[{"data":1,"prerenderedAt":-1},["ShallowReactive",2],{"health-study-detail:100611849":3},{"organization":4,"armGroups":7,"interventions":14,"overallOfficials":22,"centralContacts":31,"locations":37,"responsibleParty":186,"collaborators":188,"id":192,"slug":193,"hasResults":194,"nctId":195,"briefTitle":196,"officialTitle":197,"acronym":10,"eligibilityCriteria":198,"healthyVolunteers":194,"sex":199,"minAge":200,"maxAge":10,"enrollmentInfo":201,"targetDuration":10,"studyType":204,"phases":10,"briefSummary":205,"conditions":206,"keywords":208,"overallStatus":40,"whyStopped":10,"lastUpdateSubmitDate":210,"lastUpdatePostDateStruct":211,"startDateStruct":214,"completionDateStruct":216,"leadSponsor":218,"locationsCount":219},{"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®",[23,27],{"name":24,"affiliation":25,"role":26},"Sergey N. 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Yudin City Clinical Hospital",{"type":45,"coordinates":126},[91,92],{"lat":92,"lon":91},[129],{"name":130,"role":33,"phone":10,"phoneExt":10,"email":10},"Natalya V. Yasnopolskaya, MD, PhD",{"facility":132,"status":40,"city":133,"state":10,"zip":10,"country":42,"countryCode":43,"cosmosGeoPoint":134,"geoPoint":138,"contacts":139},"N.A. Semashko Nizhny Novgorod Regional Clinical Hospital","Nizhny Novgorod",{"type":45,"coordinates":135},[136,137],44.00205,56.32867,{"lat":137,"lon":136},[140],{"name":141,"role":33,"phone":10,"phoneExt":10,"email":10},"Galina V. Kovaleva",{"facility":143,"status":40,"city":144,"state":10,"zip":10,"country":42,"countryCode":43,"cosmosGeoPoint":145,"geoPoint":149,"contacts":150},"G.A. Zakharyin Clinical hospital №6","Penza",{"type":45,"coordinates":146},[147,148],45.01075,53.19568,{"lat":148,"lon":147},[151],{"name":152,"role":33,"phone":10,"phoneExt":10,"email":10},"Mikhail V. Timofeev, MD, PhD",{"facility":154,"status":40,"city":155,"state":10,"zip":10,"country":42,"countryCode":43,"cosmosGeoPoint":156,"geoPoint":160,"contacts":161},"V.P. Polyakov Samara Regional Clinical Cardiology Dispensary","Samara",{"type":45,"coordinates":157},[158,159],50.13553,53.20767,{"lat":159,"lon":158},[162],{"name":163,"role":33,"phone":10,"phoneExt":10,"email":10},"Dmitry V. Duplyakov, MD, prof",{"facility":165,"status":40,"city":166,"state":10,"zip":10,"country":42,"countryCode":43,"cosmosGeoPoint":167,"geoPoint":171,"contacts":172},"Tver Regional Clinical Hospital","Tver'",{"type":45,"coordinates":168},[169,170],35.90057,56.85836,{"lat":170,"lon":169},[173],{"name":174,"role":33,"phone":10,"phoneExt":10,"email":10},"Robert M. Rabinovich, MD, PhD",{"facility":176,"status":40,"city":177,"state":10,"zip":10,"country":42,"countryCode":43,"cosmosGeoPoint":178,"geoPoint":182,"contacts":183},"City Clinical Hospital of Emergency medicine №25","Volgograd",{"type":45,"coordinates":179},[180,181],44.4976,48.71378,{"lat":181,"lon":180},[184],{"name":185,"role":33,"phone":10,"phoneExt":10,"email":10},"Eduard A. Ponomarev, MD, prof",{"type":187,"investigatorFullName":10,"investigatorTitle":10,"investigatorAffiliation":10,"oldNameTitle":10,"oldOrganization":10},"SPONSOR",[189],{"name":190,"class":191},"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":202,"type":203},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.",[207],"Pulmonary Embolism Acute Massive",[209],"Pulmonary Embolism","2026-07-01",{"date":212,"type":213},"2026-07-06","ACTUAL",{"date":215,"type":213},"2025-06-01",{"date":217,"type":203},"2027-12-31",{"name":5,"class":6},14]