Ignite Creation Date:
2025-12-25 @ 4:19 AM
Ignite Modification Date:
2025-12-26 @ 3:21 AM
Study NCT ID:
NCT04688320
Status:
COMPLETED
Last Update Posted:
2025-04-02
First Post:
2020-12-18
Is NOT Gene Therapy:
False
Has Adverse Events:
True
Brief Title:
Massive Pulmonary Embolism: Trial of Non-immunogenic Recombinant Staphylokinase VS Alteplase FORPE
Sponsor:
Organization:
Raw JSON
{'hasResults': True, 'derivedSection': {'miscInfoModule': {'versionHolder': '2025-12-24'}, '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': 'info@supergene.ru', 'phone': '(495) 287-98-07', 'title': 'Dr. Sergey Markin', 'phoneExt': '+7', 'organization': 'LLC "SuperGene"'}, 'certainAgreement': {'piSponsorEmployee': False, 'restrictiveAgreement': False}}, 'adverseEventsModule': {'timeFrame': '30 days.', 'description': 'Death from all causes; Recurrent PE; Haemodynamic collapse; Ischaemic stroke; Haemorrhagic stroke; Cerebral oedema; Brainstem damage; Haematoma of the thigh; Pulmonary haemorrhage.', 'eventGroups': [{'id': 'EG000', 'title': 'Recombinant Nonimmunogenic Staphylokinase', 'description': 'lyophilisate for preparation of a solution for intravenous administration, 5 mg (745,000 IU) complete with a solvent. 15 mg (2,235,000 IU) - 3 vials, intravenously as a quick single bolus injection for 10-15 seconds, regardless of body weight.\n\nRecombinant nonimmunogenic staphylokinase: 15 mg of drug reconstituted in 10 ml of 0.9% solution of NaCl given as single i.v. bolus over 10-15 seconds', 'otherNumAtRisk': 155, 'deathsNumAtRisk': 145, 'otherNumAffected': 72, 'seriousNumAtRisk': 145, 'deathsNumAffected': 6, 'seriousNumAffected': 9}, {'id': 'EG001', 'title': 'Alteplase', 'description': 'Alteplase® is administered in accordance with the instructions for use for pulmonary embolism( 10 mg bolus and 90 mg as IV infusion over 2 hours, maximum 100 mg). In patients weighing less than 65 kg, the total dose should not exceed 1.5 mg / kg.\n\nAlteplase: Alteplase® is administered in accordance with the instructions for use for pulmonary embolism ( 10 mg bolus and 90 mg as IV infusion over 2 hours, maximum 100 mg). In patients weighing less than 65 kg, the total dose should not exceed 1.5 mg / kg.', 'otherNumAtRisk': 155, 'deathsNumAtRisk': 146, 'otherNumAffected': 86, 'seriousNumAtRisk': 146, 'deathsNumAffected': 4, 'seriousNumAffected': 17}], 'otherEvents': [{'term': 'Hematuria', 'stats': [{'groupId': 'EG000', 'numAtRisk': 155, 'numEvents': 72, 'numAffected': 72}, {'groupId': 'EG001', 'numAtRisk': 155, 'numEvents': 86, 'numAffected': 86}], 'organSystem': 'Blood and lymphatic system disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 10.0'}], 'seriousEvents': [{'term': 'Recurrent PE', 'notes': '30 days', 'stats': [{'groupId': 'EG000', 'numAtRisk': 145, 'numEvents': 1, 'numAffected': 1}, {'groupId': 'EG001', 'numAtRisk': 146, 'numEvents': 2, 'numAffected': 2}], 'organSystem': 'Cardiac disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 10.0'}, {'term': 'Haemodynamic collapse', 'notes': '30 days', 'stats': [{'groupId': 'EG000', 'numAtRisk': 145, 'numEvents': 1, 'numAffected': 1}, {'groupId': 'EG001', 'numAtRisk': 146, 'numEvents': 3, 'numAffected': 3}], 'organSystem': 'Cardiac disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 10.0'}, {'term': 'Ischaemic stroke', 'notes': '30 days', 'stats': [{'groupId': 'EG000', 'numAtRisk': 145, 'numEvents': 1, 'numAffected': 1}, {'groupId': 'EG001', 'numAtRisk': 146, 'numEvents': 0, 'numAffected': 0}], 'organSystem': 'Nervous system disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 10.0'}, {'term': 'Haemorrhagic stroke', 'notes': '30 days', 'stats': [{'groupId': 'EG000', 'numAtRisk': 145, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG001', 'numAtRisk': 146, 'numEvents': 3, 'numAffected': 3}], 'organSystem': 'Nervous system disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 10.0'}, {'term': 'Cerebral oedema', 'notes': '30 days', 'stats': [{'groupId': 'EG000', 'numAtRisk': 145, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG001', 'numAtRisk': 146, 'numEvents': 2, 'numAffected': 2}], 'organSystem': 'Nervous system disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 10.0'}, {'term': 'Brainstem damage', 'notes': '30 days', 'stats': [{'groupId': 'EG000', 'numAtRisk': 145, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG001', 'numAtRisk': 146, 'numEvents': 1, 'numAffected': 1}], 'organSystem': 'Nervous system disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 10.0'}, {'term': 'Haematoma of the thigh', 'notes': '30 days', 'stats': [{'groupId': 'EG000', 'numAtRisk': 145, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG001', 'numAtRisk': 146, 'numEvents': 1, 'numAffected': 1}], 'organSystem': 'Cardiac disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 10.0'}, {'term': 'Pulmonary haemorrhage', 'notes': '30 days', 'stats': [{'groupId': 'EG000', 'numAtRisk': 145, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG001', 'numAtRisk': 146, 'numEvents': 1, 'numAffected': 1}], 'organSystem': 'Respiratory, thoracic and mediastinal disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 10.0'}, {'term': 'Death from all causes', 'notes': '30 days', 'stats': [{'groupId': 'EG000', 'numAtRisk': 145, 'numEvents': 6, 'numAffected': 6}, {'groupId': 'EG001', 'numAtRisk': 146, 'numEvents': 4, 'numAffected': 4}], 'organSystem': 'Cardiac disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 10.0'}], 'frequencyThreshold': '1'}, 'outcomeMeasuresModule': {'outcomeMeasures': [{'type': 'PRIMARY', 'title': 'Death From All Causes', 'denoms': [{'units': 'Participants', 'counts': [{'value': '145', 'groupId': 'OG000'}, {'value': '146', 'groupId': 'OG001'}]}], 'groups': [{'id': 'OG000', 'title': 'Recombinant Nonimmunogenic Staphylokinase', 'description': 'lyophilisate for preparation of a solution for intravenous administration, 5 mg (745,000 IU) complete with a solvent. 15 mg (2,235,000 IU) - 3 vials, intravenously as a quick single bolus injection for 10-15 seconds, regardless of body weight.\n\nRecombinant nonimmunogenic staphylokinase: 15 mg of drug reconstituted in 10 ml of 0.9% solution of NaCl given as single i.v. bolus over 10-15 seconds'}, {'id': 'OG001', 'title': 'Alteplase', 'description': 'Alteplase® is administered in accordance with the instructions for use for pulmonary embolism( 10 mg bolus and 90 mg as IV infusion over 2 hours, maximum 100 mg). In patients weighing less than 65 kg, the total dose should not exceed 1.5 mg / kg.