Ignite Creation Date:
2025-12-25 @ 1:25 AM
Ignite Modification Date:
2026-02-12 @ 5:45 AM
Study NCT ID:
NCT03151993
Status:
COMPLETED
Last Update Posted:
2025-04-02
First Post:
2017-05-10
Is Gene Therapy:
True
Has Adverse Events:
True
Brief Title:
Single Bolus Recombinant Nonimmunogenic Staphylokinase (Fortelyzin) and Bolus Infusion Alteplase in Patients With AIS
Sponsor:
Organization:
Raw JSON
{'hasResults': True, 'derivedSection': {'miscInfoModule': {'versionHolder': '2025-12-24'}, 'conditionBrowseModule': {'meshes': [{'id': 'D000083242', 'term': 'Ischemic Stroke'}], 'ancestors': [{'id': 'D020521', 'term': 'Stroke'}, {'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'}]}, 'interventionBrowseModule': {'meshes': [{'id': 'D010959', 'term': 'Tissue Plasminogen Activator'}], 'ancestors': [{'id': 'D012697', 'term': 'Serine Endopeptidases'}, {'id': 'D010450', 'term': 'Endopeptidases'}, {'id': 'D010447', 'term': 'Peptide Hydrolases'}, {'id': 'D006867', 'term': 'Hydrolases'}, {'id': 'D004798', 'term': 'Enzymes'}, {'id': 'D045762', 'term': 'Enzymes and Coenzymes'}, {'id': 'D057057', 'term': 'Serine Proteases'}, {'id': 'D010960', 'term': 'Plasminogen Activators'}, {'id': 'D001779', 'term': 'Blood Coagulation Factors'}, {'id': 'D001798', 'term': 'Blood Proteins'}, {'id': 'D011506', 'term': 'Proteins'}, {'id': 'D000602', 'term': 'Amino Acids, Peptides, and Proteins'}, {'id': 'D001685', 'term': 'Biological Factors'}]}}, 'resultsSection': {'moreInfoModule': {'pointOfContact': {'email': 'egusev2339@gmail.com', 'phone': '495-280-01-74', 'title': 'Dr. Eugene I. Gusev, President of the Federal Center for Brain and Neurotechnology', 'phoneExt': '+7', 'organization': 'Federal Center for Brain and Neurotechnology'}, 'certainAgreement': {'piSponsorEmployee': False, 'restrictiveAgreement': False}}, 'adverseEventsModule': {'timeFrame': '90 days after fibronolysis', 'description': 'Cerebral oedema, Symptomatic intracranial haemorrhage, Surgery, Neurosurgery, Acute myocardial infarction, Pulmonary thromboembolism, New acute ischaemic stroke, Gastric ulcer, Takotsubo cardiomyopathy.', 'eventGroups': [{'id': 'EG000', 'title': 'Recombinant Staphylokinase', 'description': 'Lyophilizate for solution making for intravenous injection, 5 mg (745000 ME). 10 mg of drug reconstituted in 10 ml of 0.9% solution of NaCl given as single i.v. bolus over 5 - 10 seconds\n\nRecombinant staphylokinase: 10 mg of drug reconstituted in 10 ml of 0.9% solution of NaCl given as single i.v. bolus over 5 - 10 seconds', 'otherNumAtRisk': 168, 'deathsNumAtRisk': 168, 'otherNumAffected': 7, 'seriousNumAtRisk': 168, 'deathsNumAffected': 17, 'seriousNumAffected': 22}, {'id': 'EG001', 'title': 'Actilyse', 'description': 'Intravenous alteplase 0.9 mg/kg (10% bolus and 90% as IV infusion over 1 hour, maximum 90 mg)\n\nAlteplase: Intravenous alteplase 0.9 mg/kg (10% bolus and 90% as IV infusion over 1 hour, maximum 90 mg)', 'otherNumAtRisk': 168, 'deathsNumAtRisk': 168, 'otherNumAffected': 8, 'seriousNumAtRisk': 168, 'deathsNumAffected': 24, 'seriousNumAffected': 38}], 'otherEvents': [{'term': 'Haematuria', 'stats': [{'groupId': 'EG000', 'numAtRisk': 168, 'numEvents': 7, 'numAffected': 7}, {'groupId': 'EG001', 'numAtRisk': 168, 'numEvents': 8, 'numAffected': 8}], 'organSystem': 'Renal and urinary disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT'}], 'seriousEvents': [{'term': 'Cerebral oedema', 'stats': [{'groupId': 'EG000', 'numAtRisk': 168, 'numEvents': 7, 'numAffected': 7}, {'groupId': 'EG001', 'numAtRisk': 168, 'numEvents': 14, 'numAffected': 14}], 'organSystem': 'Nervous system disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT'}, {'term': 'Symptomatic intracranial haemorrhage', 'stats': [{'groupId': 'EG000', 'numAtRisk': 168, 'numEvents': 5, 'numAffected': 5}, {'groupId': 'EG001', 'numAtRisk': 168, 'numEvents': 13, 'numAffected': 13}], 'organSystem': 'Nervous system disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT'}, {'term': 'Surgery', 'stats': [{'groupId': 'EG000', 'numAtRisk': 168, 'numEvents': 5, 'numAffected': 5}, {'groupId': 'EG001', 'numAtRisk': 168, 'numEvents': 3, 'numAffected': 3}], 'organSystem': 'Nervous system disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT'}, {'term': 'Neurosurgery', 'stats': [{'groupId': 'EG000', 'numAtRisk': 168, 'numEvents': 2, 'numAffected': 2}, {'groupId': 'EG001', 'numAtRisk': 168, 'numEvents': 1, 'numAffected': 1}], 'organSystem': 'Nervous system disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT'}, {'term': 'Acute myocardial infarction', 'stats': [{'groupId': 'EG000', 'numAtRisk': 168, 'numEvents': 1, 'numAffected': 1}, {'groupId': 'EG001', 'numAtRisk': 168, 'numEvents': 1, 'numAffected': 1}], 'organSystem': 'Cardiac disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT'}, {'term': 'Pulmonary thromboembolism', 'stats': [{'groupId': 'EG000', 'numAtRisk': 168, 'numEvents': 1, 'numAffected': 1}, {'groupId': 'EG001', 'numAtRisk': 168, 'numEvents': 3, 'numAffected': 3}], 'organSystem': 'Blood and lymphatic system disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT'}, {'term': 'New acute ischaemic stroke', 'stats': [{'groupId': 'EG000', 'numAtRisk': 168, 'numEvents': 1, 'numAffected': 1}, {'groupId': 'EG001', 'numAtRisk': 168, 'numEvents': 0, 'numAffected': 0}], 'organSystem': 'Nervous system disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT'}, {'term': 'Gastric ulcer', 'stats': [{'groupId': 'EG000', 'numAtRisk': 168, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG001', 'numAtRisk': 168, 'numEvents': 2, 'numAffected': 2}], 'organSystem': 'Gastrointestinal disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT'}, {'term': 'Takotsubo cardiomyopathy', 'stats': [{'groupId': 'EG000', 'numAtRisk': 168, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG001', 'numAtRisk': 168, 'numEvents': 1, 'numAffected': 1}], 'organSystem': 'Cardiac disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT'}], 'frequencyThreshold': '5'}, 'outcomeMeasuresModule': {'outcomeMeasures': [{'type': 'PRIMARY', 'title': 'Good Functional Recovery', 'denoms': [{'units': 'Participants', 'counts': [{'value': '168', 'groupId': 'OG000'}, {'value': '168', 'groupId': 'OG001'}]}], 'groups': [{'id': 'OG000', 'title': 'Recombinant Staphylokinase', 'description': 'Lyophilizate for solution making for intravenous injection, 5 mg (745000 ME). 