Skip to main content
OpenTrials
Not Yet Recruiting

NCT Number: NCT07030621

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

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.

Not Yet Recruiting

Trial opening soon.

Get Notified

Key information

Age range

18 year and older

Sex eligibility

All sexes

Study type

Interventional

Phase

Phase 3

Primary location

Renji Hospital, Shanghai Jiao Tong University School of Medicine

Shanghai, Shanghai Municipality, 200127, China

Location contact

Peiying Li MD,Ph.D

CONTACT

[email protected]

15800616866

About this study

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.

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

Inclusion criteria

  • 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.

Exclusion criteria

  • 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.

Treatment and study plan

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

  1. mRS at 90-days

    Time frame: 90 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.

Secondary outcomes

  1. National Institute of Health Stroke Scale (NIHSS) at 24 hours and 7-days

    Time frame: 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.

    NIHSS at 24 hours and 7-days will be recorded based on the patient's neurologic status by a health care professional to assess stroke severity post-procedure.

  2. Infarct volume after 72 hours of treatment

    Time frame: 72 hours postoperatively

    assessed by magnetic resonance imaging brain scan

  3. the incidence of surgical complications within 90 days postoperatively

    Time frame: within 90 days postoperatively

Study contacts

Contact information is provided by the study sponsor or research team.

Peiying Li MD,Ph.D

CONTACT

[email protected]

+8615800616866

Sponsors and collaborators

Lead sponsor

RenJi Hospital

Other

Registry information

Acronym: STARS

Important dates

Study start
2025
Primary completion
2027
Study completion
2028
First posted
Jun 22, 2025
Registry last updated
Jun 22, 2025

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

Published trials that share one or more normalized conditions with this study.