\n\nAlteplase: Alteplase® is administered in accordance with the instructions for use for pulmonary embolism ( 10 mg bolus and 90 mg as IV infusion over 2 hours, maximum 100 mg). In patients weighing less than 65 kg, the total dose should not exceed 1.5 mg / kg.'}], 'classes': [{'categories': [{'measurements': [{'value': '3', 'groupId': 'OG000'}, {'value': '4', 'groupId': 'OG001'}]}]}], 'analyses': [{'pValue': '<0.05', 'groupIds': ['OG000', 'OG001'], 'paramType': 'Odds Ratio (OR)', 'ciNumSides': 'TWO_SIDED', 'ciPctValue': '95', 'paramValue': '0.75', 'ciLowerLimit': '0.11', 'ciUpperLimit': '4.52', 'statisticalMethod': "Welch's t-test", 'nonInferiorityType': 'NON_INFERIORITY', 'nonInferiorityComment': 'The margin of the non-inferiority was established as a difference in the primary efficacy endpoints between compared groups'}], 'paramType': 'COUNT_OF_PARTICIPANTS', 'timeFrame': 'within 7 days', 'description': 'The efficacy is evaluated in terms of the number of deaths from all causes', 'unitOfMeasure': 'Participants', 'reportingStatus': 'POSTED', 'populationDescription': 'in the per-protocol population'}, {'type': 'SECONDARY', 'title': 'Systolic Pulmonary Artery Pressure Measures (V1, V2, V4, V5)', 'denoms': [{'units': 'Participants', 'counts': [{'value': '145', 'groupId': 'OG000'}, {'value': '145', 'groupId': 'OG001'}]}], 'groups': [{'id': 'OG000', 'title': 'Recombinant Nonimmunogenic Staphylokinase', 'description': 'lyophilisate for preparation of a solution for intravenous administration, 5 mg (745,000 IU) complete with a solvent. 15 mg (2,235,000 IU) - 3 vials, intravenously as a quick single bolus injection for 10-15 seconds, regardless of body weight.\n\nRecombinant nonimmunogenic staphylokinase: 15 mg of drug reconstituted in 10 ml of 0.9% solution of NaCl given as single i.v. bolus over 10-15 seconds'}, {'id': 'OG001', 'title': 'Alteplase', 'description': 'Alteplase® is administered in accordance with the instructions for use for pulmonary embolism( 10 mg bolus and 90 mg as IV infusion over 2 hours, maximum 100 mg). In patients weighing less than 65 kg, the total dose should not exceed 1.5 mg / kg.\n\nAlteplase: Alteplase® is administered in accordance with the instructions for use for pulmonary embolism ( 10 mg bolus and 90 mg as IV infusion over 2 hours, maximum 100 mg). In patients weighing less than 65 kg, the total dose should not exceed 1.5 mg / kg.'}], 'classes': [{'title': 'PASP on baseline', 'categories': [{'measurements': [{'value': '59', 'groupId': 'OG000', 'lowerLimit': '50', 'upperLimit': '69'}, {'value': '58', 'groupId': 'OG001', 'lowerLimit': '51', 'upperLimit': '69'}]}]}, {'title': 'PASP on day 1', 'categories': [{'measurements': [{'value': '44', 'groupId': 'OG000', 'lowerLimit': '36', 'upperLimit': '52'}, {'value': '42', 'groupId': 'OG001', 'lowerLimit': '36', 'upperLimit': '50'}]}]}, {'title': 'PASP on day 7', 'categories': [{'measurements': [{'value': '36', 'groupId': 'OG000', 'lowerLimit': '31', 'upperLimit': '44'}, {'value': '35', 'groupId': 'OG001', 'lowerLimit': '29', 'upperLimit': '41'}]}]}, {'title': 'PASP on day 14', 'categories': [{'measurements': [{'value': '35', 'groupId': 'OG000', 'lowerLimit': '30', 'upperLimit': '41'}, {'value': '35', 'groupId': 'OG001', 'lowerLimit': '28', 'upperLimit': '41'}]}]}], 'paramType': 'MEDIAN', 'timeFrame': 'baseline and day 1, 7, 14 after randomisation', 'description': 'The efficacy is evaluated in terms of systolic pulmonary artery pressure values', 'unitOfMeasure': 'mm Hg', 'dispersionType': 'Inter-Quartile Range', 'reportingStatus': 'POSTED', 'populationDescription': 'The efficacy is evaluated in terms of decreasing of pulmonary artery systolic pressure (PASP) values on baseline and day 1, 7, 14 after randomisation in the per-protocol population'}, {'type': 'SECONDARY', 'title': 'Haemodynamic Collapse', 'denoms': [{'units': 'Participants', 'counts': [{'value': '145', 'groupId': 'OG000'}, {'value': '146', 'groupId': 'OG001'}]}], 'groups': [{'id': 'OG000', 'title': 'Recombinant Nonimmunogenic Staphylokinase', 'description': 'lyophilisate for preparation of a solution for intravenous administration, 5 mg (745,000 IU) complete with a solvent. 15 mg (2,235,000 IU) - 3 vials, intravenously as a quick single bolus injection for 10-15 seconds, regardless of body weight.\n\nRecombinant nonimmunogenic staphylokinase: 15 mg of drug reconstituted in 10 ml of 0.9% solution of NaCl given as single i.v. bolus over 10-15 seconds'}, {'id': 'OG001', 'title': 'Alteplase', 'description': 'Alteplase® is administered in accordance with the instructions for use for pulmonary embolism( 10 mg bolus and 90 mg as IV infusion over 2 hours, maximum 100 mg). In patients weighing less than 65 kg, the total dose should not exceed 1.5 mg / kg.\n\nAlteplase: Alteplase® is administered in accordance with the instructions for use for pulmonary embolism ( 10 mg bolus and 90 mg as IV infusion over 2 hours, maximum 100 mg). In patients weighing less than 65 kg, the total dose should not exceed 1.5 mg / kg.'}], 'classes': [{'categories': [{'measurements': [{'value': '1', 'groupId': 'OG000'}, {'value': '3', 'groupId': 'OG001'}]}]}], 'paramType': 'NUMBER', 'timeFrame': 'within 7 days', 'description': 'The efficacy is evaluated in terms of the number of haemodynamic collapse', 'unitOfMeasure': 'events', 'reportingStatus': 'POSTED', 'populationDescription': 'The efficacy is evaluated in terms of the number of haemodynamic collapse in the per-protocol population'}, {'type': 'SECONDARY', 'title': 'Recurrent Pulmonary Embolism (PE)', 'denoms': [{'units': 'Participants', 'counts': [{'value': '145', 'groupId': 'OG000'}, {'value': '146', 'groupId': 'OG001'}]}], 'groups': [{'id': 'OG000', 'title': 'Recombinant Nonimmunogenic Staphylokinase', 'description': 'lyophilisate for preparation of a solution for intravenous administration, 5 mg (745,000 IU) complete with a solvent. 15 mg (2,235,000 IU) - 3 vials, intravenously as a quick single bolus injection for 10-15 seconds, regardless of body weight.