[{"data":1,"prerenderedAt":-1},["ShallowReactive",2],{"health-study-detail:100611849":3},{"organization":4,"armGroups":7,"interventions":14,"overallOfficials":22,"centralContacts":27,"locations":33,"responsibleParty":54,"collaborators":56,"id":60,"slug":61,"hasResults":62,"nctId":63,"briefTitle":64,"officialTitle":65,"acronym":10,"eligibilityCriteria":66,"healthyVolunteers":62,"sex":67,"minAge":68,"maxAge":10,"enrollmentInfo":69,"targetDuration":10,"studyType":72,"phases":10,"briefSummary":73,"conditions":74,"keywords":76,"overallStatus":36,"whyStopped":10,"lastUpdateSubmitDate":78,"lastUpdatePostDateStruct":79,"startDateStruct":82,"completionDateStruct":84,"leadSponsor":86,"locationsCount":87},{"fullName":5,"class":6},"Supergene, LLC","INDUSTRY",[8],{"label":9,"type":10,"description":11,"interventionNames":12},"Non-immunogenic staphylokinase",null,"Drug: non-immunogenic staphylokinase 15 mg as a single intravenous bolus Other Names: Fortelyzin®",[13],"Drug: Non-immunogenic staphylokinasenon-immunogenic staphylokinase 15 mg as a single intravenous bolus Other Names: Fortelyzin®",[15],{"type":16,"name":17,"description":18,"armGroupLabels":19,"otherNames":20},"DRUG","Non-immunogenic staphylokinasenon-immunogenic staphylokinase 15 mg as a single intravenous bolus Other Names: Fortelyzin®","Non-immunogenic staphylokinase 15 mg as a single intravenous bolus",[9],[21],"Fortelyzin®",[23],{"name":24,"affiliation":25,"role":26},"Sergei S. Markin, MD, Prof.","LLC \"SuperGene\"","STUDY_DIRECTOR",[28],{"name":24,"role":29,"phone":30,"phoneExt":31,"email":32},"CONTACT","(495) 287-98-07","+7","ssmarkin2153@mail.ru",[34],{"facility":35,"status":36,"city":37,"state":10,"zip":38,"country":39,"countryCode":40,"cosmosGeoPoint":41,"geoPoint":46,"contacts":47},"E.I. Chazov National Medical Research Center of Cardiology","RECRUITING","Moscow","121552","Russia","RU",{"type":42,"coordinates":43},"Point",[44,45],37.61781,55.75204,{"lat":45,"lon":44},[48,52],{"name":49,"role":29,"phone":50,"phoneExt":31,"email":51},"Sergey N. Tereschenko, MD, Prof","(495) 150-44-19","stereschenko@yandex.ru",{"name":49,"role":53,"phone":10,"phoneExt":10,"email":10},"PRINCIPAL_INVESTIGATOR",{"type":55,"investigatorFullName":10,"investigatorTitle":10,"investigatorAffiliation":10,"oldNameTitle":10,"oldOrganization":10},"SPONSOR",[57],{"name":58,"class":59},"National Medical Research Center for Cardiology, Ministry of Health of Russian Federation","OTHER_GOV","100611849","post-registration-trial-of-the-non-immunogenic-staphylokinase-in-massive-pulmonary-embolism-100611849",false,"NCT07245927","Post-registration Trial of the Non-immunogenic Staphylokinase in Massive Pulmonary Embolism","An Open, Prospective, Non-interventional, Multicentre, Controlled Study of Safety and Efficacy of the Thrombolysis With the Non-immunogenic Staphylokinase in Patients With Massive Pulmonary Embolism (FORPE Registry)","Inclusion Criteria:\n\n* Men and women aged 18 years and older.\n* Verified diagnosis of massive pulmonary embolism (using computer tomography)\n* Signs of overload \u002F dysfunction of the right ventricle (at least one) in combination with persistent arterial hypotension or shock\n* The time from the symptoms onset is no more than 14 days.\n* Thrombolysis with the non-immunogenic staphylokinase, 15 mg as a single intravenous bolus.\n\nExclusion Criteria:\n\n* Increased risk of bleeding:\n\n  * extensive bleeding at present or within the previous 6 months;\n  * intracranial (including subarachnoid) hemorrhage at present or in history;\n  * hemorrhagic stroke within the last 6 months;\n  * a history of diseases of the central nervous system (including neoplasms, aneurysms);\n  * intracranial or spinal surgical interventions within the last 2 months;\n  * major surgery or major trauma within the previous 4 weeks;\n  * recent puncture of an incompressible 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 3 months;\n  * neoplasm with an increased risk of bleeding;\n  * simultaneous administration of Dabigatran without prior administration of idarucizumab;\n  * arterial aneurysms, developmental defects of arteries \u002F veins;\n  * acute pancreatitis;\n  * bacterial endocarditis, pericarditis;\n  * suspicion of aortic dissecting aneurysm;\n  * any other conditions, in the opinion of the investigator, associated with a high risk of bleeding.\n* Lactation, pregnancy.\n* Known hypersensitivity to the non-immunogenic recombinant staphylokinase.","ALL","18 Years",{"count":70,"type":71},20000,"ESTIMATED","OBSERVATIONAL","The aim of FORPE Registry is to study the safety and efficacy of the non-immunogenic staphylokinase in patients with massive pulmonary embolism in routine clinical practice.",[75],"Pulmonary Embolism Acute Massive",[77],"Pulmonary Embolism","2025-11-17",{"date":80,"type":81},"2025-11-24","ACTUAL",{"date":83,"type":81},"2025-06-01",{"date":85,"type":71},"2027-12-31",{"name":5,"class":6},1]