10 mg of drug reconstituted in 10 ml of 0.9% solution of NaCl given as single i.v. bolus over 5 - 10 seconds\n\nRecombinant staphylokinase: 10 mg of drug reconstituted in 10 ml of 0.9% solution of NaCl given as single i.v. bolus over 5 - 10 seconds'}, {'id': 'OG001', 'title': 'Actilyse', 'description': 'Intravenous alteplase 0.9 mg/kg (10% bolus and 90% as IV infusion over 1 hour, maximum 90 mg)\n\nAlteplase: Intravenous alteplase 0.9 mg/kg (10% bolus and 90% as IV infusion over 1 hour, maximum 90 mg)'}], 'classes': [{'categories': [{'measurements': [{'value': '84', 'groupId': 'OG000'}, {'value': '68', 'groupId': 'OG001'}]}]}], 'analyses': [{'pValue': '<0.01', 'groupIds': ['OG000', 'OG001'], 'paramType': 'Odds Ratio (OR)', 'ciNumSides': 'TWO_SIDED', 'ciPctValue': '95', 'paramValue': '9.5', 'ciLowerLimit': '-1.7', 'ciUpperLimit': '20.7', 'statisticalMethod': "Welch's t-test", 'nonInferiorityType': 'NON_INFERIORITY', 'nonInferiorityComment': "The non-inferiority hypothesis would be declared if the lower limit of the 95% CI for an mRS score of 0-1 on day 90 did not cross the margin of noninferiority of 16%. The non-inferiority hypothesis was tested using Welch's t-test for the primary outcome only."}], 'paramType': 'NUMBER', 'timeFrame': 'within 90 days after fibrinolysis', 'description': 'The number of patients with Modified Rankin Scale (mRS) scores 0-1 on day 90 after drug administration, where 0 - No symptoms, 1 - No significant disability. All scale is 0 - No symptoms, 1 - No significant disability, 2 - Slight disability, 3 - Moderate disability, 4 - Moderately severe disability, 5 - Severe disability, 6 - Dead.', 'unitOfMeasure': 'patients', 'reportingStatus': 'POSTED'}, {'type': 'SECONDARY', 'title': 'The Number of Patients With Modified Rankin Scale (0-1) + NIHSS (0-1) + Barthel (95-100)', 'denoms': [{'units': 'Participants', 'counts': [{'value': '168', 'groupId': 'OG000'}, {'value': '168', 'groupId': 'OG001'}]}], 'groups': [{'id': 'OG000', 'title': 'Recombinant Staphylokinase', 'description': 'Lyophilizate for solution making for intravenous injection, 5 mg (745000 ME). 10 mg of drug reconstituted in 10 ml of 0.9% solution of NaCl given as single i.v. bolus over 5 - 10 seconds\n\nRecombinant staphylokinase: 10 mg of drug reconstituted in 10 ml of 0.9% solution of NaCl given as single i.v. bolus over 5 - 10 seconds'}, {'id': 'OG001', 'title': 'Actilyse', 'description': 'Intravenous alteplase 0.9 mg/kg (10% bolus and 90% as IV infusion over 1 hour, maximum 90 mg)\n\nAlteplase: Intravenous alteplase 0.9 mg/kg (10% bolus and 90% as IV infusion over 1 hour, maximum 90 mg)'}], 'classes': [{'categories': [{'measurements': [{'value': '59', 'groupId': 'OG000'}, {'value': '52', 'groupId': 'OG001'}]}]}], 'paramType': 'NUMBER', 'timeFrame': 'within 90 days after fibrinolysis', 'description': 'Composite endpoint, included the number of patients reached Modified Rankin scale 0-1 score, NIHSS 0-1 score and Barthel index 95-100.\n\nModified Rankin scale: 0 - No symptoms, 1 - No significant disability, 2 - Slight disability, 3 - Moderate disability, 4 - Moderately severe disability, 5 - Severe disability, 6 - Dead.\n\nThe National Institutes of Health Stroke Scale (NIHSS): 0 - No stroke symptoms, 1-4 - Minor stroke, 5-15 - Moderate stroke, 16-20 - Moderate to severe stroke, 21-42 - Severe stroke.\n\nBarthel index: 80-100 - Independent, 60-79 - Minimally dependent, 40-59 - Partially dependent, 20-39 - Very dependent, \\<20 - Totally dependent.', 'unitOfMeasure': 'patients', 'reportingStatus': 'POSTED'}, {'type': 'SECONDARY', 'title': 'The Median of NIHSS After 24 Hours', 'denoms': [{'units': 'Participants', 'counts': [{'value': '168', 'groupId': 'OG000'}, {'value': '168', 'groupId': 'OG001'}]}], 'groups': [{'id': 'OG000', 'title': 'Recombinant Staphylokinase', 'description': 'Lyophilizate for solution making for intravenous injection, 5 mg (745000 ME). 10 mg of drug reconstituted in 10 ml of 0.9% solution of NaCl given as single i.v. bolus over 5 - 10 seconds\n\nRecombinant staphylokinase: 10 mg of drug reconstituted in 10 ml of 0.9% solution of NaCl given as single i.v. bolus over 5 - 10 seconds'}, {'id': 'OG001', 'title': 'Actilyse', 'description': 'Intravenous alteplase 0.9 mg/kg (10% bolus and 90% as IV infusion over 1 hour, maximum 90 mg)\n\nAlteplase: Intravenous alteplase 0.9 mg/kg (10% bolus and 90% as IV infusion over 1 hour, maximum 90 mg)'}], 'classes': [{'categories': [{'measurements': [{'value': '6', 'groupId': 'OG000', 'lowerLimit': '3', 'upperLimit': '11'}, {'value': '6', 'groupId': 'OG001', 'lowerLimit': '3', 'upperLimit': '12'}]}]}], 'paramType': 'MEDIAN', 'timeFrame': 'after 24 hours', 'description': 'The median of The National Institutes of Health Stroke Scale (NIHSS) at 24 h after drug administration, where: 0 - No stroke symptoms, 1-4 - Minor stroke, 5-15 - Moderate stroke, 16-20 - Moderate to severe stroke, 21-42 - Severe stroke.', 'unitOfMeasure': 'score', 'dispersionType': 'Inter-Quartile Range', 'reportingStatus': 'POSTED'}, {'type': 'SECONDARY', 'title': 'The Median of NIHSS After 90 Days', 'denoms': [{'units': 'Participants', 'counts': [{'value': '168', 'groupId': 'OG000'}, {'value': '168', 'groupId': 'OG001'}]}], 'groups': [{'id': 'OG000', 'title': 'Recombinant Staphylokinase', 'description': 'Lyophilizate for solution making for intravenous injection, 5 mg (745000 ME). 