Efficacy of Semaglutide in Improving Neurological Outcomes After Endovascular Thrombectomy for Acute Ischemic Stroke: A Randomized Double-Blind Controlled Trial

Обзор

The trial will be a randomized, double-blind, controlled, single-center trial. The purpose of this trial is to determine the efficacy and safety of semaglutide in improving neurological outcomes after endovascular thrombectomy for acute ischemic stroke. The patients in the treatment group will receive a subcutaneous injection of 0.5 mg semaglutide into the abdomen during endovascular thrombectomy. The patients in the control group will receive a similar-looking placebo. Patients will be randomized to the treatment or control group by the pharmacy, eliminating the selection bias. The patient and evaluator will be blind to the allocation of patients, further minimizing the bias.

Подробное описание

Acute ischemic stroke (AIS) is a condition associated with high rates of disability and mortality worldwide, and its incidence continues to rise in our country. Endovascular thrombectomy (EVT), a major advance in stroke treatment in recent years, has gained widespread clinical application and become a standard treatment for AIS caused by large-vessel occlusion. EVT significantly improves neurological functional outcomes. However, in clinical practice, despite successful recanalization of the occluded artery, nearly half of patients do not achieve a favorable prognosis. There is a compelling need to identify novel neuroprotective strategies to enhance the effectiveness of EVT and improve patient quality of life.

Recent evidence indicates that semaglutide reduces neuroinflammation and is associated with a decreased risk of stroke and fewer neurological complications in patients with diabetes. We anticipate that this trial will provide valuable insights into the potential role of semaglutide as a neuroprotective agent in patients with ischemic stroke.

Вмешательства

• Препарат Semaglutide 0.5 mg
  Semaglutide is a glucagon-like peptide-1 receptor agonist (GLP-1 RA) analog, which has been found to have neuroprotective effects.
• Препарат Normal Saline
  Normal saline is the placebo drug.

Первичные конечные точки

• mRS at 90-days [Срок оценки: 90 days postoperatively]

Вторичные конечные точки (3)

• National Institute of Health Stroke Scale (NIHSS) at 24 hours and 7-days [Срок оценки: A decrease of ≥8 points in the NIHSS score from baseline to 24 hours and 7 days postoperatively, or a score of 0 to 1, indicates neurological improvement; an increase of ≥4 points indicates neurological deterioration.]
• Infarct volume after 72 hours of treatment [Срок оценки: 72 hours postoperatively]
• the incidence of surgical complications within 90 days postoperatively [Срок оценки: within 90 days postoperatively]

Критерии участия

Критерии включения

• Clinical or imaging diagnosis of acute ischemic stroke within 24 hours after onset;
• Scheduled for endovascular thrombectomy;
• Age ≥18 years;
• Pre-stroke modified Rankin Scale (mRS) score ≤1;
• Informed consent voluntarily signed by the patient or legal representative.

Критерии исключения

• Preoperative imaging diagnosis of intracranial hemorrhage, or history of intracranial hemorrhage within 3 months prior to surgery;
• Contraindications for endovascular thrombectomy;
• Recent history of ischemic stroke;
• Fasting blood glucose <3.9 mmol/L;
• ASA classification of IV-V;
• Severe organic heart disease or severe arrhythmia;
• Pregnant or lactating women;
• Contraindications to semaglutide or allergy to semaglutide.

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

Двойное слепое

Основная цель

Лечение

Центры проведения

Китай · 1 центр

• Renji Hospital, Shanghai Jiao Tong University School of Medicine — Шанхай

Публикации

• Garcia-Casares N, Gonzalez-Gonzalez G, de la Cruz-Cosme C, Garzon-Maldonado FJ, de Rojas-Leal C, Ariza MJ, Narvaez M, Barbancho MA, Garcia-Arnes JA, Tinahones FJ. Effects of GLP-1 receptor agonists on neurological complications of diabetes. Rev Endocr Metab Disord. 2023 Aug;24(4):655-672. doi: 10.1007/s11154-023-09807-3. Epub 2023 May 26. PMID 37231200
• Marso SP, Bain SC, Consoli A, Eliaschewitz FG, Jodar E, Leiter LA, Lingvay I, Rosenstock J, Seufert J, Warren ML, Woo V, Hansen O, Holst AG, Pettersson J, Vilsboll T; SUSTAIN-6 Investigators. Semaglutide and Cardiovascular Outcomes in Patients with Type 2 Diabetes. N Engl J Med. 2016 Nov 10;375(19):1834-1844. doi: 10.1056/NEJMoa1607141. Epub 2016 Sep 15. PMID 27633186
• Cui QN, Stein LM, Fortin SM, Hayes MR. The role of glia in the physiology and pharmacology of glucagon-like peptide-1: implications for obesity, diabetes, neurodegeneration and glaucoma. Br J Pharmacol. 2022 Feb;179(4):715-726. doi: 10.1111/bph.15683. Epub 2021 Nov 23. PMID 34519040
• Li Y, Fan Q, Pang R, Cai L, Qi J, Chen W, Zhang Y, Chen C, Yu W, Li P. Semaglultide targets Spp1+ microglia/macrophage to attenuate neuroinflammation following perioperative stroke. J Neuroinflammation. 2025 May 27;22(1):143. doi: 10.1186/s12974-025-03465-9. PMID 40426210
• Candelario-Jalil E, Dijkhuizen RM, Magnus T. Neuroinflammation, Stroke, Blood-Brain Barrier Dysfunction, and Imaging Modalities. Stroke. 2022 May;53(5):1473-1486. doi: 10.1161/STROKEAHA.122.036946. Epub 2022 Apr 7. PMID 35387495
• DeLong JH, Ohashi SN, O'Connor KC, Sansing LH. Inflammatory Responses After Ischemic Stroke. Semin Immunopathol. 2022 Sep;44(5):625-648. doi: 10.1007/s00281-022-00943-7. Epub 2022 Jun 29. PMID 35767089
• Nie X, Leng X, Miao Z, Fisher M, Liu L. Clinically Ineffective Reperfusion After Endovascular Therapy in Acute Ischemic Stroke. Stroke. 2023 Mar;54(3):873-881. doi: 10.1161/STROKEAHA.122.038466. Epub 2022 Dec 7. PMID 36475464
• Yoshimura S, Sakai N, Yamagami H, Uchida K, Beppu M, Toyoda K, Matsumaru Y, Matsumoto Y, Kimura K, Takeuchi M, Yazawa Y, Kimura N, Shigeta K, Imamura H, Suzuki I, Enomoto Y, Tokunaga S, Morita K, Sakakibara F, Kinjo N, Saito T, Ishikura R, Inoue M, Morimoto T. Endovascular Therapy for Acute Stroke with a Large Ischemic Region. N Engl J Med. 2022 Apr 7;386(14):1303-1313. doi: 10.1056/NEJMoa2118191. PMID 35138767

Идентификаторы

NCT: NCT07030621 · 2025-175

Первоисточники (государственные реестры)

• ClinicalTrials.gov (NIH, США)

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