\n\nRecombinant nonimmunogenic staphylokinase: 15 mg of drug reconstituted in 10 ml of 0.9% solution of NaCl given as single i.v. bolus over 10-15 seconds'}, {'id': 'OG001', 'title': 'Alteplase', 'description': 'Alteplase® is administered in accordance with the instructions for use for pulmonary embolism( 10 mg bolus and 90 mg as IV infusion over 2 hours, maximum 100 mg). In patients weighing less than 65 kg, the total dose should not exceed 1.5 mg / kg.\n\nAlteplase: Alteplase® is administered in accordance with the instructions for use for pulmonary embolism ( 10 mg bolus and 90 mg as IV infusion over 2 hours, maximum 100 mg). In patients weighing less than 65 kg, the total dose should not exceed 1.5 mg / kg.'}], 'classes': [{'categories': [{'measurements': [{'value': '1', 'groupId': 'OG000'}, {'value': '2', 'groupId': 'OG001'}]}]}], 'paramType': 'NUMBER', 'timeFrame': 'within 7 days', 'description': 'The efficacy is evaluated in terms of the number of recurrent PE', 'unitOfMeasure': 'events', 'reportingStatus': 'POSTED', 'populationDescription': 'The efficacy is evaluated in terms of the number of recurrent PE in the per-protocol population'}, {'type': 'SECONDARY', 'title': 'Death From PE', 'denoms': [{'units': 'Participants', 'counts': [{'value': '145', 'groupId': 'OG000'}, {'value': '146', 'groupId': 'OG001'}]}], 'groups': [{'id': 'OG000', 'title': 'Recombinant Nonimmunogenic Staphylokinase', 'description': 'lyophilisate for preparation of a solution for intravenous administration, 5 mg (745,000 IU) complete with a solvent. 15 mg (2,235,000 IU) - 3 vials, intravenously as a quick single bolus injection for 10-15 seconds, regardless of body weight.\n\nRecombinant nonimmunogenic staphylokinase: 15 mg of drug reconstituted in 10 ml of 0.9% solution of NaCl given as single i.v. bolus over 10-15 seconds'}, {'id': 'OG001', 'title': 'Alteplase', 'description': 'Alteplase® is administered in accordance with the instructions for use for pulmonary embolism( 10 mg bolus and 90 mg as IV infusion over 2 hours, maximum 100 mg). In patients weighing less than 65 kg, the total dose should not exceed 1.5 mg / kg.\n\nAlteplase: Alteplase® is administered in accordance with the instructions for use for pulmonary embolism ( 10 mg bolus and 90 mg as IV infusion over 2 hours, maximum 100 mg). In patients weighing less than 65 kg, the total dose should not exceed 1.5 mg / kg.'}], 'classes': [{'categories': [{'measurements': [{'value': '4', 'groupId': 'OG000'}, {'value': '2', 'groupId': 'OG001'}]}]}], 'paramType': 'COUNT_OF_PARTICIPANTS', 'timeFrame': 'within 30 days', 'description': 'The efficacy is evaluated in terms of the number of deaths from PE', 'unitOfMeasure': 'Participants', 'reportingStatus': 'POSTED', 'populationDescription': 'The efficacy is evaluated in terms of the number of deaths from PE in the per-protocol population'}, {'type': 'SECONDARY', 'title': 'Death From All Causes', 'denoms': [{'units': 'Participants', 'counts': [{'value': '145', 'groupId': 'OG000'}, {'value': '146', 'groupId': 'OG001'}]}], 'groups': [{'id': 'OG000', 'title': 'Recombinant Nonimmunogenic Staphylokinase', 'description': 'lyophilisate for preparation of a solution for intravenous administration, 5 mg (745,000 IU) complete with a solvent. 15 mg (2,235,000 IU) - 3 vials, intravenously as a quick single bolus injection for 10-15 seconds, regardless of body weight.\n\nRecombinant nonimmunogenic staphylokinase: 15 mg of drug reconstituted in 10 ml of 0.9% solution of NaCl given as single i.v. bolus over 10-15 seconds'}, {'id': 'OG001', 'title': 'Alteplase', 'description': 'Alteplase® is administered in accordance with the instructions for use for pulmonary embolism( 10 mg bolus and 90 mg as IV infusion over 2 hours, maximum 100 mg). In patients weighing less than 65 kg, the total dose should not exceed 1.5 mg / kg.\n\nAlteplase: Alteplase® is administered in accordance with the instructions for use for pulmonary embolism ( 10 mg bolus and 90 mg as IV infusion over 2 hours, maximum 100 mg). In patients weighing less than 65 kg, the total dose should not exceed 1.5 mg / kg.'}], 'classes': [{'categories': [{'measurements': [{'value': '6', 'groupId': 'OG000'}, {'value': '4', 'groupId': 'OG001'}]}]}], 'paramType': 'COUNT_OF_PARTICIPANTS', 'timeFrame': 'within 30 days', 'description': 'The efficacy is evaluated in terms of the number of deaths from all causes', 'unitOfMeasure': 'Participants', 'reportingStatus': 'POSTED', 'populationDescription': 'The efficacy is evaluated in terms of the number of deaths from all causes in the per-protocol population'}, {'type': 'SECONDARY', 'title': 'Haemodynamic Collapse Within 7 Days + Recurrent PE Within 7 Days + Death From All Causes Within 30 Days', 'denoms': [{'units': 'Participants', 'counts': [{'value': '145', 'groupId': 'OG000'}, {'value': '146', 'groupId': 'OG001'}]}], 'groups': [{'id': 'OG000', 'title': 'Recombinant Nonimmunogenic Staphylokinase', 'description': 'lyophilisate for preparation of a solution for intravenous administration, 5 mg (745,000 IU) complete with a solvent. 15 mg (2,235,000 IU) - 3 vials, intravenously as a quick single bolus injection for 10-15 seconds, regardless of body weight.\n\nRecombinant nonimmunogenic staphylokinase: 15 mg of drug reconstituted in 10 ml of 0.9% solution of NaCl given as single i.v. bolus over 10-15 seconds'}, {'id': 'OG001', 'title': 'Alteplase', 'description': 'Alteplase® is administered in accordance with the instructions for use for pulmonary embolism( 10 mg bolus and 90 mg as IV infusion over 2 hours, maximum 100 mg). In patients weighing less than 65 kg, the total dose should not exceed 1.5 mg / kg.\n\nAlteplase: Alteplase® is administered in accordance with the instructions for use for pulmonary embolism ( 10 mg bolus and 90 mg as IV infusion over 2 hours, maximum 100 mg). In patients weighing less than 65 kg, the total dose should not exceed 1.5 mg / kg.'