Ignite Creation Date:
2025-12-24 @ 11:48 PM
Ignite Modification Date:
2025-12-25 @ 9:42 PM
Study NCT ID:
NCT05297851
Status:
COMPLETED
Last Update Posted:
2023-03-20
First Post:
2022-03-17
Is NOT Gene Therapy:
False
Has Adverse Events:
False
Brief Title:
Cytoflavin in Combination With Reperfusion in Stroke Patients
Sponsor:
Organization:
Raw JSON
{'hasResults': False, 'derivedSection': {'miscInfoModule': {'versionHolder': '2025-12-24'}, 'conditionBrowseModule': {'meshes': [{'id': 'D020521', 'term': 'Stroke'}, {'id': 'D002544', 'term': 'Cerebral Infarction'}], 'ancestors': [{'id': 'D002561', 'term': 'Cerebrovascular Disorders'}, {'id': 'D001927', 'term': 'Brain Diseases'}, {'id': 'D002493', 'term': 'Central Nervous System Diseases'}, {'id': 'D009422', 'term': 'Nervous System Diseases'}, {'id': 'D014652', 'term': 'Vascular Diseases'}, {'id': 'D002318', 'term': 'Cardiovascular Diseases'}, {'id': 'D020520', 'term': 'Brain Infarction'}, {'id': 'D002545', 'term': 'Brain Ischemia'}, {'id': 'D007238', 'term': 'Infarction'}, {'id': 'D007511', 'term': 'Ischemia'}, {'id': 'D010335', 'term': 'Pathologic Processes'}, {'id': 'D013568', 'term': 'Pathological Conditions, Signs and Symptoms'}, {'id': 'D009336', 'term': 'Necrosis'}]}, 'interventionBrowseModule': {'meshes': [{'id': 'C507879', 'term': 'cytoflavin'}, {'id': 'D019802', 'term': 'Succinic Acid'}, {'id': 'D007288', 'term': 'Inosine'}, {'id': 'D009536', 'term': 'Niacinamide'}, {'id': 'D012256', 'term': 'Riboflavin'}], 'ancestors': [{'id': 'D013386', 'term': 'Succinates'}, {'id': 'D003998', 'term': 'Dicarboxylic Acids'}, {'id': 'D000144', 'term': 'Acids, Acyclic'}, {'id': 'D002264', 'term': 'Carboxylic Acids'}, {'id': 'D009930', 'term': 'Organic Chemicals'}, {'id': 'D011684', 'term': 'Purine Nucleosides'}, {'id': 'D011687', 'term': 'Purines'}, {'id': 'D006574', 'term': 'Heterocyclic Compounds, 2-Ring'}, {'id': 'D000072471', 'term': 'Heterocyclic Compounds, Fused-Ring'}, {'id': 'D006571', 'term': 'Heterocyclic Compounds'}, {'id': 'D009705', 'term': 'Nucleosides'}, {'id': 'D009706', 'term': 'Nucleic Acids, Nucleotides, and Nucleosides'}, {'id': 'D012263', 'term': 'Ribonucleosides'}, {'id': 'D009539', 'term': 'Nicotinic Acids'}, {'id': 'D000147', 'term': 'Acids, Heterocyclic'}, {'id': 'D011725', 'term': 'Pyridines'}, {'id': 'D006573', 'term': 'Heterocyclic Compounds, 1-Ring'}, {'id': 'D005415', 'term': 'Flavins'}, {'id': 'D011621', 'term': 'Pteridines'}, {'id': 'D006575', 'term': 'Heterocyclic Compounds, 3-Ring'}, {'id': 'D003067', 'term': 'Coenzymes'}, {'id': 'D045762', 'term': 'Enzymes and Coenzymes'}, {'id': 'D010860', 'term': 'Pigments, Biological'}, {'id': 'D001685', 'term': 'Biological Factors'}]}}, 'protocolSection': {'designModule': {'studyType': 'OBSERVATIONAL', 'designInfo': {'timePerspective': 'PROSPECTIVE', 'observationalModel': 'CASE_CONTROL'}, 'enrollmentInfo': {'type': 'ACTUAL', 'count': 200}, 'patientRegistry': False}, 'statusModule': {'overallStatus': 'COMPLETED', 'startDateStruct': {'date': '2022-04-10', 'type': 'ACTUAL'}, 'expandedAccessInfo': {'hasExpandedAccess': False}, 'statusVerifiedDate': '2023-03', 'completionDateStruct': {'date': '2023-03-01', 'type': 'ACTUAL'}, 'lastUpdateSubmitDate': '2023-03-16', 'studyFirstSubmitDate': '2022-03-17', 