[{"data":1,"prerenderedAt":-1},["ShallowReactive",2],{"health-study-detail:100555660":3},{"organization":4,"outcomesModule":7,"designInfo":35,"detailedDescription":34,"studyPopulation":38,"armGroups":39,"interventions":48,"overallOfficials":34,"centralContacts":54,"locations":61,"responsibleParty":175,"collaborators":34,"id":177,"slug":34,"hasResults":178,"nctId":179,"briefTitle":180,"officialTitle":181,"acronym":34,"eligibilityCriteria":182,"healthyVolunteers":178,"sex":183,"minAge":184,"maxAge":34,"enrollmentInfo":185,"targetDuration":34,"studyType":188,"phases":34,"briefSummary":189,"conditions":190,"keywords":193,"overallStatus":64,"whyStopped":34,"lastUpdateSubmitDate":196,"lastUpdatePostDateStruct":197,"startDateStruct":200,"completionDateStruct":202,"leadSponsor":204,"locationsCount":205},{"fullName":5,"class":6},"POLYSAN Scientific & Technological Pharmaceutical Company","INDUSTRY",{"primaryOutcomes":8,"secondaryOutcomes":13,"otherOutcomes":34},[9],{"measure":10,"description":11,"timeFrame":12},"Percentage of patients with favorable functional outcome (score 0-2) according to Modified Rankin Scale (mRS) on Day of Discharge (assessment at Visit 4 or Visit 5, on Day of Discharge) and on Day 90;","Modified Rankin Scale (mRS)","Base, day 14, day 21, day 90",[14,17,21,24,27,31],{"measure":15,"description":11,"timeFrame":16},"Total score according to Modified Rankin Scale (mRS) on Day of Discharge and Day 90 in the test and control group;","Day 14, day 21, day 90",{"measure":18,"description":19,"timeFrame":20},"Total score according to Rivermead Scale on Day 7, Day 14, Day 21, and Day 90 in the test and control group","Rivermead Scale","Day 7, day 14, day 21, day 90",{"measure":22,"description":23,"timeFrame":20},"Change of the total score according to National Institute of Health Stroke Scale (NIHSS) on Day 3, Day 7, Day 14, and Day 21 as compared to the baseline level (Day 1);","National Institute of Health Stroke Scale (NIHSS)",{"measure":25,"description":26,"timeFrame":16},"Change of the total score according to Stroke-Specific Quality of Life Scale (SS-QOL) on Day 90 as compared to Day of Discharge;","Stroke-Specific Quality of Life Scale (SS-QOL)",{"measure":28,"description":29,"timeFrame":30},"Percentage of patients with repeated ACVA or TIA during the study;","Repeated ACVA or TIA","Day 90",{"measure":32,"description":33,"timeFrame":30},"Percentage of patients with lethal outcome in the period of hospitalization and follow-up","Lethal outcome",null,{"allocation":34,"interventionModel":34,"interventionModelDescription":34,"primaryPurpose":34,"observationalModel":36,"timePerspective":37,"maskingInfo":34},"CASE_CONTROL","PROSPECTIVE","Patients aged above 18 years with diagnosis of ACVA of ischemic type who did not receive and are not scheduled for reperfusion therapy (thrombolysis, thrombus extraction).",[40,45],{"label":41,"type":34,"description":42,"interventionNames":43},"The test group","Basic therapy + Cytoflavin",[44],"Drug: Cytoflavin",{"label":46,"type":34,"description":47,"interventionNames":34},"The control group","Basic therapy (with or without other neuroprotector)",[49],{"type":50,"name":51,"description":52,"armGroupLabels":53,"otherNames":34},"DRUG","Cytoflavin","Cytoflavin solution for infusions. 