10 mg of drug reconstituted in 10 ml of 0.9% solution of NaCl given as single i.v. bolus over 5 - 10 seconds\n\nRecombinant staphylokinase: 10 mg of drug reconstituted in 10 ml of 0.9% solution of NaCl given as single i.v. bolus over 5 - 10 seconds'}, {'id': 'OG001', 'title': 'Actilyse', 'description': 'Intravenous alteplase 0.9 mg/kg (10% bolus and 90% as IV infusion over 1 hour, maximum 90 mg)\n\nAlteplase: Intravenous alteplase 0.9 mg/kg (10% bolus and 90% as IV infusion over 1 hour, maximum 90 mg)'}], 'classes': [{'categories': [{'measurements': [{'value': '2', 'groupId': 'OG000', 'lowerLimit': '1', 'upperLimit': '5'}, {'value': '2', 'groupId': 'OG001', 'lowerLimit': '1', 'upperLimit': '5'}]}]}], 'paramType': 'MEDIAN', 'timeFrame': 'within 90 days after fibrinolysis', 'description': 'The median of The National Institutes of Health Stroke Scale (NIHSS) after 90 days of drug administration, where: 0 - No stroke symptoms, 1-4 - Minor stroke, 5-15 - Moderate stroke, 16-20 - Moderate to severe stroke, 21-42 - Severe stroke.', 'unitOfMeasure': 'score', 'dispersionType': 'Inter-Quartile Range', 'reportingStatus': 'POSTED'}, {'type': 'SECONDARY', 'title': 'All Cause Death', 'denoms': [{'units': 'Participants', 'counts': [{'value': '168', 'groupId': 'OG000'}, {'value': '168', 'groupId': 'OG001'}]}], 'groups': [{'id': 'OG000', 'title': 'Recombinant Staphylokinase', 'description': 'Lyophilizate for solution making for intravenous injection, 5 mg (745000 ME). 10 mg of drug reconstituted in 10 ml of 0.9% solution of NaCl given as single i.v. bolus over 5 - 10 seconds\n\nRecombinant staphylokinase: 10 mg of drug reconstituted in 10 ml of 0.9% solution of NaCl given as single i.v. bolus over 5 - 10 seconds'}, {'id': 'OG001', 'title': 'Actilyse', 'description': 'Intravenous alteplase 0.9 mg/kg (10% bolus and 90% as IV infusion over 1 hour, maximum 90 mg)\n\nAlteplase: Intravenous alteplase 0.9 mg/kg (10% bolus and 90% as IV infusion over 1 hour, maximum 90 mg)'}], 'classes': [{'categories': [{'measurements': [{'value': '17', 'groupId': 'OG000'}, {'value': '24', 'groupId': 'OG001'}]}]}], 'paramType': 'NUMBER', 'timeFrame': 'within 90 days after fibrinolysis', 'description': 'Death caused by any event', 'unitOfMeasure': 'patients', 'reportingStatus': 'POSTED'}, {'type': 'SECONDARY', 'title': 'Intracranial Haemorrhage', 'denoms': [{'units': 'Participants', 'counts': [{'value': '168', 'groupId': 'OG000'}, {'value': '168', 'groupId': 'OG001'}]}], 'groups': [{'id': 'OG000', 'title': 'Recombinant Staphylokinase', 'description': 'Lyophilizate for solution making for intravenous injection, 5 mg (745000 ME). 10 mg of drug reconstituted in 10 ml of 0.9% solution of NaCl given as single i.v. bolus over 5 - 10 seconds\n\nRecombinant staphylokinase: 10 mg of drug reconstituted in 10 ml of 0.9% solution of NaCl given as single i.v. bolus over 5 - 10 seconds'}, {'id': 'OG001', 'title': 'Actilyse', 'description': 'Intravenous alteplase 0.9 mg/kg (10% bolus and 90% as IV infusion over 1 hour, maximum 90 mg)\n\nAlteplase: Intravenous alteplase 0.9 mg/kg (10% bolus and 90% as IV infusion over 1 hour, maximum 90 mg)'}], 'classes': [{'categories': [{'measurements': [{'value': '31', 'groupId': 'OG000'}, {'value': '28', 'groupId': 'OG001'}]}]}], 'paramType': 'NUMBER', 'timeFrame': 'within 90 days after fibrinolysis', 'description': 'The number of intracranial hemorrhage (events)', 'unitOfMeasure': 'events', 'reportingStatus': 'POSTED'}, {'type': 'SECONDARY', 'title': 'Symptomatic Intracranial Haemorrhage', 'denoms': [{'units': 'Participants', 'counts': [{'value': '168', 'groupId': 'OG000'}, {'value': '168', 'groupId': 'OG001'}]}], 'groups': [{'id': 'OG000', 'title': 'Recombinant Staphylokinase', 'description': 'Lyophilizate for solution making for intravenous injection, 5 mg (745000 ME). 10 mg of drug reconstituted in 10 ml of 0.9% solution of NaCl given as single i.v. bolus over 5 - 10 seconds\n\nRecombinant staphylokinase: 10 mg of drug reconstituted in 10 ml of 0.9% solution of NaCl given as single i.v. bolus over 5 - 10 seconds'}, {'id': 'OG001', 'title': 'Actilyse', 'description': 'Intravenous alteplase 0.9 mg/kg (10% bolus and 90% as IV infusion over 1 hour, maximum 90 mg)\n\nAlteplase: Intravenous alteplase 0.9 mg/kg (10% bolus and 90% as IV infusion over 1 hour, maximum 90 mg)'}], 'classes': [{'categories': [{'measurements': [{'value': '5', 'groupId': 'OG000'}, {'value': '13', 'groupId': 'OG001'}]}]}], 'paramType': 'NUMBER', 'timeFrame': 'within 90 days after fibrinolysis', 'description': 'The number of symptomatic intracranial haemorrhage according to ECASS III definition (events). The ECASS III definition of symptomatic intracranial haemorrhage was any haemorrhage with neurologic deterioration, as indicated by an NIHSS score that was higher by 4 points or more than the value at baseline or the lowest value in the first 7 days, or any haemorrhage leading to death. In addition, the haemorrhage must have been identified as the predominant cause of the neurologic deterioration.', 'unitOfMeasure': 'events', 'reportingStatus': 'POSTED'}]}, 'participantFlowModule': {'groups': [{'id': 'FG000', 'title': 'Recombinant Staphylokinase', 'description': 'Lyophilizate for solution making for intravenous injection, 5 mg (745000 ME). 