}], 'classes': [{'categories': [{'measurements': [{'value': '8', 'groupId': 'OG000'}, {'value': '9', 'groupId': 'OG001'}]}]}], 'paramType': 'NUMBER', 'timeFrame': 'within 30 days', 'description': 'The efficacy is evaluated in terms of the number of haemodynamic collapse + recurrent PE + deaths from all causes', 'unitOfMeasure': 'events', 'reportingStatus': 'POSTED', 'populationDescription': 'The efficacy is evaluated in terms of the number of haemodynamic collapse + recurrent PE + deaths from all causes within 30 days in the per-protocol population'}, {'type': 'SECONDARY', 'title': 'Safety Endpoint - Haemorrhagic Stroke', 'denoms': [{'units': 'Participants', 'counts': [{'value': '145', 'groupId': 'OG000'}, {'value': '146', 'groupId': 'OG001'}]}], 'groups': [{'id': 'OG000', 'title': 'Recombinant Nonimmunogenic Staphylokinase', 'description': 'lyophilisate for preparation of a solution for intravenous administration, 5 mg (745,000 IU) complete with a solvent. 15 mg (2,235,000 IU) - 3 vials, intravenously as a quick single bolus injection for 10-15 seconds, regardless of body weight.\n\nRecombinant nonimmunogenic staphylokinase: 15 mg of drug reconstituted in 10 ml of 0.9% solution of NaCl given as single i.v. bolus over 10-15 seconds'}, {'id': 'OG001', 'title': 'Alteplase', 'description': 'Alteplase® is administered in accordance with the instructions for use for pulmonary embolism( 10 mg bolus and 90 mg as IV infusion over 2 hours, maximum 100 mg). In patients weighing less than 65 kg, the total dose should not exceed 1.5 mg / kg.\n\nAlteplase: Alteplase® is administered in accordance with the instructions for use for pulmonary embolism ( 10 mg bolus and 90 mg as IV infusion over 2 hours, maximum 100 mg). In patients weighing less than 65 kg, the total dose should not exceed 1.5 mg / kg.'}], 'classes': [{'categories': [{'measurements': [{'value': '0', 'groupId': 'OG000'}, {'value': '3', 'groupId': 'OG001'}]}]}], 'paramType': 'NUMBER', 'timeFrame': 'within 7 days', 'description': 'The safety is evaluated in terms of the number of haemorrhagic stroke within 7 days of randomisation', 'unitOfMeasure': 'events', 'reportingStatus': 'POSTED', 'populationDescription': 'The safety is evaluated in terms of the number of haemorrhagic stroke within 7 days of randomisation in the per-protocol population'}, {'type': 'SECONDARY', 'title': 'Safety Endpoint - BARC Type 3+5 Bleeding', 'denoms': [{'units': 'Participants', 'counts': [{'value': '145', 'groupId': 'OG000'}, {'value': '146', 'groupId': 'OG001'}]}], 'groups': [{'id': 'OG000', 'title': 'Recombinant Nonimmunogenic Staphylokinase', 'description': 'lyophilisate for preparation of a solution for intravenous administration, 5 mg (745,000 IU) complete with a solvent. 15 mg (2,235,000 IU) - 3 vials, intravenously as a quick single bolus injection for 10-15 seconds, regardless of body weight.\n\nRecombinant nonimmunogenic staphylokinase: 15 mg of drug reconstituted in 10 ml of 0.9% solution of NaCl given as single i.v. bolus over 10-15 seconds'}, {'id': 'OG001', 'title': 'Alteplase', 'description': 'Alteplase® is administered in accordance with the instructions for use for pulmonary embolism( 10 mg bolus and 90 mg as IV infusion over 2 hours, maximum 100 mg). In patients weighing less than 65 kg, the total dose should not exceed 1.5 mg / kg.\n\nAlteplase: Alteplase® is administered in accordance with the instructions for use for pulmonary embolism ( 10 mg bolus and 90 mg as IV infusion over 2 hours, maximum 100 mg). In patients weighing less than 65 kg, the total dose should not exceed 1.5 mg / kg.'}], 'classes': [{'categories': [{'measurements': [{'value': '0', 'groupId': 'OG000'}, {'value': '5', 'groupId': 'OG001'}]}]}], 'paramType': 'NUMBER', 'timeFrame': 'within 30 days', 'description': 'The safety is evaluated in terms of the number of BARC type 3+5 bleeding. Type 3a: overt bleeding plus a hemoglobin drop of 3 to 5 g/dL; any transfusion with overt bleeding.\n\nType 3b: overt bleeding plus a hemoglobin drop of 5 g/dL; cardiac tamponade; bleeding requiring surgical intervention for control; bleeding requiring intravenous vasoactive agents.\n\nType 3c: intracranial hemorrhage (does not include microbleeds or hemorrhagic transformation, does include intraspinal); subcategories confirmed by autopsy or imaging, or lumbar puncture; intraocular bleed compromising vision.\n\nType 5a: probable fatal bleeding; no autopsy or imaging confirmation but clinically suspicious.\n\nType 5b: definite fatal bleeding; overt bleeding or autopsy, or imaging confirmation.', 'unitOfMeasure': 'events', 'reportingStatus': 'POSTED', 'populationDescription': 'The safety is evaluated in terms of the number of BARC type 3+5 bleeding within 30 days in the per-protocol population'}, {'type': 'SECONDARY', 'title': 'Safety Endpoint - Number and Severity of Serious Adverse Events (SAEs)', 'denoms': [{'units': 'Participants', 'counts': [{'value': '145', 'groupId': 'OG000'}, {'value': '146', 'groupId': 'OG001'}]}], 'groups': [{'id': 'OG000', 'title': 'Recombinant Nonimmunogenic Staphylokinase', 'description': 'lyophilisate for preparation of a solution for intravenous administration, 5 mg (745,000 IU) complete with a solvent. 15 mg (2,235,000 IU) - 3 vials, intravenously as a quick single bolus injection for 10-15 seconds, regardless of body weight.\n\nRecombinant nonimmunogenic staphylokinase: 15 mg of drug reconstituted in 10 ml of 0.9% solution of NaCl given as single i.v. bolus over 10-15 seconds'}, {'id': 'OG001', 'title': 'Alteplase', 'description': 'Alteplase® is administered in accordance with the instructions for use for pulmonary embolism( 10 mg bolus and 90 mg as IV infusion over 2 hours, maximum 100 mg). In patients weighing less than 65 kg, the total dose should not exceed 1.5 mg / kg.\n\nAlteplase: Alteplase® is administered in accordance with the instructions for use for pulmonary embolism ( 10 mg bolus and 90 mg as IV infusion over 2 hours, maximum 100 mg). In patients weighing less than 65 kg, the total dose should not exceed 1.5 mg / kg.'}], 'classes': [{'categories': [{'measurements': [{'value': '9', 'groupId': 'OG000'}, {'value': '17', 'groupId': 'OG001'}]}]}], 'paramType': 'NUMBER', 'timeFrame': 'within 30 days', 'description': 'The safety is evaluated in terms of the number and severity of serious adverse events (SAEs)', 'unitOfMeasure': 'events', 'reportingStatus': 'POSTED', 'populationDescription': 'The safety is evaluated in terms of the number and severity of serious adverse events (SAEs) in the per-protocol population'}]}, 'participantFlowModule': {'groups': [{'id': 'FG000', 'title': 'Recombinant Nonimmunogenic Staphylokinase', 'description': 'lyophilisate for preparation of a solution for intravenous administration, 5 mg (745,000 IU) complete with a solvent. 