Glucagon-like Peptide 1 Receptor Agonist in Acute Large Vessel Occlusion Stroke After Endovascular Treatment

Обзор

The goal of this clinical trial is to learn if semaglutide works to treat acute ischemic stroke (AIS). It will also learn about the safety of semaglutide in AIS. The main question it aims to answer is: Does semaglutide improve the 90-days functional outcome in participants with acute large vessel occlusion who receive the endovascular treatment (EVT)? Researchers will compare semaglutide injection to non-injection to see if semaglutide works to improve the functional outcome in participants with EVT. Participants will: * Receive 0.5mg semaglutide injection before (Day 0) and 1 week (Day 7) after EVT , or EVT alone. * Have additional blood test before and after EVT. * Receive neurological assessment before EVT, Day 1, Day 3, Day 5-7 after EVT or on hospital discharge (whichever earlier), Day 90±14 after EVT. Audio or video of the assessment may be recorded if possible. * Receive brain CT + CT angiogram + CT perfusion and MRI after EVT, where the CT scan may be repetitive.

Вмешательства

• Препарат Semaglutide 0.5 mg
  0.5mg semaglutide injection before and 1 week after endovascular treatment.
• Другое Standard medical treatment
  Standard medical management

Первичные конечные точки

• The ordinal shift of modified Rankin Scale [Срок оценки: 90±14 days after procedure]

Вторичные конечные точки (6)

• Proportion of patients with functional independence outcome (mRS 0-1) at day 90 [Срок оценки: 90±14 days after procedure]
• Proportion of patients with functional independence outcome (mRS 0-2) at day 90 [Срок оценки: 90±14 days after procedure]
• Proportion of patients with ambulatory and self-care capable outcome (mRS 0-3) at day 90 [Срок оценки: 90±14 days after procedure]
• Neurological Function of Participants Assessed by National Institute of Health Stroke Scale [Срок оценки: Day 1, Day 3, Day 5-7 after EVT (or at discharge, when the patient is discharged on day 5-7)]
• Health-related Quality of Life of Participants Assessed by EuroQol-5 Dimension-5 Level [Срок оценки: 90±14 days after endovascular treatment]
• Activities of Daily Living of Participants Assessed by Bathel Index [Срок оценки: 90±14 days after procedure]

Критерии участия

Критерии включения

• LVO stroke at terminal ICA, M1 or dominant M2 with an LKW-to-randomization ≤24 hours
• Age ≥ 18 years old
• National Institute of Health Stroke Scale ≥ 6 at the time of brain imaging
• Acute LVO stroke due to thromboembolism or intracranial stenosis
• Patients who received computer tomographic or magnetic resonance angiography
• ASPECTS ≥ 6 for patients with LKW-to-randomization ≤6 hours
• Salvageable ischemic penumbra demonstrated by CT perfusion or MRI for patients with LKW-to-randomization between 6 and 24 hours
• Informed consent obtained from patient or acceptable patient surrogate.

Критерии исключения

• Use of intravenous thrombolytic therapy (alteplase or tenecteplase)
• Pre-stroke mRS > 2 for patients <80 years and > 1 for patients ≥ 80 years old
• Intracranial hemorrhage or brain tumour on initial imaging (except small meningiomas)
• Simultaneous occlusion of bilateral anterior circulation, or both anterior and posterior circulation
• Unstable hemodynamics on presentation that require resuscitation
• Systolic blood pressure >185mmHg or diastolic blood pressure >110mmHg that cannot be controlled by antihypertensive drugs
• Severe comorbid illness, e.g. terminal malignancy with life expectancy <1 year
• Pregnant or lactating female
• Participation in another clinical trial
• Contraindications to GLP1-RA, including history of allergy to GLP-1RA, family or personal history of multiple endocrine neoplasia, medullary thyroid or pancreatic carcinoma, or proliferative diabetic retinopathy
• Blood glucose <2.7 or > 22.2 mmol/L; platelet count <50x10\^9 /L; INR >1.7
• Patients with known estimated glomerular filtration rate of <30ml/min/1.73m2 or creatinine >3mg/dL (265.2µmol/L); chronic liver disease with Child's Pugh score C or above; or recurrent unexplained hypoglycemia.
• Suspected or confirmed vasculitis of the central nervous system
• Unable to complete 90-day follow-up assessment

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: NCT06788626 · GALLOP2

Первоисточники (государственные реестры)

• ClinicalTrials.gov (NIH, США)

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