Tenecteplase vs Medical Management in 4.5-24h LVO no Access to EVT

Официальное название

Tenecteplase vs Medical Management in 4.5-24h Anterior Circulation Large Vessel Occlusion With no Access to EVT

Обзор

The goal of this clinical trial is to learn if tenectplase works to acute ischemic stroke (AIS) with onset 4.5-9 hours. It will also learn about the safety of tenectplase in AIS with onset 4.5-9 hours. The main question it aims to answer is: Does tenectplase improve the 90-days functional outcome in participants with acute large vessel occlusion? Researchers will compare tenectplase thrombolysis to non-use to see if tenectplase works to improve the functional outcome in participants with onset 4.5-9 hours. Participants will:\* Receive 0.25mg/kg (max 25mg) tenectplase at admission (after randomization) .\* Receive neurological assessment at admission, Day 5-7 or on hospital discharge (whichever earlier). Audio or video of the assessment may be recorded if possible.\* Receive brain CT + CT angiogram + CT perfusion and MRI after randomization, where the CT scan may be repetitive.

Вмешательства

• Препарат TNK
  a dose of 0.25 mg/kg (max 25 mg) administered as a bolus
• Препарат Standard medical treatment
  antiplatelet drugs, anticoagulation or combinations of these treatment modality according to national and institutional guidelines.

Первичные конечные точки

• Proportion of patients with functional independence outcome (mRS 0-2) at day 90 [Срок оценки: 90 days after procedure]

Вторичные конечные точки (5)

• The ordinal shift of modified Rankin Scale [Срок оценки: 90 days after procedure]
• Proportion of patients with functional independence outcome (mRS 0-1) at day 90 [Срок оценки: 90 days after procedure]
• Recanalization of occlusion site according to the arterial occlusive lesion (AOL) scale [Срок оценки: 24 hours after randomization]
• Change in Neurological Function of Participants Assessed by National Institute of Health Stroke Scale [Срок оценки: Baseline and 7-days after randomization (or at discharge)]
• Symptomatic intracranial hemorrhage (SICH) as defined by the Heidelberg Bleeding Classification [Срок оценки: within 36 hours after randomization]

Критерии участия

Критерии включения

• Age 18 years or greater
• Acute ischemic stroke presenting in the 4.5 to 24 hour window from last seen well (including wake-up stroke and no witness stroke).
• Prestroke mRS 0-2
• NIHSS 6 to 25
• Aspect ≥ 7
• ICA terminus, M1, dominant M2 occlusion on CTA or MRA
• Clinical-imaging mismatch assessed by investigator
• Patients with no access to EVT at the time of randomization

Критерии исключения

• Current or past history of significant bleeding over the past 6 months;
• History of intracranial hemorrhage (including possible subarachnoid hemorrhage or subarachnoid hemorrhage due to an aneurysm) or evidence or suspected intracranial hemorrhage;
• Known bleeding tendency;
• Recent severe or dangerous bleeding, or active ulcerative gastrointestinal disease;
• History of central nervous system injury (e.g., intracranial tumor, aneurysm, or arteriovenous malformation, intracranial or spinal surgery), or recent head injury；
• Tumors that increase risk of bleeding;
• Severe liver dysfunction, including liver failure, cirrhosis, portal hypertension (esophageal varices), and active hepatitis;
• Know arterial / venous malformation or aneurysm;
• Bacterial endocarditis, pericarditis, or acute pancreatitis;
• Patients receiving effective anticoagulant therapy (vitamin K antagonists with INR > 1.3, or other oral anticoagulants exceeding the upper limit of the corresponding standard range);
• Heparin use within the past 48 hours and prothrombin time exceeding the upper limit of the standard range;
• Over the past 3 months, undergone major surgery, organ biopsy, or suffered a serious injury;
• Over the past 2 weeks, receiving prolonged ( >2 minutes) cardiopulmonary resuscitation, childbirth, or non-stressful vascular puncture (such as subclavian or jugular vein puncture);
• Stroke episode occurred with epileptic seizure;
• History of stroke comorbid with diabetes;
• History of stroke over the past 3 months；
• Acute bleeding tendency, including platelet count below 100×10⁹/L or other conditions;
• SBP >185 mmHg or DBP >110 mmHg, or requiring intensive treatment (intravenous antihypertensive drugs) to lower blood pressure to within limits;
• Blood glucose <2.8 mmol/L or >22.2 mmol/L (<50 mg/dL or >400 mg/dL)；
• Patient life expectancy of less than 1 year;
• Simultaneous occlusion of multiple blood vessels, defined as bilateral MCAs or MCAs combined with the basilar artery;
• Pregnant women or nursing mothers；
• Patients with a low likelihood of 3-month follow-up；
• Over the past 3 months participated in other interventional clinical trials.

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 University of Science and Technology of China — Хэфэй

Идентификаторы

NCT: NCT07168278 · 2025KY348

Первоисточники (государственные реестры)

• ClinicalTrials.gov (NIH, США)

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