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NCT07511543Toborzás még nem indult2. fázis

Glucagon-like Peptide-1 Receptor Agonists for Endovascular Stroke Thrombectomy

A Multicentre, Prospective, Randomized, Open-label, Blinded Endpoint, Pilot Clinical Trial Evaluating Subcutaneous Semaglutide in Patients With Acute Ischaemic Stroke Due to Anterior Circulation Large Vessel Occlusion Treated With Endovascular Thrombectomy

Forrás: ClinicalTrials.gov · Utoljára frissítve: 2026. szept. 24.

Rövid összefoglaló (regiszter, angolul)

Endovascular thrombectomy (EVT) is a procedure that improves recovery for people who suffer from a stroke by removing blood clots from large blood vessels in the brain. However, even with this treatment, over half of the patients either pass away or are left with serious disabilities within three months. This is partly because, even in cases of a successful EVT, brain tissue damage continues to grow. Extent of brain damage is a major factor in how well a patient recovers. Studies in animals have shown that a drug called semaglutide might help protect the brain and improve recovery after a stroke. Semaglutide is currently used for the treatment of diabetes and obesity and is given as a weekly injection under the skin. The investigators are hoping to test whether giving semaglutide to stroke patients undergoing EVT can improve their recovery. A very large study at many hospitals is needed to answer this question. The investigators are starting with a smaller study to gain information on whether it is possible to perform a larger definitive one, and if so, how best to plan for it. In this first step we will study 100 patients with stroke who are scheduled for EVT in approximately 10 stroke centers across Canada. These patients will be randomly divided (like flipping a coin) into two groups: one will receive weekly semaglutide injections for 12 weeks, while the other will not receive the drug. The investigators will track how many patients agree to participate, how many stay in the study, and how well they follow the treatment plan. The investigators will also monitor the patients' recovery, overall health, and any side effects from the treatment. These results will provide important information to plan our larger study with the goal of reducing death rates and long-term disability in stroke patients undergoing EVT.

Állapot (regiszter)
Toborzás még nem indult
Fázis (regiszter)
2. fázis
Vizsgálattípus
Beavatkozással járó
Résztvevők száma
100 (tervezett)
Első benyújtás
2026. márc. 30.
Kezdés
2026. okt. 31.
Elsődleges befejezés
2028. okt. 31.
Fő szponzor
Population Health Research Institute
NCT-szám
NCT07511543

Mit vállalsz

  • Vizsgálat típusa: Beavatkozással járó · 2. fázis
  • Tervezett résztvevők: 100
  • 2026. okt. 31. és az elsődleges befejezés (2028. okt. 31.) között
  • Nincs megadott helyszín, ország nélkül
  • Vizitek és vizsgálatok: kérdezd a vizsgálat csapatát, a regiszter nem sorolja fel őket

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Korábbi kezelés

  • History of pancreatitis in the year prior to randomization or evidence of acute pancreatitis on randomization.
  • Active treatment with an GLP-1RA prior to randomization.

Más betegség

  • Cancer, regionally advanced or metastatic, or for which treatment had been administered within 6 months from randomization, or hematological cancer that is not in complete remission.
  • Any terminal medical condition with life expectancy of less than 3 months.
  • Personal or family history of medullary thyroid carcinoma (MTC) or patients with multiple endocrine neoplasia syndrome type 2 (MEN 2).
  • Known hypersensitivity to GLP-1 RAs.

Laborértékek

  • Renal insufficiency (creatinine clearance < 30mL/min).

Egyéb

  • Pregnancy or breast-feeding.
  • Cirrhosis or severe hepatic dysfunction, characterized by jaundice, encephalopathy or coagulopathy.
  • Active sepsis on randomization.
  • Body mass index (BMI) less than 19.
  • Refusal or inability to administer subcutaneous (SC) injections by the patient or a caregiver.
  • Close affiliation with the investigational site.

Kiket keres a vizsgálat

  • Age 18 years or above on the date of randomization.
  • EVT for an LVO in the anterior circulation, defined as the intracranial segment of the internal carotid artery (ICA) and/or the M1 or proximal M2 segment of the middle cerebral artery (MCA).
  • National Institutes of Health Stroke Scale (NIHSS) ≥ 6 points at the time of randomization.
  • Pre-stroke modified Rankin Scale (mRS) 0 or 1.
  • Ability to randomize within 6 hours from the end of EVT.
  • Capable of giving signed informed consent either independently, or by a legally authorized representative (LAR).

Életkor a regiszterben: 18 év – - · Nem: nők és férfiak · Egészséges önkénteseket nem fogad

A teljes feltétellista: ClinicalTrials.gov

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