'studyFirstSubmitQcDate': '2022-03-17', 'lastUpdatePostDateStruct': {'date': '2023-03-20', 'type': 'ACTUAL'}, 'studyFirstPostDateStruct': {'date': '2022-03-28', 'type': 'ACTUAL'}, 'primaryCompletionDateStruct': {'date': '2023-02-28', 'type': 'ACTUAL'}}, 'outcomesModule': {'primaryOutcomes': [{'measure': 'Proportion of patients with good functional outcome', 'timeFrame': '90 days', 'description': 'Proportion of patients who achieve score 0-2 by modified Rankin scale'}]}, 'oversightModule': {'oversightHasDmc': False, 'isFdaRegulatedDrug': False, 'isFdaRegulatedDevice': False}, 'conditionsModule': {'keywords': ['acute stroke', 'cerebral infarction', 'neuroprotection'], 'conditions': ['Acute Stroke']}, 'descriptionModule': {'briefSummary': 'Evaluation of the efficacy and safety of Cytoflavin®, solution for intravenous administration, (OOO NTFF POLYSAN, Russia) for 10 days, patients with cerebral infarction who receive reperfusion therapy, with the start of treatment within the first 24 hours from the stroke onset, compared to treament with any other neuroprotective drug which may be used in routine clinical practice.'}, 'eligibilityModule': {'sex': 'ALL', 'stdAges': ['ADULT', 'OLDER_ADULT'], 'maximumAge': '85 Years', 'minimumAge': '18 Years', 'samplingMethod': 'NON_PROBABILITY_SAMPLE', 'studyPopulation': 'Men and women 18-85 y.o. with acute stroke who receive reperfusion (intravenous thrombolysis and/or mechanical thrombectomy) and continue treatment in the acute stroke unit', 'eligibilityCriteria': 'Inclusion Criteria:\n\n1. Signed Informed Consent;\n2. Men and women 18-85 y.o.;\n3. A diagnosis of "cerebral infarction" has been established and treatment with Cytoflavin® has already been prescribed, or other therapy has been prescribed that does not include Cytoflavin®;\n4. NIHSS score of at least 5 and less than 24;\n5. reperfusion therapy performed on admission;\n6. The size of the ischemic focus according to ASPECTS score \\>=6;\n7. Time from stroke onset to admission not exceeeding 6 hours;\n8. Start of therapy with Cytoflavin® within 24 hours from the onset of stroke (main group);\n9. Patients who are able to follow the procedures of the Observational Study Program and strictly follow the doctor\'s instructions regarding drug therapy.\n\nExclusion Criteria:\n\n1. Individual intolerance or known hypersensitivity to succinic acid, inosine, nicotinamide, riboflavin, or auxiliary components of the drug Cytoflavin®;\n2. Hemorrhagic stroke;\n3. Contraindications for CT scanning;\n4. Initial severe disability requiring assistance in everyday life before stroke;\n5. previous stroke with a residual neurological deficit;\n6. Severe comorbidity with a life expectancy of less than 6 months;\n7. Clinical or laboratory signs of an infectious disease on admission (with the exception of strokes that occurred in COVID-19 convalescents after the first 10 days of illness, and patients with asymptomatic SARS-CoV-2 infection detected during routine examination);\n8. Pregnancy or lactation'}, 'identificationModule': {'nctId': 'NCT05297851', 'briefTitle': 'Cytoflavin in Combination With Reperfusion in Stroke Patients', 'organization': {'class': 'INDUSTRY', 'fullName': 'POLYSAN Scientific & Technological