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

Shanghai Jiao Tong University

Status and phase: Not yet enrolling; Phase 3

Conditions: Acute Ischemic Stroke

Treatments: Drug: Normal Saline; Drug: Semaglutide 0.5 mg

Study type: Interventional

Funder types: Other

Identifiers

NCT07030621

2025-175

Details and patient eligibility

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.

Full description

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.

Enrollment: 436 estimated patients

Sex: All

Ages: 18+ years old

Volunteers: No Healthy Volunteers

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.

Trial design

Primary purpose: Treatment

Allocation: Randomized

Interventional model: Parallel Assignment

Masking: Double Blind

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436 participants in 2 patient groups, including a placebo group

semaglutide group

Experimental group

Description:

The patients will receive a subcutaneous injection of 0.5 mg semaglutide into the abdomen during endovascular thrombectomy

Treatment:

Drug: Semaglutide 0.5 mg

placebo group

Placebo Comparator group

Description:

The patients in the control group will receive a similar-looking Normal Saline

Treatment:

Drug: Normal Saline