10 mg of drug reconstituted in 10 ml of 0.9% solution of NaCl given as single i.v. bolus over 5 - 10 seconds\n\nRecombinant staphylokinase: 10 mg of drug reconstituted in 10 ml of 0.9% solution of NaCl given as single i.v. bolus over 5 - 10 seconds'}, {'id': 'FG001', 'title': 'Actilyse', 'description': 'Intravenous alteplase 0.9 mg/kg (10% bolus and 90% as IV infusion over 1 hour, maximum 90 mg)\n\nAlteplase: Intravenous alteplase 0.9 mg/kg (10% bolus and 90% as IV infusion over 1 hour, maximum 90 mg)'}], 'periods': [{'title': 'Overall Study', 'milestones': [{'type': 'STARTED', 'achievements': [{'groupId': 'FG000', 'numSubjects': '168'}, {'groupId': 'FG001', 'numSubjects': '168'}]}, {'type': 'COMPLETED', 'achievements': [{'groupId': 'FG000', 'numSubjects': '168'}, {'groupId': 'FG001', 'numSubjects': '168'}]}, {'type': 'NOT COMPLETED', 'achievements': [{'groupId': 'FG000', 'numSubjects': '0'}, {'groupId': 'FG001', 'numSubjects': '0'}]}]}]}, 'baselineCharacteristicsModule': {'denoms': [{'units': 'Participants', 'counts': [{'value': '168', 'groupId': 'BG000'}, {'value': '168', 'groupId': 'BG001'}, {'value': '336', 'groupId': 'BG002'}]}], 'groups': [{'id': 'BG000', 'title': 'Recombinant Staphylokinase', 'description': 'Lyophilizate for solution making for intravenous injection, 5 mg (745000 ME). 10 mg of drug reconstituted in 10 ml of 0.9% solution of NaCl given as single i.v. bolus over 5 - 10 seconds\n\nRecombinant staphylokinase: 10 mg of drug reconstituted in 10 ml of 0.9% solution of NaCl given as single i.v. bolus over 5 - 10 seconds'}, {'id': 'BG001', 'title': 'Actilyse', 'description': 'Intravenous alteplase 0.9 mg/kg (10% bolus and 90% as IV infusion over 1 hour, maximum 90 mg)\n\nAlteplase: Intravenous alteplase 0.9 mg/kg (10% bolus and 90% as IV infusion over 1 hour, maximum 90 mg)'}, {'id': 'BG002', 'title': 'Total', 'description': 'Total of all reporting groups'}], 'measures': [{'title': 'Age, Categorical', 'classes': [{'denoms': [{'units': 'Participants', 'counts': [{'value': '168', 'groupId': 'BG000'}, {'value': '168', 'groupId': 'BG001'}, {'value': '336', 'groupId': 'BG002'}]}], 'categories': [{'title': '<=18 years', 'measurements': [{'value': '0', 'groupId': 'BG000'}, {'value': '0', 'groupId': 'BG001'}, {'value': '0', 'groupId': 'BG002'}]}, {'title': 'Between 18 and 65 years', 'measurements': [{'value': '84', 'groupId': 'BG000'}, {'value': '80', 'groupId': 'BG001'}, {'value': '164', 'groupId': 'BG002'}]}, {'title': '>=65 years', 'measurements': [{'value': '84', 'groupId': 'BG000'}, {'value': '88', 'groupId': 'BG001'}, {'value': '172', 'groupId': 'BG002'}]}]}], 'paramType': 'COUNT_OF_PARTICIPANTS', 'unitOfMeasure': 'Participants'}, {'title': 'Age, Continuous', 'classes': [{'denoms': [{'units': 'Participants', 'counts': [{'value': '168', 'groupId': 'BG000'}, {'value': '168', 'groupId': 'BG001'}, {'value': '336', 'groupId': 'BG002'}]}], 'categories': [{'measurements': [{'value': '64.4', 'spread': '9.6', 'groupId': 'BG000'}, {'value': '64.6', 'spread': '10.6', 'groupId': 'BG001'}, {'value': '64.5', 'spread': '10.1', 'groupId': 'BG002'}]}]}], 'paramType': 'MEAN', 'unitOfMeasure': 'years', 'dispersionType': 'STANDARD_DEVIATION'}, {'title': 'Sex: Female, Male', 'classes': [{'denoms': [{'units': 'Participants', 'counts': [{'value': '168', 'groupId': 'BG000'}, {'value': '168', 'groupId': 'BG001'}, {'value': '336', 'groupId': 'BG002'}]}], 'categories': [{'title': 'Female', 'measurements': [{'value': '106', 'groupId': 'BG000'}, {'value': '112', 'groupId': 'BG001'}, {'value': '218', 'groupId': 'BG002'}]}, {'title': 'Male', 'measurements': [{'value': '62', 'groupId': 'BG000'}, {'value': '56', 'groupId': 'BG001'}, {'value': '118', 'groupId': 'BG002'}]}]}], 'paramType': 'COUNT_OF_PARTICIPANTS', 'unitOfMeasure': 'Participants'}, {'title': 'Race and Ethnicity Not Collected', 'classes': [{'denoms': [{'units': 'Participants', 'counts': [{'value': '0', 'groupId': 'BG000'}, {'value': '0', 'groupId': 'BG001'}, {'value': '0', 'groupId': 'BG002'}]}], 'categories': [{'measurements': [{'value': '0', 'groupId': 'BG002'}]}]}], 'paramType': 'COUNT_OF_PARTICIPANTS', 'unitOfMeasure': 'Participants', 'populationDescription': 'Race and Ethnicity were not collected from any participant.'}, {'title': 'Region of Enrollment', 'classes': [{'title': 'Russia', 'denoms': [{'units': 'Participants', 'counts': [{'value': '168', 'groupId': 'BG000'}, {'value': '168', 'groupId': 'BG001'}, {'value': '336', 'groupId': 'BG002'}]}], 'categories': [{'measurements': [{'value': '168', 'groupId': 'BG000'}, {'value': '168', 'groupId': 'BG001'}, {'value': '336', 'groupId': 'BG002'}]}]}], 'paramType': 'COUNT_OF_PARTICIPANTS', 'unitOfMeasure': 'Participants'}, {'title': 'Baseline NIHSS score', 'classes': [{'denoms': [{'units': 'Participants', 'counts': [{'value': '168', 'groupId': 'BG000'}, {'value': '168', 'groupId': 'BG001'}, {'value': '336', 'groupId': 'BG002'}]}], 'categories': [{'measurements': [{'value': '11', 'groupId': 'BG000', 'lowerLimit': '8', 'upperLimit': '14'}, {'value': '11', 'groupId': 'BG001', 'lowerLimit': '8', 'upperLimit': '16'}, {'value': '11', 'groupId': 'BG002', 'lowerLimit': '8', 'upperLimit': '15'}]}]}], 'paramType': 'MEDIAN', 'description': 'The median of The National Institutes of Health Stroke Scale (NIHSS), where: 0 - No stroke symptoms, 1-4 - Minor stroke, 5-15 - Moderate stroke, 16-20 - Moderate to severe stroke, 21-42 - Severe stroke.', 'unitOfMeasure': 'score', 'dispersionType': 'INTER_QUARTILE_RANGE'}, {'title': 'Baseline mRS score', 'classes': [{'denoms': [{'units': 'Participants', 'counts': [{'value': '168', 'groupId': 'BG000'}, {'value': '168', 'groupId': 'BG001'}, {'value': '336', 'groupId': 'BG002'}]}], 'categories': [{'measurements': [{'value': '4', 'groupId': 'BG000', 'lowerLimit': '4', 'upperLimit': '5'}, {'value': '4', 'groupId': 'BG001', 'lowerLimit': '4', 