Pharmaceutical Company'}, 'officialTitle': 'Non-interventional Prospective Observational Study of Efficacy and Safety of Cytoflavin in Combination With Reperfusion Compared to Treatment With Other Neuroprotective Drugs Used in Routine Clinical Practice in Patients With Cerebral Infarction', 'orgStudyIdInfo': {'id': 'CTF-STRobs-22'}}, 'armsInterventionsModule': {'armGroups': [{'label': 'Cytoflavin', 'description': 'Patients who underwent reperfusion for acute stroke (intravenous thrombolysis and/or mechanical thrombectomy) and receive intravenous Cytoflavin® at a discretion of the physician, starting this treatment within the first 24 hours from the onset of stroke', 'interventionNames': ['Drug: Cytoflavin (succinic acid + inosine + nicotinamide + riboflavin)']}, {'label': 'Control', 'description': 'Patients who underwent reperfusion for acute stroke (intravenous thrombolysis and/or mechanical thrombectomy) and do not receive Cytoflavin as part of their routine clinical practice, but may receive any other neuroprotective medications.', 'interventionNames': ['Drug: Control']}], 'interventions': [{'name': 'Cytoflavin (succinic acid + inosine + nicotinamide + riboflavin)', 'type': 'DRUG', 'description': '10 ml diluted to 100-200 ml of 5-10% dextroseor 0.9% sodium chloride solution. The rate of administration is 3-4 ml / min. The drug is administered in a volume of 10 ml per injection with an interval of 8-12 hours for 10 days. In severe cases of the disease, a single dose is increased to 20 ml.', 'armGroupLabels': ['Cytoflavin']}, {'name': 'Control', 'type': 'DRUG', 'description': 'Standard treatment accordind to the routine clinical practice', 'armGroupLabels': ['Control']}]}, 'contactsLocationsModule': {'locations': [{'city': 'Arkhangelsk', 'country': 'Russia', 'facility': 'Northern State Medical University of the Ministry of Health of the Russian Federation', 'geoPoint': {'lat': 64.5461, 'lon': 40.55183}}, {'city': 'Belgorod', 'country': 'Russia', 'facility': 'Belgorod Regional Clinical Hospital of St. Joasaph', 'geoPoint': {'lat': 50.60343, 'lon': 36.58091}}, {'city': "Kazan'", 'country': 'Russia', 'facility': 'Interregional Clinical and Diagnostic Center', 'geoPoint': {'lat': 55.78874, 'lon': 49.12214}}, {'zip': '197706', 'city': 'Saint Petersburg', 'country': 'Russia', 'facility': 'City Hospital of the Holy Martyr Elizabeth', 'geoPoint': {'lat': 59.93863, 'lon': 30.31413}}, {'city': 'Saint Petersburg', 'country': 'Russia', 'facility': 'City General Hospital №2', 'geoPoint': {'lat': 59.93863, 'lon': 30.31413}}, {'city': 'Saint Petersburg', 'country': 'Russia', 'facility': 'City Mariinsky Hospital', 'geoPoint': {'lat': 59.93863, 'lon': 30.31413}}, {'city': 'Saint Petersburg', 'country': 'Russia', 'facility': 'SPb GBUZ "City Hospital №26"', 'geoPoint': {'lat': 59.93863, 'lon': 30.31413}}], 'overallOfficials': [{'name': 'Dina R Khasanova, prof.', 'role': 'PRINCIPAL_INVESTIGATOR', 'affiliation': 'Interregional Clinical and Diagnostic Center, Kazan, Russia'}]}, 'ipdSharingStatementModule': {'ipdSharing': 'UNDECIDED'}, 'sponsorCollaboratorsModule': {'leadSponsor': {'name': 'POLYSAN Scientific & Technological Pharmaceutical Company', 'class': 'INDUSTRY'}, 'responsibleParty': {'type': 'SPONSOR'}}}}