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STARS
Not yet recruitingPhase 3Efficacy of Semaglutide in Improving Neurological Outcomes After Endovascular Thrombectomy for Acute Ischemic Stroke: A Randomized Double-Blind Controlled Trial
Lead sponsor
Asset
Semaglutide
GLP-1 agonist
Listed sites
1
Recruiting sites
—
Enrollment
436
estimated
Study population
Stroke
Key I/E criterion
—
Primary endpoint
•MRS at 90-days
Footprint
Where this trial recruits
Site locations as reported to ClinicalTrials.gov. Site count is not enrollment count; per-site enrollment is not available from source.
Identifiers
Registered as
Timeline
Milestones
Assets
Investigational agents
Study populations
Who this study enrolls
Eligibility
Who can enroll
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.
Endpoints (4)
What's being measured
Protocol endpoints and posted registry outcome measures, grouped into outcome categories. Composite endpoints show their component event types. Standard codes (LOINC, SNOMED CT) are shown where available.
Coverage by outcome category
Cardiovascular outcomes
1 endpointInfarct volume after 72 hours of treatment
Time frame:72 hours postoperatively
descriptive, improvement
Safety / tolerability / PK
1 endpointthe incidence of surgical complications within 90 days postoperatively
Time frame:within 90 days postoperatively
time to event, event
Other clinical outcomes
2 endpointsmRS at 90-days
Time frame:90 days postoperatively
categorical status, improvement
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.
change from baseline, improvement
Publications (12)
Bibliography
Records linked to this trial through ClinicalTrials.gov references, PubMed NCT search, and curated study seeds. 'Canonical' marks design/result papers; others are registry references or candidates.
Registry references + supporting bibliography
- Journal of neuroinflammation2025 May 27PMID40426210doi:10.1186/s12974-025-03465-9via CT.gov reference
- Reviews in endocrine & metabolic disorders2023 Aug (month)PMID37231200doi:10.1007/s11154-023-09807-3via CT.gov reference
- Seminars in immunopathology2022 Sep (month)PMID35767089doi:10.1007/s00281-022-00943-7via CT.gov reference
- The New England journal of medicine2022 Apr 7PMID35138767doi:10.1056/NEJMoa2118191via CT.gov reference
- British journal of pharmacology2022 Feb (month)PMID34519040doi:10.1111/bph.15683via CT.gov reference
- The Lancet. Neurology2021 Oct (month)PMID34487721doi:10.1016/S1474-4422(21)00252-0via CT.gov reference
- The New England journal of medicine2020 Jul 16PMID32668115doi:10.1056/NEJMcp1917030via CT.gov reference
- The New England journal of medicine2016 Nov 10PMID27633186doi:10.1056/NEJMoa1607141via CT.gov reference
Provenance
Sources
Trial facts come from public ClinicalTrials.gov records. Endpoint categories are Delfa's classification of those records, not a ClinicalTrials.gov field. All figures reflect the July 1, 2026 snapshot.