'upperLimit': '5'}, {'value': '4', 'groupId': 'BG002', 'lowerLimit': '4', 'upperLimit': '5'}]}]}], 'paramType': 'MEDIAN', 'description': 'The median of The Modified Rankin Scale (mRS): 0 - No symptoms, 1 - No significant disability. All scale is 0 - No symptoms, 1 - No significant disability, 2 - Slight disability, 3 - Moderate disability, 4 - Moderately severe disability, 5 - Severe disability, 6 - Dead.', 'unitOfMeasure': 'score', 'dispersionType': 'INTER_QUARTILE_RANGE'}]}}, 'documentSection': {'largeDocumentModule': {'largeDocs': [{'date': '2016-07-15', 'size': 611908, 'label': 'Study Protocol and Statistical Analysis Plan', 'hasIcf': False, 'hasSap': True, 'filename': 'Prot_SAP_000.pdf', 'typeAbbrev': 'Prot_SAP', 'uploadDate': '2025-02-06T07:14', 'hasProtocol': True}]}}, 'protocolSection': {'designModule': {'phases': ['PHASE3'], 'studyType': 'INTERVENTIONAL', 'designInfo': {'allocation': 'RANDOMIZED', 'maskingInfo': {'masking': 'NONE', 'maskingDescription': 'All eligible patients will be randomized in two equal groups for administration recombinant nonimmunogenic staphylokinase (Fortelyzin) or alteplase (Actilyse) by using "envelope method" of randomization.'}, 'primaryPurpose': 'TREATMENT', 'interventionModel': 'PARALLEL', 'interventionModelDescription': 'All eligible patients will be randomized in two equal groups for administration recombinant nonimmunogenic staphylokinase (Fortelyzin) or alteplase (Actilyse) by using "envelope method" of randomization. It is an open-lable study. Each of agents will be administered no longer then 4,5 hours from symptoms onset. Comparative agent will be administered as prescribed in its instructions. All patients will be examination for 90 days'}, 'enrollmentInfo': {'type': 'ACTUAL', 'count': 336}}, 'statusModule': {'overallStatus': 'COMPLETED', 'startDateStruct': {'date': '2017-03-18', 'type': 'ACTUAL'}, 'expandedAccessInfo': {'hasExpandedAccess': False}, 'statusVerifiedDate': '2025-03', 'completionDateStruct': {'date': '2019-06-20', 'type': 'ACTUAL'}, 'lastUpdateSubmitDate': '2025-03-17', 'studyFirstSubmitDate': '2017-05-10', 'resultsFirstSubmitDate': '2025-02-06', 'studyFirstSubmitQcDate': '2017-05-11', 'lastUpdatePostDateStruct': {'date': '2025-04-02', 'type': 'ACTUAL'}, 'resultsFirstSubmitQcDate': '2025-03-17', 'studyFirstPostDateStruct': {'date': '2017-05-12', 'type': 'ACTUAL'}, 'resultsFirstPostDateStruct': {'date': '2025-04-02', 'type': 'ACTUAL'}, 'primaryCompletionDateStruct': {'date': '2019-03-23', 'type': 'ACTUAL'}}, 'outcomesModule': {'primaryOutcomes': [{'measure': 'Good Functional Recovery', 'timeFrame': 'within 90 days after fibrinolysis', 'description': 'The number of patients with Modified Rankin Scale (mRS) scores 0-1 on day 90 after drug administration, where 0 - No symptoms, 1 - No significant disability. All scale is 0 - No symptoms, 1 - No significant disability, 2 - Slight disability, 3 - Moderate disability, 4 - Moderately severe disability, 5 - Severe disability, 6 - Dead.'}], 'secondaryOutcomes': [{'measure': 'The Number of Patients With Modified Rankin Scale (0-1) + NIHSS (0-1) + Barthel (95-100)', 'timeFrame': 'within 90 days after fibrinolysis', 'description': 'Composite endpoint, included the number of patients reached Modified Rankin scale 0-1 score, NIHSS 0-1 score and Barthel index 95-100.\n\nModified Rankin scale: 0 - No symptoms, 1 - No significant disability, 2 - Slight disability, 3 - Moderate disability, 4 - Moderately severe disability, 5 - Severe disability, 6 - Dead.\n\nThe National Institutes of Health Stroke Scale (NIHSS): 0 - No stroke symptoms, 1-4 - Minor stroke, 5-15 - Moderate stroke, 16-20 - Moderate to severe stroke, 21-42 - Severe stroke.\n\nBarthel index: 80-100 - Independent, 60-79 - Minimally dependent, 40-59 - Partially dependent, 20-39 - Very dependent, \\<20 - Totally dependent.'}, {'measure': 'The Median of NIHSS After 24 Hours', 'timeFrame': 'after 24 hours', 'description': 'The median of The National Institutes of Health Stroke Scale (NIHSS) at 24 h after drug administration, where: 0 - No stroke symptoms, 1-4 - Minor stroke, 5-15 - Moderate stroke, 16-20 - Moderate to severe stroke, 21-42 - Severe stroke.'}, {'measure': 'The Median of NIHSS After 90 Days', 'timeFrame': 'within 90 days after fibrinolysis', 'description': 'The median of The National Institutes of Health Stroke Scale (NIHSS) after 90 days of drug administration, where: 0 - No stroke symptoms, 1-4 - Minor stroke, 5-15 - Moderate stroke, 16-20 - Moderate to severe stroke, 21-42 - Severe stroke.'}, {'measure': 'All Cause Death', 'timeFrame': 'within 90 days after fibrinolysis', 'description': 'Death caused by any event'}, {'measure': 'Intracranial Haemorrhage', 'timeFrame': 'within 90 days after fibrinolysis', 'description': 'The number of intracranial hemorrhage (events)'}, {'measure': 'Symptomatic Intracranial Haemorrhage', 'timeFrame': 'within 90 days after fibrinolysis', 'description': 'The number of symptomatic intracranial haemorrhage according to ECASS III definition (events). The ECASS III definition of symptomatic intracranial haemorrhage was any haemorrhage with neurologic deterioration, as indicated by an NIHSS score that was higher by 4 points or more than the value at baseline or the lowest value in the first 7 days, or any haemorrhage leading to death. In addition, the haemorrhage must have been identified as the predominant cause of the neurologic deterioration.'