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Trial · Interventional

Not yet recruitingPhase 3Registry data

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

Short name STARS

NCTNCT07030621 (opens ClinicalTrials.gov in a new tab)Other id2025-175
Open at ClinicalTrials.govAsk about this trial

Overview

Status
Not yet recruiting
Phase
Phase 3
Enrollment
436 participants (estimated)
Sponsor
RenJi Hospital · Other
Design
Randomized · Double masking
Countries
1 country

China

Start
1 Jul 2025 (estimated)
Primary completion
31 Jul 2027 (estimated)
Completion
31 Jan 2028 (estimated)
First posted
22 Jun 2025
Last update posted
22 Jun 2025
Conditions
Acute Ischemic Stroke

Timeline

1 trial · 1 not yet recruiting

  • Completed
  • Ongoing
  • Not yet recruiting
  • Stopped
  • Estimated dates (est.)
  • Results posted
20252026202720282029
  1. Ph 3

    STARS

    NCT07030621

    est. 1 Jul 2025 to est. 31 Jan 2028

Registry summary

Text and fields below are the sponsor's entries at ClinicalTrials.gov, shown as posted.

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.

Interventions

  • Semaglutide 0.5 mgDrug
  • Normal SalineDrug

Arms2

  • Experimental

    semaglutide group

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

  • Placebo comparator

    placebo group

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

Primary outcomes1

Outcomes the sponsor listed as primary.

  1. mRS at 90-days

    Time frame · 90 days postoperatively

    Registry description

    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(3)

  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.

    Registry description

    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

    Registry description

    assessed by magnetic resonance imaging brain scan

  3. the incidence of surgical complications within 90 days postoperatively

    Time frame · within 90 days postoperatively

Posted results

Values are shown as posted at ClinicalTrials.gov, with their units. PepBank has not converted, pooled or compared them.

No results are posted for this trial.

A trial that is still running, or that stopped early, may post results later.

Registry data comes from ClinicalTrials.gov. Study results come from studies, not from the registry. How PepBank works

Studies4

Studies that cite this trial.

Studies with results

2 studies on this page

Indexing hint: Systematic review · 2023

6 results

Effects of GLP-1 receptor agonists on neurological complications of diabetes.

García-Casares et al. 2023Reviews in endocrine & metabolic disorderscited by 34

PMID 37231200PMC10404567DOI 10.1007/s11154-023-09807-3PUB-37231200

CC BY6 results
Download PDFSee results (6)

Indexing hint: Randomized controlled trial · 2016

8 results

Semaglutide and Cardiovascular Outcomes in Patients with Type 2 Diabetes.

Marso et al. 2016The New England journal of medicinecited by 5,002

PMID 27633186DOI 10.1056/nejmoa1607141PUB-27633186

Rights unknown8 results
Source linkSee results (8)

More studies

2 studies on this page

Indexing hint: Animal study · 2025

Semaglultide targets Spp1+ microglia/macrophage to attenuate neuroinflammation following perioperative stroke.

Li et al. 2025Journal of neuroinflammationcited by 18

PMID 40426210PMC12117698DOI 10.1186/s12974-025-03465-9PUB-40426210

Free to read · publisher termsCC BY-NC-ND
Read at source

Indexing hint: Review · 2022

The role of glia in the physiology and pharmacology of glucagon-like peptide-1: implications for obesity, diabetes, neurodegeneration and glaucoma.

Cui et al. 2022British journal of pharmacologycited by 57

PMID 34519040PMC8820182DOI 10.1111/bph.15683PUB-34519040

Rights unknown
Source link

Other registry references

References listed at the registry that are not in PepBank. They link to PubMed.

  • ResultCandelario-Jalil E, Dijkhuizen RM, Magnus T. Neuroinflammation, Stroke, Blood-Brain Barrier Dysfunction, and Imaging Modalities. Stroke. 2022 May;53(5):1473-1486. doi: 10.1161/STROKEAHA.122.036946. Epub 2022 Apr 7. PMID 35387495
  • ResultDeLong JH, Ohashi SN, O'Connor KC, Sansing LH. Inflammatory Responses After Ischemic Stroke. Semin Immunopathol. 2022 Sep;44(5):625-648. doi: 10.1007/s00281-022-00943-7. Epub 2022 Jun 29. PMID 35767089
  • ResultNie X, Leng X, Miao Z, Fisher M, Liu L. Clinically Ineffective Reperfusion After Endovascular Therapy in Acute Ischemic Stroke. Stroke. 2023 Mar;54(3):873-881. doi: 10.1161/STROKEAHA.122.038466. Epub 2022 Dec 7. PMID 36475464
  • ResultYoshimura S, Sakai N, Yamagami H, Uchida K, Beppu M, Toyoda K, Matsumaru Y, Matsumoto Y, Kimura K, Takeuchi M, Yazawa Y, Kimura N, Shigeta K, Imamura H, Suzuki I, Enomoto Y, Tokunaga S, Morita K, Sakakibara F, Kinjo N, Saito T, Ishikura R, Inoue M, Morimoto T. Endovascular Therapy for Acute Stroke with a Large Ischemic Region. N Engl J Med. 2022 Apr 7;386(14):1303-1313. doi: 10.1056/NEJMoa2118191. Epub 2022 Feb 9. PMID 35138767
  • ResultLansberg MG, Schrooten M, Bluhmki E, Thijs VN, Saver JL. Treatment time-specific number needed to treat estimates for tissue plasminogen activator therapy in acute stroke based on shifts over the entire range of the modified Rankin Scale. Stroke. 2009 Jun;40(6):2079-84. doi: 10.1161/STROKEAHA.108.540708. Epub 2009 Apr 16. PMID 19372447
  • ResultPowers WJ. Acute Ischemic Stroke. N Engl J Med. 2020 Jul 16;383(3):252-260. doi: 10.1056/NEJMcp1917030. No abstract available. PMID 32668115
  • ResultPowers WJ, Rabinstein AA, Ackerson T, Adeoye OM, Bambakidis NC, Becker K, Biller J, Brown M, Demaerschalk BM, Hoh B, Jauch EC, Kidwell CS, Leslie-Mazwi TM, Ovbiagele B, Scott PA, Sheth KN, Southerland AM, Summers DV, Tirschwell DL. Guidelines for the Early Management of Patients With Acute Ischemic Stroke: 2019 Update to the 2018 Guidelines for the Early Management of Acute Ischemic Stroke: A Guideline for Healthcare Professionals From the American Heart Association/American Stroke Association. Stroke. 2019 Dec;50(12):e344-e418. doi: 10.1161/STR.0000000000000211. Epub 2019 Oct 30. PMID 31662037
  • ResultGBD 2019 Stroke Collaborators. Global, regional, and national burden of stroke and its risk factors, 1990-2019: a systematic analysis for the Global Burden of Disease Study 2019. Lancet Neurol. 2021 Oct;20(10):795-820. doi: 10.1016/S1474-4422(21)00252-0. Epub 2021 Sep 3. PMID 34487721

Eligibility

Who could join, as posted.

Sex
All
Age
from 18 Years
Healthy volunteers
Not accepted
Inclusion and exclusion criteria, as posted
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.

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