[{"data":1,"prerenderedAt":-1},["ShallowReactive",2],{"health-study-detail:100467895":3},{"organization":4,"armGroups":7,"interventions":19,"overallOfficials":33,"centralContacts":41,"locations":47,"responsibleParty":170,"collaborators":32,"id":172,"slug":32,"hasResults":173,"nctId":174,"briefTitle":175,"officialTitle":176,"acronym":177,"eligibilityCriteria":178,"healthyVolunteers":173,"sex":179,"minAge":180,"maxAge":32,"enrollmentInfo":181,"targetDuration":32,"studyType":184,"phases":185,"briefSummary":187,"conditions":188,"keywords":190,"overallStatus":50,"whyStopped":32,"lastUpdateSubmitDate":194,"lastUpdatePostDateStruct":195,"startDateStruct":198,"completionDateStruct":200,"leadSponsor":202,"locationsCount":203},{"fullName":5,"class":6},"Supergene, LLC","INDUSTRY",[8,14],{"label":9,"type":10,"description":11,"interventionNames":12},"Recombinant non-immunogenic staphylokinase","EXPERIMENTAL","lyophilisate for preparation a solution, 5 mg (745,000 IU) in 20 ml over 1 minute through a perforated multihole catheter intrathrombally.\n\n30 minutes after this injection, infusion of recombinant non-immunogenic staphylokinase will be continued at a dose of 1 mg\u002Fhour, maximum 10 mg (50 ml) for 10 hours through a perforated multihole catheter intrathrombally.",[13],"Drug: Recombinant non-immunogenic staphylokinase (Fortelyzin®)",{"label":15,"type":10,"description":16,"interventionNames":17},"Surgical methods of treatment","endovascular intervention, open surgery and\u002For bypass surgery in accordance with the current National Guidelines",[18],"Procedure: surgical methods of treatment",[20,27],{"type":21,"name":22,"description":23,"armGroupLabels":24,"otherNames":25},"DRUG","Recombinant non-immunogenic staphylokinase (Fortelyzin®)","lyophilisate for preparation a solution",[9],[26],"Fortelyzin®",{"type":28,"name":29,"description":30,"armGroupLabels":31,"otherNames":32},"PROCEDURE","surgical methods of treatment","Endovascular intervention, open surgery and\u002For bypass surgery in accordance with the current National Guidelines",[15],null,[34,38],{"name":35,"affiliation":36,"role":37},"Igor I. Zatevakhin, MD, PhD","N.I. Pirogov Russian Medical University, President of the Russian Society of Surgeons","PRINCIPAL_INVESTIGATOR",{"name":39,"affiliation":5,"role":40},"Sergey S. Markin, MD, PhD","STUDY_DIRECTOR",[42],{"name":39,"role":43,"phone":44,"phoneExt":45,"email":46},"CONTACT","(906) 796-89-06","+7","amsemenof@gmail.com",[48,67,82,97,115,128,140,155],{"facility":49,"status":50,"city":51,"state":52,"zip":53,"country":54,"cosmosGeoPoint":55,"geoPoint":60,"contacts":61},"Kursk city emergency hospital","RECRUITING","Kursk","Kursl Region","305035","Russia",{"type":56,"coordinates":57},"Point",[58,59],36.18457,51.72689,{"lat":59,"lon":58},[62,66],{"name":63,"role":43,"phone":64,"phoneExt":45,"email":65},"Nikolai V. Bolomatov, MD, PhD","(471) 252-98-42","n-v-bolomatov@yandex.ru",{"name":63,"role":37,"phone":32,"phoneExt":32,"email":32},{"facility":68,"status":50,"city":69,"state":70,"zip":71,"country":54,"cosmosGeoPoint":72,"geoPoint":76,"contacts":77},"Sergiyev Posad Regional Clinical Hospital","Sergiyev Posad","Moscow Oblast","141301",{"type":56,"coordinates":73},[74,75],38.13869,56.31204,{"lat":75,"lon":74},[78,81],{"name":79,"role":43,"phone":80,"phoneExt":45,"email":32},"Anton G. Koledinskyi, MD, PhD","(49654) 2-22-84",{"name":79,"role":37,"phone":32,"phoneExt":32,"email":32},{"facility":83,"status":50,"city":84,"state":32,"zip":85,"country":54,"cosmosGeoPoint":86,"geoPoint":90,"contacts":91},"Kaliningrad Regional Clinical Hospital","Kaliningrad","236016",{"type":56,"coordinates":87},[88,89],20.51102,54.70639,{"lat":89,"lon":88},[92,96],{"name":93,"role":43,"phone":94,"phoneExt":45,"email":95},"Alexey V. Shatravka, MD, PhD","(401) 257-84-51","shatravkaa@mail.ru",{"name":93,"role":37,"phone":32,"phoneExt":32,"email":32},{"facility":98,"status":50,"city":99,"state":32,"zip":100,"country":54,"cosmosGeoPoint":101,"geoPoint":105,"contacts":106},"Kazan