Clinical trial

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

Opening soon · Phase 3 · 0 countries · Registry ID NCT07511543

Opening soonPhase 3Interventional

What this study is about

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 vanguard phase of 100 patients with stroke who are scheduled for EVT in approximately 10 stroke centers across Canada. Once complete the full-scale phase III study of 826 patients (including 100 patients from the vanguard phase) at 52 global stroke centers will start. 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. During the vanguard phase, 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 full trial will establish the benefit of semaglutide to improve the outcomes of patients with LVO treated with EVT.

A promising-looking record is not the same as confirmed eligibility. The study team must review the full criteria and current recruitment status.

Basic eligibility

Age18 Years to Not listed

SexAll

Healthy volunteersNot accepted

ConditionIschemic Stroke

Full registry criteria

Inclusion Criteria: 1. Age 18 years or above on the date of randomization. 2. 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). 3. National Institutes of Health Stroke Scale (NIHSS) ≥ 6 points at the time of randomization. 4. Pre-stroke modified Rankin Scale (mRS) 0 or 1. 5. Ability to randomize within 6 hours from the end of EVT. 6. Capable of giving signed informed consent either independently, or by a legally authorized representative (LAR). Exclusion Criteria: 1. Pregnancy or breast-feeding. 2. Renal insufficiency (creatinine clearance \< 30mL/min). 3. Cirrhosis or severe hepatic dysfunction, characterized by jaundice, encephalopathy or coagulopathy. 4. History of pancreatitis in the year prior to randomization or evidence of acute pancreatitis on randomization. 5. Active sepsis on randomization. 6. 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. 7. Any terminal medical condition with life expectancy of less than 3 months. 8. Personal or family history of medullary thyroid carcinoma (MTC) or patients with multiple endocrine neoplasia syndrome type 2 (MEN 2). 9. Body mass index (BMI) less than 19. 10. Known hypersensitivity to GLP-1 RAs. 11. Active treatment with an GLP-1RA prior to randomization. 12. Refusal or inability to administer subcutaneous (SC) injections by the patient or a caregiver. 13. Close affiliation with the investigational site.

Treatments and study arms

Semaglutide

Drug

Glucagon-like peptide-1 (GLP-1) receptor agonist

Primary outcomes

Vanguard phase: Feasibility - RecruitmentFrom site activation until the end of recruitment (approximately 24 months)

Recruitment of approximately 6 patients per site per year at approximately 10 Canadian stroke centres

Full trial: Functional IndependencFrom randomization to day 90±14

Functional independence at 90±14 days from randomization defined as a modified Rankin Scale (mRS) score of 2 or less.

Study locations

0 locations were listed when this page was built. The first 40 are shown.

No public site location was included in this record. Check the original registry for updates.