}]}, 'oversightModule': {'oversightHasDmc': False, 'isFdaRegulatedDrug': False, 'isFdaRegulatedDevice': False}, 'conditionsModule': {'keywords': ['Acute Ischemic Stroke', 'Fibrinolysis', 'Fortelyzin'], 'conditions': ['Ischemic Stroke']}, 'referencesModule': {'references': [{'pmid': '20598969', 'type': 'BACKGROUND', 'citation': 'Armstrong PW, Gershlick A, Goldstein P, Wilcox R, Danays T, Bluhmki E, Van de Werf F; STREAM Steering Committee. The Strategic Reperfusion Early After Myocardial Infarction (STREAM) study. Am Heart J. 2010 Jul;160(1):30-35.e1. doi: 10.1016/j.ahj.2010.04.007.'}, {'pmid': '10220625', 'type': 'BACKGROUND', 'citation': 'Van de Werf F, Cannon CP, Luyten A, Houbracken K, McCabe CH, Berioli S, Bluhmki E, Sarelin H, Wang-Clow F, Fox NL, Braunwald E. Safety assessment of single-bolus administration of TNK tissue-plasminogen activator in acute myocardial infarction: the ASSENT-1 trial. The ASSENT-1 Investigators. Am Heart J. 1999 May;137(5):786-91. doi: 10.1016/s0002-8703(99)70400-x.'}, {'pmid': '10475182', 'type': 'BACKGROUND', 'citation': 'Assessment of the Safety and Efficacy of a New Thrombolytic (ASSENT-2) Investigators; Van De Werf F, Adgey J, Ardissino D, Armstrong PW, Aylward P, Barbash G, Betriu A, Binbrek AS, Califf R, Diaz R, Fanebust R, Fox K, Granger C, Heikkila J, Husted S, Jansky P, Langer A, Lupi E, Maseri A, Meyer J, Mlczoch J, Mocceti D, Myburgh D, Oto A, Paolasso E, Pehrsson K, Seabra-Gomes R, Soares-Piegas L, Sugrue D, Tendera M, Topol E, Toutouzas P, Vahanian A, Verheugt F, Wallentin L, White H. Single-bolus tenecteplase compared with front-loaded alteplase in acute myocardial infarction: the ASSENT-2 double-blind randomised trial. Lancet. 1999 Aug 28;354(9180):716-22. doi: 10.1016/s0140-6736(99)07403-6.'}, {'pmid': '11530146', 'type': 'BACKGROUND', 'citation': 'Assessment of the Safety and Efficacy of a New Thrombolytic Regimen (ASSENT)-3 Investigators. Efficacy and safety of tenecteplase in combination with enoxaparin, abciximab, or unfractionated heparin: the ASSENT-3 randomised trial in acute myocardial infarction. Lancet. 2001 Aug 25;358(9282):605-13. doi: 10.1016/S0140-6736(01)05775-0.'}, {'pmid': '12847070', 'type': 'BACKGROUND', 'citation': 'Wallentin L, Goldstein P, Armstrong PW, Granger CB, Adgey AA, Arntz HR, Bogaerts K, Danays T, Lindahl B, Makijarvi M, Verheugt F, Van de Werf F. Efficacy and safety of tenecteplase in combination with the low-molecular-weight heparin enoxaparin or unfractionated heparin in the prehospital setting: the Assessment of the Safety and Efficacy of a New Thrombolytic Regimen (ASSENT)-3 PLUS randomized trial in acute myocardial infarction. Circulation. 2003 Jul 15;108(2):135-42. doi: 10.1161/01.CIR.0000081659.72985.A8. Epub 2003 Jul 7.'}, {'pmid': '9313600', 'type': 'BACKGROUND', 'citation': 'Vanderschueren S, Dens J, Kerdsinchai P, Desmet W, Vrolix M, De Man F, Van den Heuvel P, Hermans L, Collen D, Van de Werf F. Randomized coronary patency trial of double-bolus recombinant staphylokinase versus front-loaded alteplase in acute myocardial infarction. Am Heart J. 1997 Aug;134(2 Pt 1):213-9. doi: 10.1016/s0002-8703(97)70127-3.'}, {'pmid': '17963623', 'type': 'BACKGROUND', 'citation': 'Collaborative Research Group of Reperfusion Therapy in Acute Myocardial Infarction. [A randomized multicenter trial comparing recombinant staphylokinase with recombinant tissue-type plasminogen activator in patients with acute myocardial infarction]. Zhonghua Xin Xue Guan Bing Za Zhi. 2007 Aug;35(8):691-6. Chinese.'}, {'pmid': '9500599', 'type': 'BACKGROUND', 'citation': 'Collen D. Staphylokinase: a potent, uniquely fibrin-selective thrombolytic agent. Nat Med. 1998 Mar;4(3):279-84. doi: 10.1038/nm0398-279. No abstract available.'}, {'pmid': '18927461', 'type': 'BACKGROUND', 'citation': 'Wahlgren N, Ahmed N, Eriksson N, Aichner F, Bluhmki E, Davalos A, Erila T, Ford GA, Grond M, Hacke W, Hennerici MG, Kaste M, Kohrmann M, Larrue V, Lees KR, Machnig T, Roine RO, Toni D, Vanhooren G; Safe Implementation of Thrombolysis in Stroke-MOnitoring STudy Investigators. Multivariable analysis of outcome predictors and adjustment of main outcome results to baseline data profile in randomized controlled trials: Safe Implementation of Thrombolysis in Stroke-MOnitoring STudy (SITS-MOST). Stroke. 2008 Dec;39(12):3316-22. doi: 10.1161/STROKEAHA.107.510768. Epub 2008 Oct 16.'}, {'pmid': '9788453', 'type': 'BACKGROUND', 'citation': 'Hacke W, Kaste M, Fieschi C, von Kummer R, Davalos A, Meier D, Larrue V, Bluhmki E, Davis S, Donnan G, Schneider D, Diez-Tejedor E, Trouillas P. Randomised double-blind placebo-controlled trial of thrombolytic therapy with intravenous alteplase in acute ischaemic stroke (ECASS II). Second European-Australasian Acute Stroke Study Investigators. Lancet. 1998 Oct 17;352(9136):1245-51. doi: 10.1016/s0140-6736(98)08020-9.'}, {'pmid': '10591384', 'type': 'BACKGROUND', 'citation': 'Clark WM, Wissman S, Albers GW, Jhamandas JH, Madden KP, Hamilton S. Recombinant tissue-type plasminogen activator (Alteplase) for ischemic stroke 3 to 5 hours after symptom onset. The ATLANTIS Study: a randomized controlled trial. Alteplase Thrombolysis for Acute Noninterventional Therapy in Ischemic Stroke. JAMA. 1999 Dec 1;282(21):2019-26. doi: 10.1001/jama.282.21.2019.'}, {'pmid': '18815396', 'type': 'BACKGROUND', 'citation': 'Hacke W, Kaste M, Bluhmki E, Brozman M, Davalos A, Guidetti D, Larrue V, Lees KR, Medeghri Z, Machnig T, Schneider D, von Kummer R, Wahlgren N, Toni D; ECASS Investigators. Thrombolysis with alteplase 3 to 4.5 hours after acute ischemic stroke. N Engl J Med. 2008 Sep 25;359(13):1317-29. doi: 10.1056/NEJMoa0804656.'}, {'pmid': '34418399', 'type': 'DERIVED', 'citation': 'Gusev EI, Martynov MY, Nikonov AA, Shamalov NA, Semenov MP, Gerasimets EA, Yarovaya EB, Semenov AM, Archakov AI, Markin SS; FRIDA Study Group. Non-immunogenic recombinant staphylokinase versus alteplase for patients with acute ischaemic stroke 4.5 h after symptom onset in Russia (FRIDA): a randomised, open label, multicentre, parallel-group, non-inferiority trial. Lancet Neurol. 