20-40 ml\u002Fday (10 ml with the interval of 8-12 hours for 10 days; the single dose is increased up to 20 ml in case of the severe form of the disease) by intravenous drop infusion in dilution per 100-200 ml of 0.9% sodium chloride solution for 10 days; rate of administration: 3-4 ml\u002Fmin",[41],[55],{"name":56,"role":57,"phone":58,"phoneExt":59,"email":60},"Alexey Kovalenko, Doc Biol Sci","CONTACT","+78127108225","212","science@polysan.ru",[62,74,82,87,95,100,105,113,121,126,131,136,141,146,151,159,167],{"facility":63,"status":64,"city":65,"state":34,"zip":34,"country":66,"countryCode":67,"cosmosGeoPoint":68,"geoPoint":73,"contacts":34},"\"Ivanovo Regional Clinical Hospital\"","RECRUITING","Ivanovo","Russia","RU",{"type":69,"coordinates":70},"Point",[71,72],40.97257,56.99988,{"lat":72,"lon":71},{"facility":75,"status":64,"city":76,"state":34,"zip":34,"country":66,"countryCode":67,"cosmosGeoPoint":77,"geoPoint":81,"contacts":34},"Kazan State Medical University","Kazan'",{"type":69,"coordinates":78},[79,80],49.12214,55.78874,{"lat":80,"lon":79},{"facility":83,"status":64,"city":76,"state":34,"zip":34,"country":66,"countryCode":67,"cosmosGeoPoint":84,"geoPoint":86,"contacts":34},"State Autonomous Institution of Health Interregional clinical diagnostic center",{"type":69,"coordinates":85},[79,80],{"lat":80,"lon":79},{"facility":88,"status":64,"city":89,"state":34,"zip":34,"country":66,"countryCode":67,"cosmosGeoPoint":90,"geoPoint":94,"contacts":34},"Moscow City Clinical Hospital No.64 (CCH named after V.V. Vinogradov)","Moscow",{"type":69,"coordinates":91},[92,93],37.61781,55.75204,{"lat":93,"lon":92},{"facility":96,"status":64,"city":89,"state":34,"zip":34,"country":66,"countryCode":67,"cosmosGeoPoint":97,"geoPoint":99,"contacts":34},"N.I. Pirogov City Clinical Hospital No. 1",{"type":69,"coordinates":98},[92,93],{"lat":93,"lon":92},{"facility":101,"status":64,"city":89,"state":34,"zip":34,"country":66,"countryCode":67,"cosmosGeoPoint":102,"geoPoint":104,"contacts":34},"Vorohobov's City Clinical Hospital №67",{"type":69,"coordinates":103},[92,93],{"lat":93,"lon":92},{"facility":106,"status":64,"city":107,"state":34,"zip":34,"country":66,"countryCode":67,"cosmosGeoPoint":108,"geoPoint":112,"contacts":34},"City Clinical Hospital No. 1 Novosibirsk","Novosibirsk",{"type":69,"coordinates":109},[110,111],82.93175,55.02259,{"lat":111,"lon":110},{"facility":114,"status":64,"city":115,"state":34,"zip":34,"country":66,"countryCode":67,"cosmosGeoPoint":116,"geoPoint":120,"contacts":34},"Alexandrovskaya hospital","Saint Petersburg",{"type":69,"coordinates":117},[118,119],30.31413,59.93863,{"lat":119,"lon":118},{"facility":122,"status":64,"city":115,"state":34,"zip":34,"country":66,"countryCode":67,"cosmosGeoPoint":123,"geoPoint":125,"contacts":34},"Almazov National Medical Research Centr",{"type":69,"coordinates":124},[118,119],{"lat":119,"lon":118},{"facility":127,"status":64,"city":115,"state":34,"zip":34,"country":66,"countryCode":67,"cosmosGeoPoint":128,"geoPoint":130,"contacts":34},"City Mariinsky Hospital",{"type":69,"coordinates":129},[118,119],{"lat":119,"lon":118},{"facility":132,"status":64,"city":115,"state":34,"zip":34,"country":66,"countryCode":67,"cosmosGeoPoint":133,"geoPoint":135,"contacts":34},"Nikolaevskaya Hospital",{"type":69,"coordinates":134},[118,119],{"lat":119,"lon":118},{"facility":137,"status":64,"city":115,"state":34,"zip":34,"country":66,"countryCode":67,"cosmosGeoPoint":138,"geoPoint":140,"contacts":34},"Saint-Petersburg I. I. Dzhanelidze research institute of emergency medicine",{"type":69,"coordinates":139},[118,119],{"lat":119,"lon":118},{"facility":142,"status":64,"city":115,"state":34,"zip":34,"country":66,"countryCode":67,"cosmosGeoPoint":143,"geoPoint":145,"contacts":34},"St. Petersburg State Budgetary Institution of Public Health \"City Hospital No. 40 of Kurortny District\"",{"type":69,"coordinates":144},[118,119],{"lat":119,"lon":118},{"facility":147,"status":64,"city":115,"state":34,"zip":34,"country":66,"countryCode":67,"cosmosGeoPoint":148,"geoPoint":150,"contacts":34},"The City Hospital of the Holy Martyr