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NCT05920889CompletedPhase 2

Glucagon-like Peptide 1 Receptor Agonist in Acute Large Vessel Occlusion Stroke Treated by Reperfusion Therapies

Glucagon-like Peptide 1 Receptor Agonist in Acute Large Vessel Occlusion Stroke Treated by Reperfusion Therapies - a Pilot Study

Source: ClinicalTrials.gov · Last updated 7 Mar 2025

Brief summary (registry, in English)

Endovascular thrombectomy (EVT) is a highly effective therapy for acute ischemic stroke with large vessel occlusion (LVO). EVT was proven efficacious in selected patients with symptoms onset or last-known-well time of up to 24 hours. With a number-needed-to-treat (NNT) of 2.3-2.8 to achieve functional independence, EVT had become the current state-of-the-art treatment for ischemic stroke with LVO. Nevertheless, more than half of LVO strokes suffered from functional dependence or death despite EVT. Futile EVTs were contributed by peri-procedural malignant brain edema (MBE) and symptomatic intracranial hemorrhage (sICH). Studies suggested that 26.9% of EVTs were complicated by MBE, whereas sICH was present in 6-9% of LVO patients who received EVT. The fundamental pathophysiology of MBE and sICH is blood-brain-barrier (BBB) disruption secondary to ischemia, mechanical and reperfusion injury. These pathological processes can result in increased tissue permeability, excess production of oxygen free radicals and inflammatory response that eventually lead to hemorrhage and edema. Poor collateral circulation, proximal LVOs, intravenous thrombolysis, blood pressure and glucose fluctuation had all been implicated to in MBE and sICH. However, these risk factors were either unmodifiable or not shown to improve EVT outcomes. The preliminary results of a recent randomized trial even suggested harmful effects of intensive blood pressure following EVT. With indications of EVT are expanding to patients with prolonged ischemia and large ischemic cores, enhancing BBB and neuronal tolerance to ischemia and reperfusion therapies may hugely impact on EVT outcomes. Recent animal models have shown that glucagon-like peptide peptide-1 receptor agonists (GLP-1RA) significantly reduced infarct volume and neurological deficits following temporary or permanent middle cerebral artery occlusion. These effects were likely due to the anti-oxidant, anti-inflammatory and anti-apoptotic properties of GLP-1RA that protected BBB integrity and ischemic neurons during induced LVO and/or reperfusion. Investigator hypothesizes that compared to standard reperfusion strategies, administration of GLP-1RA in LVO patients who receive EVT may prevent the development of MBE and sICH, and improve neurological outcomes. In this randomized, open-label pilot study, investigator aims to determine the effect of semaglutide, a GLP-1RA, on the radiological and clinical outcomes in LVO patients undergoing EVT.

Status (registry)
Completed
Phase (registry)
Phase 2
Study type
Interventional
Enrollment
140 (actual)
First submitted
16 Jun 2023
Start date
1 Aug 2023
Primary completion date
25 Oct 2024
Lead sponsor
Chinese University of Hong Kong
Diseases
Stroke
NCT number
NCT05920889

What you commit to

  • Study type: Interventional · Phase 2
  • Participants enrolled: 140
  • From 1 Aug 2023 to the primary completion date, 25 Oct 2024
  • 2 sites in 2 countries
  • Visits and tests: ask the trial team, the registry does not list them

Built from the registry fields of ClinicalTrials.gov. It describes the study, not your situation.

Who cannot take part

Copied verbatim from ClinicalTrials.gov and grouped by topic. Only the trial team decides who can take part.

Prior treatment

  • Participation in another clinical trial investigating a drug, medical device, or a medical procedure in the 30 days preceding trial inclusion.
  • Patient already on GLP-1RA prior to screening.

Other illness

  • Intracranial hemorrhage on pre-EVT imaging.
  • LVO etiologies other than thromboembolism or intracranial stenosis (acute or acute on chronic total occlusion), e.g. arterial dissection, infective endocarditis on initial diagnostic imaging.Estimated or known body mass index \< 18 kg/m2
  • Severe or fatal comorbid illness, e.g. terminal malignancy.
  • History of allergy to GLP-1RA.
  • Family or personal history of multiple endocrine neoplasia, medullary thyroid carcinoma, pancreatic carcinoma, known proliferative diabetic retinopathy.
  • Patients prone to severe hypoglycaemia, including chronic kidney disease of estimated glomerular filtration rate of 50ml/min/1.73m\^2; also those with chronic liver disease with Child's Pugh score C or above; patients with recurrent unexplained hypoglycemia.

Lab values

  • Pregnancy/Lactation; female, with positive urine or serum beta human chorionic gonadotropin (β-hCG) test, or breastfeeding.
  • Creatinine clearance \< 30mL/min.
  • Patients with hypoglycaemia on presentation. Defined as capillary or serum glucose level of \<4mmol/L.

Other

  • ASPECT score ≤ 5.
  • Estimated or known body mass index \< 18 kg/m2.
  • Active sepsis on randomization.
  • Contraindications to iodine-based CT contrast.

Who the study is looking for

  • LVO stroke at terminal ICA or proximal M1 eligible for emergency endovascular treatment as per current treatment guideline.
  • LKW-to-puncture time ≤ 12 hours.
  • Age 18 years or greater.
  • National Institute of Health Stroke Scale (NIHSS) ≥10
  • LVO stroke due to thromboembolism or intracranial stenosis (acute or acute on chronic occlusion).
  • Patients who received computer tomographic angiography and perfusion (CTA+P).
  • Pre-stroke (24 hours prior to stroke onset) independent functional status with modified Rankin Scale (mRS) ≤ 2.
  • Consent process completed as per national laws and regulation and the applicable ethics committee requirements.

Age in the registry: 18 years to 100 years · Sex: All · Does not accept healthy volunteers

Full criteria on ClinicalTrials.gov

Sites (2)

Sites in registry order. Pick your city on the disease page to sort them by distance.

SiteCityCountrySite status
Linyi People's Hospital
Coordinator of this site? Confirm its status
LinyiChinaUnknown status
Chinese University of Hong Kong
Coordinator of this site? Confirm its status
Hong KongHong Kong SAR ChinaUnknown status

This page is information, not medical advice. Discuss any trial with your doctor.