15 mg (2,235,000 IU) - 3 vials, intravenously as a quick single bolus injection for 10-15 seconds, regardless of body weight.\n\nRecombinant nonimmunogenic staphylokinase: 15 mg of drug reconstituted in 10 ml of 0.9% solution of NaCl given as single i.v. bolus over 10-15 seconds'}, {'id': 'FG001', 'title': 'Alteplase', 'description': 'Alteplase® is administered in accordance with the instructions for use for pulmonary embolism( 10 mg bolus and 90 mg as IV infusion over 2 hours, maximum 100 mg). In patients weighing less than 65 kg, the total dose should not exceed 1.5 mg / kg.\n\nAlteplase: Alteplase® is administered in accordance with the instructions for use for pulmonary embolism ( 10 mg bolus and 90 mg as IV infusion over 2 hours, maximum 100 mg). In patients weighing less than 65 kg, the total dose should not exceed 1.5 mg / kg.'}], 'periods': [{'title': 'Overall Study', 'milestones': [{'type': 'STARTED', 'achievements': [{'groupId': 'FG000', 'numSubjects': '155'}, {'groupId': 'FG001', 'numSubjects': '155'}]}, {'type': 'COMPLETED', 'achievements': [{'groupId': 'FG000', 'numSubjects': '145'}, {'groupId': 'FG001', 'numSubjects': '146'}]}, {'type': 'NOT COMPLETED', 'achievements': [{'groupId': 'FG000', 'numSubjects': '10'}, {'groupId': 'FG001', 'numSubjects': '9'}]}]}]}, 'baselineCharacteristicsModule': {'denoms': [{'units': 'Participants', 'counts': [{'value': '155', 'groupId': 'BG000'}, {'value': '155', 'groupId': 'BG001'}, {'value': '310', 'groupId': 'BG002'}]}], 'groups': [{'id': 'BG000', 'title': 'Recombinant Nonimmunogenic Staphylokinase', 'description': 'lyophilisate for preparation of a solution for intravenous administration, 5 mg (745,000 IU) complete with a solvent. 15 mg (2,235,000 IU) - 3 vials, intravenously as a quick single bolus injection for 10-15 seconds, regardless of body weight.\n\nRecombinant nonimmunogenic staphylokinase: 15 mg of drug reconstituted in 10 ml of 0.9% solution of NaCl given as single i.v. bolus over 10-15 seconds'}, {'id': 'BG001', 'title': 'Alteplase', 'description': 'Alteplase® is administered in accordance with the instructions for use for pulmonary embolism( 10 mg bolus and 90 mg as IV infusion over 2 hours, maximum 100 mg). In patients weighing less than 65 kg, the total dose should not exceed 1.5 mg / kg.\n\nAlteplase: Alteplase® is administered in accordance with the instructions for use for pulmonary embolism ( 10 mg bolus and 90 mg as IV infusion over 2 hours, maximum 100 mg). In patients weighing less than 65 kg, the total dose should not exceed 1.5 mg / kg.'}, {'id': 'BG002', 'title': 'Total', 'description': 'Total of all reporting groups'}], 'measures': [{'title': 'Age, Categorical', 'classes': [{'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': '75', 'groupId': 'BG000'}, {'value': '94', 'groupId': 'BG001'}, {'value': '169', 'groupId': 'BG002'}]}, {'title': '>=65 years', 'measurements': [{'value': '80', 'groupId': 'BG000'}, {'value': '61', 'groupId': 'BG001'}, {'value': '141', 'groupId': 'BG002'}]}]}], 'paramType': 'COUNT_OF_PARTICIPANTS', 'unitOfMeasure': 'Participants'}, {'title': 'Age, Continuous', 'classes': [{'categories': [{'measurements': [{'value': '64', 'spread': '13', 'groupId': 'BG000'}, {'value': '62', 'spread': '13', 'groupId': 'BG001'}, {'value': '63', 'spread': '13', 'groupId': 'BG002'}]}]}], 'paramType': 'MEAN', 'unitOfMeasure': 'years', 'dispersionType': 'STANDARD_DEVIATION'}, {'title': 'Sex: Female, Male', 'classes': [{'categories': [{'title': 'Female', 'measurements': [{'value': '84', 'groupId': 'BG000'}, {'value': '74', 'groupId': 'BG001'}, {'value': '158', 'groupId': 'BG002'}]}, {'title': 'Male', 'measurements': [{'value': '71', 'groupId': 'BG000'}, {'value': '81', 'groupId': 'BG001'}, {'value': '152', 'groupId': 'BG002'}]}]}], 'paramType': 'COUNT_OF_PARTICIPANTS', 'unitOfMeasure': 'Participants'}, {'title': 'Race (NIH/OMB)', 'classes': [{'categories': [{'title': 'American Indian or Alaska Native', 'measurements': [{'value': '0', 'groupId': 'BG000'}, {'value': '0', 'groupId': 'BG001'}, {'value': '0', 'groupId': 'BG002'}]}, {'title': 'Asian', 'measurements': [{'value': '0', 'groupId': 'BG000'}, {'value': '0', 'groupId': 'BG001'}, {'value': '0', 'groupId': 'BG002'}]}, {'title': 'Native Hawaiian or Other Pacific Islander', 'measurements': [{'value': '0', 'groupId': 'BG000'}, {'value': '0', 'groupId': 'BG001'}, {'value': '0', 'groupId': 'BG002'}]}, {'title': 'Black or African American', 'measurements': [{'value': '0', 'groupId': 'BG000'}, {'value': '0', 'groupId': 'BG001'}, {'value': '0', 'groupId': 'BG002'}]}, {'title': 'White', 'measurements': [{'value': '155', 'groupId': 'BG000'}, {'value': '155', 'groupId': 'BG001'}, {'value': '310', 'groupId': 'BG002'}]}, {'title': 'More than one race', 'measurements': [{'value': '0', 'groupId': 'BG000'}, {'value': '0', 'groupId': 'BG001'}, {'value': '0', 'groupId': 'BG002'}]}, {'title': 'Unknown or Not Reported', 'measurements': [{'value': '0', 'groupId': 'BG000'}, {'value': '0', 'groupId': 'BG001'}, {'value': '0', 'groupId': 'BG002'}]}]}], 'paramType': 'COUNT_OF_PARTICIPANTS', 'unitOfMeasure': 'Participants'}, {'title': 'Region of Enrollment', 'classes': [{'title': 'Russia', 'categories': [{'measurements': [{'value': '155', 'groupId': 'BG000'}, {'value': '155', 'groupId': 'BG001'}, {'value': '310', 'groupId': 'BG002'}]}]}], 'paramType': 'NUMBER', 'unitOfMeasure': 'participants'}, {'title': 'Body mass index, kg/m^2', 'classes': [{'categories': [{'measurements': [{'value': '32', 'spread': '6', 'groupId': 'BG000'}, {'value': '31', 'spread': '6', 'groupId': 'BG001'}, {'value': '32', 'spread': '6', 'groupId': 'BG002'}]}]}], 'paramType': 'MEAN', 'unitOfMeasure': 'kg/m^2', 'dispersionType': 'STANDARD_DEVIATION'}, {'title': 'Pulmonary Embolism Severity Index (PESI) score', 'classes': [{'categories': [{'measurements': [{'value': '135', 'groupId': 'BG000', 'lowerLimit': '116', 'upperLimit': '150'}, {'value': '128', 'groupId': 'BG001', 'lowerLimit': '113', 'upperLimit': '145'}, {'value': '132', 'groupId': 'BG002', 'lowerLimit': '115', 'upperLimit': '147'}]}]}], 'paramType': 'MEDIAN', 'description': "Pulmonary embolism severity