2021 Sep;20(9):721-728. doi: 10.1016/S1474-4422(21)00210-6.'}], 'seeAlsoLinks': [{'url': 'http://www.ich.org/products/guidelines/efficacy/article/efficacy-guidelines.html', 'label': 'Efficacy Guidelines. The work carried out by ICH under the Efficacy heading is concerned with the design, conduct, safety and reporting of clinical trials.'}]}, 'descriptionModule': {'briefSummary': 'The aim of the study is to determine if single-bolus recombinant nonimmunogenic staphylokinase is effective and save thrombolytic agent in patients with ischemic stroke in comparison to alteplase.', 'detailedDescription': 'Experimental Drug Profile. The active substance of Fortelyzin is Forteplase. It\'s recombinant protein which contains aminoacid sequence of staphylokinase. It is single chain molecula, consists of 138 aminoacids, weight 15.5 kDa. When staphylokinase is added to human plasma containing a fibrin clot, it preferentially reacts with plasmin at the clot surface, forming a plasmin-staphylokinase complex. This complex activates plasminogen trapped in the thrombus. The plasmin-staphylokinase complex and plasmin bound to fibrin are protected from inhibition by alpha2-antiplasmin. Once liberated from the clot (or generated in plasma), however, they are rapidly inhibited by alpha2-antiplasmin. This selectivity of action confines the process of plasminogen activation to the thrombus, preventing excessive plasmin generation, alpha2-antiplasmin depletion, and fibrinogen degradation in plasma. In rabbits anti forteplase antibodies are not produced. It was achieved by replacement of amino acids in immunogenic epitop of molecule staphylokinase. Blood fibrinogen decrease after i.v. injection of Fortelyzin less 10% within first 24 hours. Angiographic data suggests that restoration of coronary blood flow appears in up to 80% of patients with STEMI after i.v. injection of Fortelyzin.\n\nMain goals of the study are to prove an efficacy of the single-bolus intravenous injection of recombinant nonimmunogenic staphylokinase (Fortelyzin) in comparison with bolus infusion alteplase(Actilyse) in patients with ischemic stroke.\n\nTo prove a safety and to assess possible adverse events in the single-bolus intravenous injection of recombinant nonimmunogenic staphylokinase (Fortelyzin) in comparison with bolus infusion alteplase (Actilyse) in patients with ischemic stroke.\n\nStudy Design. All eligible patients will be randomized in two equal groups for administration recombinant nonimmunogenic staphylokinase (Fortelyzin) or alteplase (Actilyse) by using "envelope method" of randomization. It is an open-lable study. Each of agents will be administered no longer then 4,5 hours from symptoms onset. Comparative agent will be administered as prescribed in its instructions. All patients will be examination for 90 days'}, 'eligibilityModule': {'sex': 'ALL', 'stdAges': ['ADULT', 'OLDER_ADULT'], 'minimumAge': '18 Years', 'healthyVolunteers': False, 'eligibilityCriteria': 'Inclusion Criteria:\n\n* Men and women between the ages of 18 and 80 (Version 1.0)\n* Men and women aged 18 years and older, after 80 years with caution (Version 2.0)\n* Verified diagnosis of ischemic stroke (from 5 to 25 points on the NIHSS scale). (Version 1.0)\n* Verified diagnosis of ischemic stroke (Version 2.0)\n* The time from the onset of the disease is no more than 4.5 hours.\n* Informed consent received\n\nExclusion Criteria:\n\n* The time of the onset of the first symptoms is more than 4.5 hours from the onset of the disease or the time of the onset of the first symptoms of a stroke is not known (for example, the development of a stroke during sleep - the so-called "night stroke").\n* Increased sensitivity to alteplase, gentamicin (residual traces from the production process).\n* Systolic blood pressure above 185 mm Hg. Art. Or diastolic blood pressure above 110 mm Hg. Art. Or the need for / in the administration of drugs to reduce blood pressure to these boundaries.\n* Neuroimaging (CT, MRI) signs of intracranial hemorrhage, brain tumors, arteriovenous malformation, brain abscess, aneurysm of cerebral vessels.\n* Surgery on the brain or spinal cord.\n* Suspicion of subarachnoid hemorrhage.\n* Signs of severe stroke: clinical signs (stroke scale NIH\\> 25), neuroimaging (according to CT of the brain and / or MRI of the brain in the DWI, the ischemia focuses on the territory of more than 1/3 of the CMA pool).\n* Simultaneous reception of oral anticoagulants, for example, warfarin with INR\\> 1.3.\n* The use of direct anticoagulants (heparin, heparinoids) in the preceding stroke of 48 h with APTT values above the norm.\n* Prior stroke or severe head injury within 3 months.\n* Significant regression of neurological symptoms during the observation of the patient.(Version 1.0)\n* Light neurological symptoms (NIH \\<4 points). (Version 1.0)\n* Significant regression of neurological symptoms during the observation of the patient before thrombolisis (Version 2.0)\n* Hemorrhagic stroke or stroke, unspecified in history.\n* Strokes of any genesis in the history of a patient with diabetes mellitus.\n* Gastrointestinal bleeding or bleeding from the genitourinary system in the last 3 weeks. Confirmed exacerbations of gastric ulcer and duodenal ulcer during the last 3 months.\n* Extensive bleeding now or within the previous 6 months.\n* Severe liver disease, including liver failure, cirrhosis, portal hypertension (with varicose veins of the esophagus), active hepatitis.\n* Acute pancreatitis.\n* Bacterial endocarditis, pericarditis.\n* Aneurysms of arteries, malformations of arteries and veins. Suspicion of exfoliating aortic aneurysm.