcome [Срок оценки: Day 90]
Вторичные конечные точки (9)
  • Efficacy on functional independence (mRS ≤ 2) [Срок оценки: Day 90]
  • Mortality rate [Срок оценки: Day 90]
  • Early neurological outcome [Срок оценки: Day 1]
  • Incidence of haemorrhagic transformation [Срок оценки: Day 1]
  • Incidence of symptomatic intracerebral haemorrhage (sICH) [Срок оценки: Day 1]
  • Pre-thrombectomy recanalization rate [Срок оценки: Day 1]
  • Final recanalization rate [Срок оценки: Day 1]
  • Thrombolysis complication rate [Срок оценки: Day 1]
  • Thrombectomy complication rate [Срок оценки: Day 1]

Критерии участия

Критерии включения

  • Age 18 and older
  • Confirmed acute arterial ischemic stroke on brain imaging (CT or MRI) within 270 minutes of symptoms onset or with perfusion CT or MRI criteria for an extended treatment window or wake-up strokes.
  • Intravenous thrombolysis with tenecteplase

Критерии исключения

  • Contra-indication to intravenous thrombolysis
  • Intravenous thrombolysis with alteplase
  • Venous ischemic stroke

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

Здоровые добровольцы: Нет

Дизайн исследования

Модель наблюдения
Когортное

Центры проведения

Франция · 1 центр
  • Service des Urgences Cérébro-Vasculaires, Hôpitaux Universitaires Pitié-Salpêtrière et Sai — Paris

Публикации

  • Gerschenfeld G, Lapergue B, Seners P, Piotin M, Chausson N, Scarcia L, Arquizan C, Costalat V, Olindo S, Marnat G, Guillon B, Bourcier R, Yger M, Allard J, Richard S, Gory B, Pico F, Macian Montoro F, Mounayer C, Ben Hassen W, Venditti L, Caroff J, Clarencon F, Consoli A, Turc G, Alamowitch S; ETIS and TETRIS investigators. IV Tenecteplase Before Thrombectomy Compared With Thrombectomy Alone in Pa PMID 41678809
  • Gerschenfeld G, Turc G, Obadia M, Chausson N, Consoli A, Olindo S, Caroff J, Marnat G, Blanc R, Ben Hassen W, Seners P, Guillon B, Wiener E, Bourcier R, Yger M, Cho TH, Checkouri T, Gory B, Smadja D, Sibon I, Richard S, Piotin M, Eker OF, Pico F, Lapergue B, Alamowitch S; for ETIS and TETRIS study groups. Functional Outcome and Hemorrhage Rates After Bridging Therapy With Tenecteplase or Alteplase PMID 38862134

Идентификаторы

NCT: NCT05534360 · APHP220465

Первоисточники (государственные реестры)

Открыть это исследование на ClinicalTrials.gov ↗