Clinical trial

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

Opening soon · Phase 3 · 1 countries · Registry ID NCT07030621

Opening soonPhase 3Interventional

What this study is about

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.

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

ConditionAcute Ischemic Stroke

Full registry criteria

Inclusion Criteria: 1. Clinical or imaging diagnosis of acute ischemic stroke within 24 hours after onset; 2. Scheduled for endovascular thrombectomy; 3. Age ≥18 years; 4. Pre-stroke modified Rankin Scale (mRS) score ≤1; 5. Informed consent voluntarily signed by the patient or legal representative. Exclusion Criteria: 1. Preoperative imaging diagnosis of intracranial hemorrhage, or history of intracranial hemorrhage within 3 months prior to surgery; 2. Contraindications for endovascular thrombectomy; 3. Recent history of ischemic stroke; 4. Fasting blood glucose \<3.9 mmol/L; 5. ASA classification of IV-V; 6. Severe organic heart disease or severe arrhythmia; 7. Pregnant or lactating women; 8. Contraindications to semaglutide or allergy to semaglutide.

Treatments and study arms

Semaglutide 0.5 mg

Drug

Semaglutide is a glucagon-like peptide-1 receptor agonist (GLP-1 RA) analog, which has been found to have neuroprotective effects.

Normal Saline

Drug

Normal saline is the placebo drug.

Primary outcomes

mRS at 90-days90 days postoperatively

The primary endpoint is the degree of disability or dependence at 90 days as assessed by the mRS shift. A global measure of disability, the mRS comprises of seven grades ranging from 0 (no symptoms) to 6 (death). 0-2 points: indicating good neurological function recovery in patients; 3-6 points: indicating poor neurological function recovery in patients.

Study locations

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

Renji Hospital, Shanghai Jiao Tong University School of Medicine🇨🇳 Shanghai, Shanghai Municipality, China

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Peiying Li MD，Ph.DContact

Email · Call 15800616866