\n* Neoplasms with an increased risk of bleeding.\n* Large operations or severe injuries within the last 14 days, minor surgery or invasive manipulation in the last 10 days.\n* Puncture of uncompensated arteries and veins during the last 7 days.\n* Prolonged or traumatic cardiopulmonary resuscitation (more than 2 min).\n* Pregnancy, obstetrics, 10 days after birth.\n* The number of platelets is less than 100,000 / μL.\n* Blood glucose less than 2.7 mmol / l or more than 22.0 mmol / l.\n* Hemorrhagic diathesis, including renal and hepatic insufficiency.\n* Data on bleeding or acute trauma (fracture) at the time of examination.\n* Seizures in the onset of the disease, if there is no certainty that the seizure is a clinical manifestation of ischemic stroke with a postictal residual deficiency.'}, 'identificationModule': {'nctId': 'NCT03151993', 'briefTitle': 'Single Bolus Recombinant Nonimmunogenic Staphylokinase (Fortelyzin) and Bolus Infusion Alteplase in Patients With AIS', 'organization': {'class': 'INDUSTRY', 'fullName': 'Supergene, LLC'}, 'officialTitle': 'Multicenter Open Label Randomized Comparative Study of Efficacy and Safety of Single Bolus Injection of Recombinant Nonimmunogenic Staphylokinase (Fortelyzin) and Bolus Infusion Alteplase (Actilyse) in Patients With Acute Ischemic Stroke', 'orgStudyIdInfo': {'id': 'FRIDA Stroke Trial'}}, 'armsInterventionsModule': {'armGroups': [{'type': 'EXPERIMENTAL', 'label': 'Recombinant staphylokinase', 'description': 'Lyophilizate for solution making for intravenous injection, 5 mg (745000 ME). 10 mg of drug reconstituted in 10 ml of 0.9% solution of NaCl given as single i.v. bolus over 5 - 10 seconds', 'interventionNames': ['Drug: Recombinant staphylokinase']}, {'type': 'ACTIVE_COMPARATOR', 'label': 'Actilyse', 'description': 'Intravenous alteplase 0.9 mg/kg (10% bolus and 90% as IV infusion over 1 hour, maximum 90 mg)', 'interventionNames': ['Drug: Alteplase']}], 'interventions': [{'name': 'Recombinant staphylokinase', 'type': 'DRUG', 'otherNames': ['Fortelyzin'], 'description': '10 mg of drug reconstituted in 10 ml of 0.9% solution of NaCl given as single i.v. bolus over 5 - 10 seconds', 'armGroupLabels': ['Recombinant staphylokinase']}, {'name': 'Alteplase', 'type': 'DRUG', 'otherNames': ['Actilyse'], 'description': 'Intravenous alteplase 0.9 mg/kg (10% bolus and 90% as IV infusion over 1 hour, maximum 90 mg)', 'armGroupLabels': ['Actilyse']}]}, 'contactsLocationsModule': {'locations': [{'zip': '656024', 'city': 'Barnaul', 'country': 'Russia', 'facility': 'Regional Clinical Hospital', 'geoPoint': {'lat': 53.36199, 'lon': 83.72786}}, {'zip': '308007', 'city': 'Belgorod', 'country': 'Russia', 'facility': "St.Iosaf's Belgorod Regional Clinical Hospital", 'geoPoint': {'lat': 50.60343, 'lon': 36.58091}}, {'zip': '454021', 'city': 'Chelyabinsk', 'country': 'Russia', 'facility': 'Regional Clinical Hospital №3', 'geoPoint': {'lat': 55.1611, 'lon': 61.42877}}, {'zip': '664079', 'city': 'Irkutsk', 'country': 'Russia', 'facility': 'Regional Clinical Hospital', 'geoPoint': {'lat': 52.29566, 'lon': 104.29076}}, {'zip': '248007', 'city': 'Kaluga', 'country': 'Russia', 'facility': 'Regional Clinical Hospital', 'geoPoint': {'lat': 54.53063, 'lon': 36.27}}, {'zip': '350086', 'city': 'Krasnodar', 'country': 'Russia', 'facility': 'Ochapowski Regional Hospital №1', 'geoPoint': {'lat': 45.04534, 'lon': 38.98178}}, {'zip': '305007', 'city': 'Kursk', 'country': 'Russia', 'facility': 'Regional Clinical Hospital', 'geoPoint': {'lat': 51.72689, 'lon': 36.18457}}, {'zip': '603126', 'city': 'Nizhny Novgorod', 'country': 'Russia', 'facility': 'Regional Clinical Hospital', 'geoPoint': {'lat': 56.32867, 'lon': 44.00205}}, {'zip': '460018', 'city': 'Orenburg', 'country': 'Russia', 'facility': 'Regional Clinical Hospital', 'geoPoint': {'lat': 51.76712, 'lon': 55.09883}}, {'zip': '390000', 'city': 'Ryazan', 'country': 'Russia', 'facility': 'City Clinical Hospital №11', 'geoPoint': {'lat': 54.62696, 'lon': 39.70415}}, {'zip': '390039', 'city': 'Ryazan', 'country': 'Russia', 'facility': 'Regional Clinical Hospital', 'geoPoint': {'lat': 54.62696, 'lon': 39.70415}}, {'zip': '194291', 'city': 'Saint Petersburg', 'country': 'Russia', 'facility': 'Regional Clinical Hospital', 'geoPoint': {'lat': 59.93863, 'lon': 30.31413}}, {'zip': '443095', 'city': 'Samara', 'country': 'Russia', 'facility': 'Regional Clinical Hospital', 'geoPoint': {'lat': 53.20767, 'lon': 50.13553}}, {'zip': '170036', 'city': "Tver'", 'country': 'Russia', 'facility': 'Regional Clinical Hospital', 'geoPoint': {'lat': 56.85836, 'lon': 35.90057}}, {'zip': '432017', 'city': 'Ulyanovsk', 'country': 'Russia', 'facility': 'Regional Clinical Hospital', 'geoPoint': {'lat': 54.32824, 'lon': 48.38657}}, {'zip': '400138', 'city': 'Volgograd', 'country': 'Russia', 'facility': 'City Clinical Hospital of Emergency №25', 'geoPoint': {'lat': 48.71378, 'lon': 44.4976}}, {'zip': '394066', 'city': 'Voronezh', 'country': 'Russia', 'facility': 'Regional Clinical Hospital №1', 'geoPoint': {'lat': 51.66833, 'lon': 39.19204}}, {'zip': '620014', 'city': 'Yekaterinburg', 'country': 'Russia', 'facility': 'Regional Clinical Hospital №1', 'geoPoint': {'lat': 56.85733, 'lon': 60.61529}}], 'overallOfficials': [{'name': 'Evgenii I Gusev, MD, PhD', 'role': 'PRINCIPAL_INVESTIGATOR', 'affiliation': 'Pirogov Russian National Research Medical University'}, {'name': 'Sergey S Markin, MD, PhD', 'role': 'STUDY_DIRECTOR', 'affiliation': 'Supergene, LLC'}]}, 'ipdSharingStatementModule': {'ipdSharing': 'NO'}, 'sponsorCollaboratorsModule': {'leadSponsor': {'name': 'Supergene, LLC', 'class': 'INDUSTRY'}, 'responsibleParty': {'type': 'SPONSOR'}}}}