City Hospital No. 7","Kazan'","420103",{"type":56,"coordinates":102},[103,104],49.12214,55.78874,{"lat":104,"lon":103},[107,111,113],{"name":108,"role":43,"phone":109,"phoneExt":45,"email":110},"Ildar G. Khalilov, PhD","(843) 557-31-14.","ilhalil@mail.ru",{"name":108,"role":112,"phone":32,"phoneExt":32,"email":32},"SUB_INVESTIGATOR",{"name":114,"role":37,"phone":32,"phoneExt":32,"email":32},"Ivan V. Klushkin, PhD",{"facility":116,"status":50,"city":117,"state":32,"zip":118,"country":54,"cosmosGeoPoint":119,"geoPoint":123,"contacts":124},"S.S. Yudin City clinical hospital","Moscow","115446",{"type":56,"coordinates":120},[121,122],37.61781,55.75204,{"lat":122,"lon":121},[125,127],{"name":126,"role":43,"phone":32,"phoneExt":32,"email":32},"Bogdan B. Orlov, PhD",{"name":126,"role":37,"phone":32,"phoneExt":32,"email":32},{"facility":129,"status":50,"city":117,"state":32,"zip":130,"country":54,"cosmosGeoPoint":131,"geoPoint":133,"contacts":134},"S.P. Botkin Moscow Multidisciplinary Scientific and Clinical Center","125284",{"type":56,"coordinates":132},[121,122],{"lat":122,"lon":121},[135,139],{"name":136,"role":43,"phone":137,"phoneExt":45,"email":138},"Yuriy V. Karabach, PhD","(499) 490-03-03","yu.karabach@ya.ru",{"name":136,"role":37,"phone":32,"phoneExt":32,"email":32},{"facility":141,"status":50,"city":142,"state":32,"zip":143,"country":54,"cosmosGeoPoint":144,"geoPoint":148,"contacts":149},"Ufa Emergency City Hospital","Ufa","450092",{"type":56,"coordinates":145},[146,147],55.96779,54.74306,{"lat":147,"lon":146},[150,154],{"name":151,"role":43,"phone":152,"phoneExt":45,"email":153},"Marat S. Kashaev, PhD","(347) 291-29-96","mkashaev@gmail.com",{"name":151,"role":37,"phone":32,"phoneExt":32,"email":32},{"facility":156,"status":50,"city":157,"state":32,"zip":158,"country":54,"cosmosGeoPoint":159,"geoPoint":163,"contacts":164},"Volgograd City Clinical Hospital of Emergency #25","Volgograd","400138",{"type":56,"coordinates":160},[161,162],44.4976,48.71378,{"lat":162,"lon":161},[165,169],{"name":166,"role":43,"phone":167,"phoneExt":45,"email":168},"Eduard A. Ponomarev, MD, PhD","8442585426","ponomarev67@mail.ru",{"name":166,"role":37,"phone":32,"phoneExt":32,"email":32},{"type":171,"investigatorFullName":32,"investigatorTitle":32,"investigatorAffiliation":32,"oldNameTitle":32,"oldOrganization":32},"SPONSOR","100467895",false,"NCT05372718","Thrombolysis With Recombinant Non-immunogenic Staphylokinase vs Surgery in Patients With Acute Limb Ischemia FORAT Trial","Multicenter, Open-label, Randomized Clinical Trial of Efficacy and Safety of the Thrombolysis With Recombinant Non-immunogenic Staphylokinase (Fortelyzin®) in Patients With ALI vs Surgery","FORAT","Inclusion Criteria:\n\n* Men and women aged 18 and older;\n* Diagnosis of I-II b degree of ALI;\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* Extensive bleeding at present;\n* Intracranial (including subarachnoid) hemorrhage at present;\n* Recent gastrointestinal bleeding (within 10 days);\n* Major surgery or major trauma within the previous 3 months, recent traumatic brain injury;\n* Systolic blood pressure above 180 mm Hg or diastolic blood pressure above 110 mm Hg or the need for intravenous drugs to lower blood pressure to these limits;\n* Pregnancy, lactation;\n* Known hypersensitivity to Fortelyzin®;\n* Platelet count less than 100,000\u002FµL","ALL","18 Years",{"count":182,"type":183},170,"ESTIMATED","INTERVENTIONAL",[186],"PHASE3","Objective: to evaluate the efficacy and safety of intra-arterial intrathrombus administration of the recombinant non-immunogenic staphylokinase (Fortelyzin®) in patients with acute limb ischemia (ALI) vs surgery.",[189],"Acute Limb Ischemia",[191,192,193],"acute limb ischemia","thrombolysis","thrombosis","2025-11-27",{"date":196,"type":197},"2025-12-01","ACTUAL",{"date":199,"type":197},"2022-12-26",{"date":201,"type":183},"2026-12-31",{"name":5,"class":6},8]