Unknown Time of Onset Stroke RePerfusIon Without Advanced Imaging

Официальное название

Intravenous Tenecteplase for Acute Ischemic Stroke With Unknown Time of Onset Under Non-Contrast CT Selection: A Multicenter, Prospective, Randomized, Open-label, Blinded Endpoint Trial

Обзор

The benefit of intravenous tenecteplase for acute ischemic stroke with unknown time of onset, e.g. wake-up stroke, remains uncertain. This randomized study aims to assess the efficacy and safety of intravenous tenecteplase following non-contrast CT screening for acute ischemic stroke with unknown time of onset.

Подробное описание

UTOPIA is an investigator-initiated, multicenter, prospective, randomized, open-label, blinded endpoint (PROBE) trial that aims to assess the efficacy and safety of intravenous tenecteplase for acute ischemic stroke with unknown time of onset, selected by non-contrast CT. The primary outcome is excellent outcome, as defined by a score of 0 or 1 on modified Rankin Scale (mRS) at 90 days.

Participants randomized to the intervention group will receive intravenous tenecteplase at 0.25 mg/kg with a maximum dose of 25 mg and standard medical treatment, and those randomized to the control group will receive standard medical treatment only, without intravenous thrombolysis.

Вмешательства

• Препарат Tenecteplase (TNK) (0.25 mg/kg, to maximum of 25mg)
  Tenecteplase is administered as a single intravenous bolus at a dose of 0.25 mg/kg, with a maximum of 25 mg, administered as soon as possible after the randomization.
• Другое Standard medical treatment
  Standard medical treatment should adhere to clinical guidelines and usual care at site, including antiplatelet therapy, anticoagulant therapy, lipid-lowering therapy, antihypertensive drugs, etc., as determined by the local investigators.

Первичные конечные точки

• Excellent outcome [Срок оценки: 90 (±14) days]

Вторичные конечные точки (5)

• Level of disability [Срок оценки: 90 (±14) days]
• Functional independence [Срок оценки: 90 (±14) days]
• Early neurological improvement [Срок оценки: 24 (±12) hours]
• Change in stroke severity [Срок оценки: 7 (±1) days or at discharge]
• Quality of life measured by EQ-5D-5L [Срок оценки: 90 (±14) days]

Критерии участия

Критерии включения

• Age ≥ 18 years old.
• Clinical diagnosis of acute ischemic stroke.
• Unknown time of stroke onset (e.g., stroke symptom recognized on awakening) but last-known normal time >4.5 hours.
• Time from stroke symptom recognition (e.g., awakening) to randomization within 3 hours.
• National Institutes of Health Stroke Scale (NIHSS) score of 6-25 (both inclusive).
• Pre-stroke modified Rankin Scale (mRS) score of 0-1.
• Written informed consent from patients or their legally authorized representatives.

Критерии исключения

• Intracranial hemorrhage confirmed by skull CT, or history of intracranial hemorrhage.
• Rapid neurological improvement with NIHSS <6 at randomization.
• Allergy to tenecteplase.
• Use of vitamin K antagonist with INR >1.7, use of heparin or low molecular heparin in the past 24 hours, or use of direct oral anticoagulants in the past 48 hours.
• Hypodensity on non-contrast CT >1/3 middle cerebral artery territory.
• Severe traumatic brain injury or other major trauma in the past 3 months.
• Intracranial neoplasm, arteriovenous malformation, or aneurysm (≥10mm).
• Intracranial surgery, intraspinal surgery, or other major surgery in the past 3 months.
• Gastrointestinal or urinary tract hemorrhage in the past 3 weeks.
• Active internal bleeding.
• Aortic dissection.
• Infective endocarditis.
• Platelet count <100×10\^9/L.
• Women who are pregnant or breastfeeding.
• Blood glucose <50 or >400 mg/dL (<2.78 or >22.2 mmol/L).
• Systolic blood presure >185 mmHg or diastolic blood presure >110 mmHg refractory to treatment.
• Life expectancy <3 months.
• Participating in other trials.
• Any condition that, in the judgment of the investigator, makes the patient unsuitable for this study or where this study may impose a significant risk to the patient (e.g., inability to understand and/or comply with study procedures and/or follow-up due to psychiatric disorders, cognitive or emotional impairment).

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

Простое слепое

Основная цель

Лечение

Центры проведения

Китай · 1 центр

• The First Affiliated Hospital of Guangxi Medical University — Nanning

Идентификаторы

NCT: NCT07475949 · 2026-K0007

Первоисточники (государственные реестры)

• ClinicalTrials.gov (NIH, США)

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