[{"data":1,"prerenderedAt":-1},["ShallowReactive",2],{"health-study-detail:100575853":3},{"organization":4,"armGroups":7,"interventions":21,"overallOfficials":40,"centralContacts":45,"locations":53,"responsibleParty":67,"collaborators":34,"id":70,"slug":71,"hasResults":72,"nctId":73,"briefTitle":74,"officialTitle":75,"acronym":34,"eligibilityCriteria":76,"healthyVolunteers":72,"sex":77,"minAge":78,"maxAge":34,"enrollmentInfo":79,"targetDuration":34,"studyType":82,"phases":83,"briefSummary":85,"conditions":86,"keywords":88,"overallStatus":93,"whyStopped":34,"lastUpdateSubmitDate":94,"lastUpdatePostDateStruct":95,"startDateStruct":98,"completionDateStruct":100,"leadSponsor":102,"locationsCount":103},{"fullName":5,"class":6},"Ospedali Riuniti Trieste","OTHER",[8,15],{"label":9,"type":10,"description":11,"interventionNames":12},"Treatment group","ACTIVE_COMPARATOR","co-ultramicronized Palmitoylethanolamide + Luteolin oral suspension (700 mg + 70 mg in 10 ml) in add-on to mechanical thrombectomy",[13,14],"Dietary Supplement: co-ultramicronized Palmitoylethanolamide + Luteolin (770 mg)","Procedure: Thrombectomy",{"label":16,"type":17,"description":18,"interventionNames":19},"Control group","PLACEBO_COMPARATOR","Placebo oral suspension in add-on to mechanical thrombectomy",[20,14],"Other: Placebo",[22,30,35],{"type":23,"name":24,"description":25,"armGroupLabels":26,"otherNames":27},"DIETARY_SUPPLEMENT","co-ultramicronized Palmitoylethanolamide + Luteolin (770 mg)","oral suspension, 10 ml twice a day (every 12 hours) for 7 days",[9],[28,29],"Glialia® oral suspension","PEALUT® oral suspension",{"type":6,"name":31,"description":32,"armGroupLabels":33,"otherNames":34},"Placebo","oral suspension,10 ml twice a day (every 12 hours) for 7 days",[16],null,{"type":36,"name":37,"description":38,"armGroupLabels":39,"otherNames":34},"PROCEDURE","Thrombectomy","Endovascular Thrombectomy in all eligible patients, according to national acute stroke treatment guidelines",[16,9],[41],{"name":42,"affiliation":43,"role":44},"Marcello Naccarato, MD, PhD","Azienda Sanitaria Universitaria Giuliano Isontina (ASU GI)","PRINCIPAL_INVESTIGATOR",[46,50],{"name":42,"role":47,"phone":48,"phoneExt":34,"email":49},"CONTACT","+39 0403994569","marcello.naccarato@asugi.sanita.fvg.it",{"name":51,"role":47,"phone":48,"phoneExt":34,"email":52},"Paola Caruso, MD","paola.caruso@asugi.sanita.fvg.it",[54],{"facility":55,"status":34,"city":56,"state":57,"zip":34,"country":57,"countryCode":58,"cosmosGeoPoint":59,"geoPoint":64,"contacts":65},"Azienda Sanitaria Universitaria Giuliano Isontina","Trieste","Italy","IT",{"type":60,"coordinates":61},"Point",[62,63],13.77678,45.64953,{"lat":63,"lon":62},[66],{"name":42,"role":47,"phone":48,"phoneExt":34,"email":49},{"type":44,"investigatorFullName":68,"investigatorTitle":69,"investigatorAffiliation":5,"oldNameTitle":34,"oldOrganization":34},"Marcello Naccarato","Principal Investigator","100575853","palmitoylethanolamide-and-luteolin-in-patients-with-acute-ischemic-stroke-100575853",false,"NCT06777680","Palmitoylethanolamide and Luteolin in Patients with Acute Ischemic Stroke","Efficacy of Palmitoylethanolamide and Luteolin on Early Functional Recovery in Acute Stroke Patients Treated with Thrombectomy: a Pilot Randomized Placebo-controlled Prospective Study","Inclusion Criteria:\n\n* age ≥ 60 years\n* both genders\n* first acute ischemic stroke in the middle cerebral artery area confirmed by angio-CT and CTP, eligible for mechanical thrombectomy according to national guidelines\n* NIHSS \\> 6\n* compliant patients\n* signed informed consent\n\nExclusion Criteria:\n\n* hemorrhagic stroke\n* previous stroke (TIA, ischemic or hemorrhagic stroke)\n* presence of clinically evident neurodegenerative diseases (Alzheimer's disease, Parkinson's disease)\n* presence of psychiatric comorbidity (schizophrenia, bipolar disorder, depressive syndrome)\n* presence of chronic inflammatory diseases (chronic inflammatory bowel disease, vasculitis etc.)\n* current or previous neoplasia\n* uncontrolled diabetes mellitus (glycemia on admission \\>400 mg\u002FdL or \\\u003C50 mg\u002FdL)\n* dysphagia, with inability to feed orally\n* inability to provide informed consent\n* pre-existing disability (pre-stroke mRS \\>2)\n* allergy or hypersensitivity to the study treatment","ALL","60 Years",{"count":80,"type":81},60,"ESTIMATED","INTERVENTIONAL",[84],"NA","Acute ischemic stroke is caused by reduced blood supply to the brain associated with neuroinflammation. This mechanism contributes to acute neuronal death and persists even after reopening of the closed vessel, with consequent limitation of clinical and functional improvement.\n\nExperimental and clinical evidence demonstrated the anti-inflammatory and neuroprotective effect of micronized and ultramicronized Palmitoylethanolamide (PEA).\n\nThe aim of this study is to evaluate the effect of co-ultramicronized PEA and luteolin (700 mg + 70 mg in 10 ml) on the clinical outcomes of patients with acute ischemic stroke undergoing mechanical thrombectomy.",[87],"Acute Ischemic Stroke AIS",[89,90,91,92],"Stroke","Neuroinflammation","Palmitoylethanolamide","Luteolin","NOT_YET_RECRUITING","2025-01-10",{"date":96,"type":97},"2025-01-16","ACTUAL",{"date":99,"type":81},"2025-01",{"date":101,"type":81},"2026-12",{"name":5,"class":6},1]