index (PESI). PESI evaluates the patient's age and mortality risk factors. The minimum score on the PESI scale = the patient's age, the maximum = the patient's age + 230 points. If total PESI score is ≤ 65, patient has a very low risk of mortality; 66-85 score - a low risk of mortality; 86-105 score - an intermediate risk of mortality; 106-125 score - a high risk of mortality; if PESI score \\> 125, patient has a very high risk of mortality.", 'unitOfMeasure': 'score', 'dispersionType': 'INTER_QUARTILE_RANGE'}, {'title': 'PESI class V patients', 'classes': [{'categories': [{'measurements': [{'value': '103', 'groupId': 'BG000'}, {'value': '82', 'groupId': 'BG001'}, {'value': '185', 'groupId': 'BG002'}]}]}], 'paramType': 'COUNT_OF_PARTICIPANTS', 'description': 'Patients, who have pulmonary embolism severity index (PESI) \\> 125 score, considered as a class V, with a very high risk of mortality', 'unitOfMeasure': 'Participants'}, {'title': 'Onset to treatment time', 'classes': [{'categories': [{'measurements': [{'value': '27', 'groupId': 'BG000', 'lowerLimit': '11.8', 'upperLimit': '80.5'}, {'value': '17.1', 'groupId': 'BG001', 'lowerLimit': '8.5', 'upperLimit': '68.5'}, {'value': '22', 'groupId': 'BG002', 'lowerLimit': '9.2', 'upperLimit': '72.5'}]}]}], 'paramType': 'MEDIAN', 'unitOfMeasure': 'h', 'dispersionType': 'INTER_QUARTILE_RANGE'}, {'title': 'Qanadli index', 'classes': [{'categories': [{'measurements': [{'value': '65.8', 'spread': '19.8', 'groupId': 'BG000'}, {'value': '67.8', 'spread': '19.7', 'groupId': 'BG001'}, {'value': '66.2', 'spread': '19.8', 'groupId': 'BG002'}]}]}], 'paramType': 'MEAN', 'description': "To quantify the degree of pulmonary artery obstruction by CTPA, the Qanadli index was calculated, where 0 points means no obstruction, 40 points means complete occlusion of all branches of the pulmonary artery.\n\nThe percentage (%) of pulmonary artery obstruction was calculated by dividing the patient's score by the maximum score (40) and and multiplying the result by 100.", 'unitOfMeasure': '% of pulmonary artery obstruction', 'dispersionType': 'STANDARD_DEVIATION'}, {'title': 'Right ventricle end-diastolic diameter', 'classes': [{'categories': [{'measurements': [{'value': '50', 'groupId': 'BG000', 'lowerLimit': '45', 'upperLimit': '56'}, {'value': '50', 'groupId': 'BG001', 'lowerLimit': '47', 'upperLimit': '55'}, {'value': '50', 'groupId': 'BG002', 'lowerLimit': '46', 'upperLimit': '56'}]}]}], 'paramType': 'MEDIAN', 'unitOfMeasure': 'mm', 'dispersionType': 'INTER_QUARTILE_RANGE'}, {'title': 'Right ventricular/lLeft ventricular end-diastolic diameter', 'classes': [{'categories': [{'measurements': [{'value': '1.39', 'groupId': 'BG000', 'lowerLimit': '1.30', 'upperLimit': '1.52'}, {'value': '1.40', 'groupId': 'BG001', 'lowerLimit': '1.34', 'upperLimit': '1.51'}, {'value': '1.40', 'groupId': 'BG002', 'lowerLimit': '1.32', 'upperLimit': '1.52'}]}]}], 'paramType': 'MEDIAN', 'description': 'Ratio of right ventricular (RV) end-diastolic diameter to left ventricular (LV) end-diastolic diameter', 'unitOfMeasure': 'ratio', 'dispersionType': 'INTER_QUARTILE_RANGE'}, {'title': 'Baseline systolic blood pressure', 'classes': [{'categories': [{'measurements': [{'value': '90', 'groupId': 'BG000', 'lowerLimit': '85', 'upperLimit': '100'}, {'value': '90', 'groupId': 'BG001', 'lowerLimit': '85', 'upperLimit': '100'}, {'value': '90', 'groupId': 'BG002', 'lowerLimit': '85', 'upperLimit': '100'}]}]}], 'paramType': 'MEDIAN', 'unitOfMeasure': 'mm Hg', 'dispersionType': 'INTER_QUARTILE_RANGE'}, {'title': 'Baseline diastolic blood pressure', 'classes': [{'categories': [{'measurements': [{'value': '60', 'groupId': 'BG000', 'lowerLimit': '52', 'upperLimit': '65'}, {'value': '60', 'groupId': 'BG001', 'lowerLimit': '53', 'upperLimit': '69'}, {'value': '60', 'groupId': 'BG002', 'lowerLimit': '53', 'upperLimit': '67'}]}]}], 'paramType': 'MEDIAN', 'unitOfMeasure': 'mm Hg', 'dispersionType': 'INTER_QUARTILE_RANGE'}, {'title': 'Baseline heart rate', 'classes': [{'categories': [{'measurements': [{'value': '110', 'groupId': 'BG000', 'lowerLimit': '90', 'upperLimit': '115'}, {'value': '110', 'groupId': 'BG001', 'lowerLimit': '92', 'upperLimit': '115'}, {'value': '110', 'groupId': 'BG002', 'lowerLimit': '91', 'upperLimit': '115'}]}]}], 'paramType': 'MEDIAN', 'unitOfMeasure': 'beats per min', 'dispersionType': 'INTER_QUARTILE_RANGE'}, {'title': 'Baseline respiratory rate', 'classes': [{'categories': [{'measurements': [{'value': '24', 'groupId': 'BG000', 'lowerLimit': '20', 'upperLimit': '27'}, {'value': '24', 'groupId': 'BG001', 'lowerLimit': '21', 'upperLimit': '26'}, {'value': '24', 'groupId': 'BG002', 'lowerLimit': '21', 'upperLimit': '27'}]}]}], 'paramType': 'MEDIAN', 'unitOfMeasure': 'breaths per min', 'dispersionType': 'INTER_QUARTILE_RANGE'}, {'title': 'Baseline SpO2', 'classes': [{'categories': [{'measurements': [{'value': '89', 'groupId': 'BG000', 'lowerLimit': '88', 'upperLimit': '90'}, {'value': '89', 'groupId': 'BG001', 'lowerLimit': '88', 'upperLimit': '92'}, {'value': '89', 'groupId': 'BG002', 'lowerLimit': '88', 'upperLimit': '91'}]}]}], 'paramType': 'MEDIAN', 'unitOfMeasure': '%', 'dispersionType': 'INTER_QUARTILE_RANGE'}], 'populationDescription': '310 patients were randomly assigned to receive either non-immunogenic staphylokinase (n=155) or alteplase (n=155)'}}, 'documentSection': {'largeDocumentModule': {'largeDocs': [{'date': '2021-04-16', 'size': 775658, 'label': 'Study Protocol and Statistical Analysis Plan', 'hasIcf': False, 'hasSap': True, 'filename': 'Prot_SAP_000.pdf', 'typeAbbrev': 'Prot_SAP', 'uploadDate': '2024-10-25T09:54', 'hasProtocol': True}, {'date': '2018-09-01', 'size': 505112, 'label': 'Informed Consent Form', 'hasIcf': True, 'hasSap': False, 'filename': 'ICF_001.pdf', 'typeAbbrev': 'ICF', 'uploadDate': '2024-10-25T09:14', 'hasProtocol': False}]}}, '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 (Actilize) by using "envelope method" of randomization.'}, 'primaryPurpose': 'TREATMENT', 'interventionModel': 'PARALLEL', 'interventionModelDescription': 'At clinical centers, patients will be equally randomly distributed by the "envelope method" into two groups to receive Fortelizin® or Alteplase®.