Elizabeth",{"type":69,"coordinates":149},[118,119],{"lat":119,"lon":118},{"facility":152,"status":64,"city":153,"state":34,"zip":34,"country":66,"countryCode":67,"cosmosGeoPoint":154,"geoPoint":158,"contacts":34},"Smolensk Regional Clinical Hospital","Smolensk",{"type":69,"coordinates":155},[156,157],32.05088,54.77826,{"lat":157,"lon":156},{"facility":160,"status":64,"city":161,"state":34,"zip":34,"country":66,"countryCode":67,"cosmosGeoPoint":162,"geoPoint":166,"contacts":34},"Municipal Clinical Hospital #13, the City of Ufa, State Budgetary Healthcare Institution of the Republic of Bashkortostan","Ufa",{"type":69,"coordinates":163},[164,165],55.96779,54.74306,{"lat":165,"lon":164},{"facility":168,"status":64,"city":169,"state":34,"zip":34,"country":66,"countryCode":67,"cosmosGeoPoint":170,"geoPoint":174,"contacts":34},"Budgetary healthcare institution of the Voronezh region \"Voronezh Regional Clinical Hospital No. 1\"","Voronezh",{"type":69,"coordinates":171},[172,173],39.19204,51.66833,{"lat":173,"lon":172},{"type":176,"investigatorFullName":34,"investigatorTitle":34,"investigatorAffiliation":34,"oldNameTitle":34,"oldOrganization":34},"SPONSOR","100555660",false,"NCT06514976","Observational Study of Efficiency of Cytoflavin, in Patients With Ischemic Stroke Not Receiving Reperfusion Therapy","Multi-center International Observational Study of Efficiency of the Drug Cytoflavin®, Solution for Infusions in Patients With Ischemic Stroke Not Receiving Reperfusion Therapy.","Inclusion Criteria:\n\n1. Signed informed consent form\n2. Age from 18 years and older\n3. Diagnosis: Acute cerebrovascular accident of ischemic type (ischemic stroke) developed within 36 hours before enrollment in the study\n4. Motor neurologic deficit measurable using the NIHSS Scale (score for item 5 and\u002For 6 at the time of starting the therapy ≥ 1))\n5. Conservative stroke treatment tactics (without reperfusion therapy thrombolysis\u002Fthrombus extraction)\n6. According to the routine clinical practice, the patient is scheduled to receive the treatment as per one of the following regimens:\n\n   * Cytoflavin® 20-40 ml\u002Fday as a course of not less than 10 days or\n   * another neuroprotector - course of not less than 10 days (or without neuroprotector)\n\nExclusion Criteria:\n\n1. NIHSS 1a (coma) score 3 at the time of enrollment\n2. Initial severe disablement (corresponding to mRS \\> 2) requiring external assistance in everyday life before development of stroke\n3. History of Parkinson's disease, dementia, multiple sclerosis, and other significant diseases accompanied by neurologic deficit\n4. Severe comorbidity with expected lifespan of not more than 6 months\n5. Pregnancy and breastfeeding\n6. Any other concomitant medical or serious psychic conditions, which make the patient ineligible for participation in the study, restrict lawfulness of obtaining the informed consent, or can influence the patient's ability to participate in the study","ALL","18 Years",{"count":186,"type":187},562,"ESTIMATED","OBSERVATIONAL","Stroke remains one of the main socially significant problems in the healthcare in the third millennium. The lethality in persons with history of stroke by the end of the 1st year of disease is high. A trend to increased frequency of stroke in the young age is observed during the last decade; third of patients is working-age individuals, out of whom only 15-20% returns to labor, and others remain disabled persons requiring constant medical and social support",[191,192],"Stroke, Acute","Stroke, Ischemic",[194,195],"stroke","сytoflavin","2025-04-15",{"date":198,"type":199},"2025-04-18","ACTUAL",{"date":201,"type":199},"2024-03-01",{"date":203,"type":187},"2025-11-01",{"name":5,"class":6},17]