NCT05920889Befejeződött2. fázis
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
Forrás: ClinicalTrials.gov · Utoljára frissítve: 2025. márc. 7.
Rövid összefoglaló (regiszter, angolul)
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.
- Állapot (regiszter)
- Befejeződött
- Fázis (regiszter)
- 2. fázis
- Vizsgálattípus
- Beavatkozással járó
- Résztvevők száma
- 140 (tényleges)
- Első benyújtás
- 2023. jún. 16.
- Kezdés
- 2023. aug. 1.
- Elsődleges befejezés
- 2024. okt. 25.
- Fő szponzor
- Chinese University of Hong Kong
- Betegségek
- Stroke (szélütés)
- NCT-szám
- NCT05920889
Mit vállalsz
- Vizsgálat típusa: Beavatkozással járó · 2. fázis
- Bevont résztvevők: 140
- 2023. aug. 1. és az elsődleges befejezés (2024. okt. 25.) között
- 2 helyszín, 2 országban
- Vizitek és vizsgálatok: kérdezd a vizsgálat csapatát, a regiszter nem sorolja fel őket
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Korábbi kezelés
- 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.
Más betegség
- 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.
Laborértékek
- 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.
Egyéb
- ASPECT score ≤ 5.
- Estimated or known body mass index < 18 kg/m2.
- Active sepsis on randomization.
- Contraindications to iodine-based CT contrast.
Kiket keres a vizsgálat
- 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.
Életkor a regiszterben: 18 év – 100 év · Nem: nők és férfiak · Egészséges önkénteseket nem fogad
Helyszínek (2)
Helyszínek a regiszter sorrendjében. Ha a profilodba mented a városodat, távolság szerint rendeződnek.
| Helyszín | Város | Ország | Helyszín állapota |
|---|---|---|---|
| Linyi People's Hospital | Linyi | Kína | Ismeretlen állapot |
| Chinese University of Hong Kong | Hong Kong | Hongkong | Ismeretlen állapot |
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