\n\nThe drugs will be administered after the signed informed consent. Fortelizin® will be administered intravenously at a dose of 15 mg as a single bolus for 10-15 seconds. Alteplase® will be administered in accordance with the instructions for use. All patients will be examination for 30 days.'}, 'enrollmentInfo': {'type': 'ACTUAL', 'count': 310}}, 'statusModule': {'overallStatus': 'COMPLETED', 'startDateStruct': {'date': '2020-12-15', 'type': 'ACTUAL'}, 'expandedAccessInfo': {'hasExpandedAccess': False}, 'statusVerifiedDate': '2025-03', 'completionDateStruct': {'date': '2023-07-27', 'type': 'ACTUAL'}, 'lastUpdateSubmitDate': '2025-03-17', 'studyFirstSubmitDate': '2020-12-18', 'resultsFirstSubmitDate': '2024-10-25', 'studyFirstSubmitQcDate': '2020-12-23', 'lastUpdatePostDateStruct': {'date': '2025-04-02', 'type': 'ACTUAL'}, 'resultsFirstSubmitQcDate': '2025-03-17', 'studyFirstPostDateStruct': {'date': '2020-12-29', 'type': 'ACTUAL'}, 'resultsFirstPostDateStruct': {'date': '2025-04-02', 'type': 'ACTUAL'}, 'primaryCompletionDateStruct': {'date': '2023-07-27', 'type': 'ACTUAL'}}, 'outcomesModule': {'primaryOutcomes': [{'measure': 'Death From All Causes', 'timeFrame': 'within 7 days', 'description': 'The efficacy is evaluated in terms of the number of deaths from all causes'}], 'secondaryOutcomes': [{'measure': 'Systolic Pulmonary Artery Pressure Measures (V1, V2, V4, V5)', 'timeFrame': 'baseline and day 1, 7, 14 after randomisation', 'description': 'The efficacy is evaluated in terms of systolic pulmonary artery pressure values'}, {'measure': 'Haemodynamic Collapse', 'timeFrame': 'within 7 days', 'description': 'The efficacy is evaluated in terms of the number of haemodynamic collapse'}, {'measure': 'Recurrent Pulmonary Embolism (PE)', 'timeFrame': 'within 7 days', 'description': 'The efficacy is evaluated in terms of the number of recurrent PE'}, {'measure': 'Death From PE', 'timeFrame': 'within 30 days', 'description': 'The efficacy is evaluated in terms of the number of deaths from PE'}, {'measure': 'Death From All Causes', 'timeFrame': 'within 30 days', 'description': 'The efficacy is evaluated in terms of the number of deaths from all causes'}, {'measure': 'Haemodynamic Collapse Within 7 Days + Recurrent PE Within 7 Days + Death From All Causes Within 30 Days', 'timeFrame': 'within 30 days', 'description': 'The efficacy is evaluated in terms of the number of haemodynamic collapse + recurrent PE + deaths from all causes'}, {'measure': 'Safety Endpoint - Haemorrhagic Stroke', 'timeFrame': 'within 7 days', 'description': 'The safety is evaluated in terms of the number of haemorrhagic stroke within 7 days of randomisation'}, {'measure': 'Safety Endpoint - BARC Type 3+5 Bleeding', 'timeFrame': 'within 30 days', 'description': 'The safety is evaluated in terms of the number of BARC type 3+5 bleeding. Type 3a: overt bleeding plus a hemoglobin drop of 3 to 5 g/dL; any transfusion with overt bleeding.\n\nType 3b: overt bleeding plus a hemoglobin drop of 5 g/dL; cardiac tamponade; bleeding requiring surgical intervention for control; bleeding requiring intravenous vasoactive agents.\n\nType 3c: intracranial hemorrhage (does not include microbleeds or hemorrhagic transformation, does include intraspinal); subcategories confirmed by autopsy or imaging, or lumbar puncture; intraocular bleed compromising vision.\n\nType 5a: probable fatal bleeding; no autopsy or imaging confirmation but clinically suspicious.\n\nType 5b: definite fatal bleeding; overt bleeding or autopsy, or imaging confirmation.'}, {'measure': 'Safety Endpoint - Number and Severity of Serious Adverse Events (SAEs)', 'timeFrame': 'within 30 days', 'description': 'The safety is evaluated in terms of the number and severity of serious adverse events (SAEs)'}]}, 'oversightModule': {'oversightHasDmc': False, 'isFdaRegulatedDrug': False, 'isFdaRegulatedDevice': False}, 'conditionsModule': {'keywords': ['Massive pulmonary embolism', 'Fibrinolysis', 'Recombinant Non-immunogenic Staphylokinase'], 'conditions': ['Massive Pulmonary Embolism']}, 'referencesModule': {'references': [{'pmid': '40391253', 'type': 'DERIVED', 'citation': 'Leontyev SG, Yarovaya EB, Kutsenko VA, Ivlev OE, Soplenkova AG, Semenov AM, Semenov MP, Ivanov SV, Romashova YA, Markin SS. The Safety of Non-immunogenic Recombinant Staphylokinase in Elderly Patients With Massive Pulmonary Embolism: A Randomized Clinical Trial FORPE. Health Sci Rep. 2025 May 19;8(5):e70826. doi: 10.1002/hsr2.70826. eCollection 2025 May.'}]}, 'descriptionModule': {'briefSummary': 'Objective: to evaluate the efficacy and safety of the Recombinant Non-immunogenic Staphylokinase with its single bolus administration in comparison with the bolus-infusion administration of the Alteplase in patients with massive pulmonary embolism', 'detailedDescription': 'The main goal of treating massive PE is to save the lives of patients by restoring pulmonary perfusion, preventing the development of chronic postembolic pulmonary hypertension and recurrent PE. According to data of clinical trials, with timely initiation of therapy for massive pulmonary embolism, mortality can be significantly reduced.\n\nRecombinant protein which contains aminoacid sequence of staphylokinase - Fortelizin® (the active substance is Forteplase). 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\nThe main objectives of the study: to assess the efficacy, safety and possible adverse events of the drug Recombinant Non-immunogenic Staphylokinase with its single bolus administration in comparison with the bolus-infusion administration of the drug Alteplase® in patients with massive pulmonary embolism.\n\nStudy Design. Multicenter, open-label, randomized, comparative clinical study of non-inferiority study of efficacy and safety in parallel groups. At clinical centers, patients will be equally randomly distributed by the "envelope" method into two groups of 155 patients each (310 people in total, including 10% of those who may have dropped out)to receive Recombinant Non-immunogenic Staphylokinase or Alteplase®.\n\nThe drugs will be administered after the signed informed consent. Recombinant Non-immunogenic Staphylokinase will be administered intravenously at a dose of 15 mg as a single bolus for 10-15 seconds. Alteplase® will be administered in accordance with the instructions for use.\n\nPatients will be monitored for 30 days from the moment of randomization: in the intensive care unit up to 7 days, after it in the hospital until discharge - an average of 14 days and an outpatient visits on the 30th day. The recruitment of patients for the study will be competitive.'}, 'eligibilityModule': {'sex': 'ALL', 'stdAges': ['ADULT', 'OLDER_ADULT'], 'minimumAge': '18 Years', 'healthyVolunteers': False, 'eligibilityCriteria': 'Inclusion Criteria:\n\n* Men and women aged 18 and over\n* Verified diagnosis of massive PE (using MSCT with PA contrast)\n* Signs of overload / dysfunction of the right ventricle (at least one) in combination with persistent arterial hypotension or shock\n* Patient consent to use reliable contraceptive methods throughout the study and for 3 weeks after:\n\n * women who have a negative pregnancy test and use the following contraceptives: intrauterine devices, oral contraceptives, contraceptive patch, prolonged injectable contraceptives, double barrier method of contraception. Women who are not fertile can also take part in the study (documented conditions: hysterectomy, tubal ligation, infertility, menopause for more than 1 year);\n * men using barrier contraception. The study may also involve men who are not fertile (documented conditions: vasectomy, infertility)\n* Availability of signed and dated informed consent of the patient to participate in the study.\n\nExclusion Criteria:\n\n* • Increased risk of bleeding:\n\n * Extensive bleeding at present or within the previous 6 months, hemorrhagic diathesis;\n * Intracranial (including subarachnoid) hemorrhage at present or in history, suspected hemorrhagic stroke;\n * A history of hemorrhagic stroke or stroke of unknown etiology;\n * Ischemic stroke or transient ischemic attack within the last 6 months, except for the current acute ischemic stroke within 4.5 hours;\n * A history of diseases of the central nervous system (including neoplasms, aneurysms, surgery on the brain or spinal cord);\n * Major surgery or major trauma within the previous 3 months, recent traumatic brain injury;\n * Long-term or traumatic cardiopulmonary resuscitation (\\> 2 min), delivery within the previous 10 days, recent puncture of an uncompressible blood vessel (eg, subclavian or jugular vein);\n * Severe liver disease, including liver failure, cirrhosis, portal hypertension (including esophageal varices) and active hepatitis;\n * Confirmed gastric or duodenal ulcer within the last three months;\n * Neoplasm with an increased risk of bleeding;\n * Concurrent administration of oral anticoagulants, for example, warfarin with an INR\\> 1.3;\n * Arterial aneurysms, developmental defects of arteries / veins;\n * Severe uncontrolled arterial hypertension;\n * Acute pancreatitis;\n * Bacterial endocarditis, pericarditis;\n * suspicion of aortic dissecting aneurysm;\n * any other conditions, in the opinion of the doctor, associated with a high risk of bleeding.\n* Lactation, pregnancy\n* Known hypersensitivity to Alteplase, Fortelizin.'}, 'identificationModule': {'nctId': 'NCT04688320', 'briefTitle': 'Massive Pulmonary Embolism: Trial of Non-immunogenic Recombinant Staphylokinase VS Alteplase FORPE', 'organization': {'class': 'INDUSTRY', 'fullName': 'Supergene, LLC'}, 'officialTitle': 'Multicenter, Open Label, Randomized Comparative Trial of the Efficacy and Safety of a Single Bolus Recombinant Non-immunogenic Staphylokinase and Bolus-infusion of Alteplase in Patients With Massive Pulmonary Embolism (FORPE)', 'orgStudyIdInfo': {'id': 'FORPE'}}, 'armsInterventionsModule': {'armGroups': [{'type': 'EXPERIMENTAL', 'label': 'Recombinant nonimmunogenic staphylokinase', 'description': 'lyophilisate for preparation of a solution for intravenous administration, 5 mg (745,000 IU) complete with a solvent. 15 mg (2,235,000 IU) - 3 vials, intravenously as a quick single bolus injection for 10-15 seconds, regardless of body weight.', 'interventionNames': ['Drug: Recombinant nonimmunogenic staphylokinase']}, {'type': 'EXPERIMENTAL', 'label': 'Alteplase', 'description': 'Alteplase® is administered in accordance with the instructions for use for pulmonary embolism( 10 mg bolus and 90 mg as IV infusion over 2 hours, maximum 100 mg). In patients weighing less than 65 kg, the total dose should not exceed 1.5 mg / kg.', 'interventionNames': ['Drug: Alteplase']}], 'interventions': [{'name': 'Recombinant nonimmunogenic staphylokinase', 'type': 'DRUG', 'otherNames': ['Fortelyzin'], 'description': '15 mg of drug reconstituted in 10 ml of 0.9% solution of NaCl given as single i.v. bolus over 10-15 seconds', 'armGroupLabels': ['Recombinant nonimmunogenic staphylokinase']}, {'name': 'Alteplase', 'type': 'DRUG', 'otherNames': ['Actillyze'], 'description': 'Alteplase® is administered in accordance with the instructions for use for pulmonary embolism ( 10 mg bolus and 90 mg as IV infusion over 2 hours, maximum 100 mg). In patients weighing less than 65 kg, the total dose should not exceed 1.5 mg / kg.', 'armGroupLabels': ['Alteplase']}]}, 'contactsLocationsModule': {'locations': [{'zip': '353100', 'city': 'Vyselki', 'state': 'Krasnodarskiy Kray', 'country': 'Russia', 'facility': 'V.F. Dolgopolov Vyselki Central District Hospital', 'geoPoint': {'lat': 45.58058, 'lon': 39.65741}}, {'zip': '141301', 'city': 'Sergiyev Posad', 'state': 'Moscow Oblast', 'country': 'Russia', 'facility': 'Sergiyev Posad Regional Clinical Hospital', 'geoPoint': {'lat': 56.31204, 'lon': 38.13869}}, {'zip': '308007', 'city': 'Belgorod', 'country': 'Russia', 'facility': 'Belgorod Regional Clinical Hospital of St. Joseph', 'geoPoint': {'lat': 50.60343, 'lon': 36.58091}}, {'zip': '650002', 'city': 'Kemerovo', 'country': 'Russia', 'facility': 'Kuzbass Cardiology center', 'geoPoint': {'lat': 55.35417, 'lon': 86.10435}}, {'zip': '660022', 'city': 'Krasnoyarsk', 'country': 'Russia', 'facility': 'Krasnoyarsk Regional Clinical Hospital', 'geoPoint': {'lat': 56.03742, 'lon': 92.93136}}, {'zip': '305007', 'city': 'Kursk', 'country': 'Russia', 'facility': 'Kursk Regional Clinical Hospital', 'geoPoint': {'lat': 51.72689, 'lon': 36.18457}}, {'zip': '105077', 'city': 'Moscow', 'country': 'Russia', 'facility': 'D.D. 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