[{"data":1,"prerenderedAt":-1},["ShallowReactive",2],{"health-study-detail:100467895":3},{"organization":4,"armGroups":7,"interventions":19,"overallOfficials":33,"centralContacts":41,"locations":47,"responsibleParty":171,"collaborators":32,"id":173,"slug":174,"hasResults":175,"nctId":176,"briefTitle":177,"officialTitle":178,"acronym":179,"eligibilityCriteria":180,"healthyVolunteers":175,"sex":181,"minAge":182,"maxAge":32,"enrollmentInfo":183,"targetDuration":32,"studyType":186,"phases":187,"briefSummary":189,"conditions":190,"keywords":192,"overallStatus":50,"whyStopped":32,"lastUpdateSubmitDate":196,"lastUpdatePostDateStruct":197,"startDateStruct":200,"completionDateStruct":202,"leadSponsor":204,"locationsCount":205},{"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",[48,68,83,98,116,129,141,156],{"facility":49,"status":50,"city":51,"state":52,"zip":53,"country":54,"countryCode":55,"cosmosGeoPoint":56,"geoPoint":61,"contacts":62},"Kursk city emergency hospital","RECRUITING","Kursk","Kursl Region","305035","Russia","RU",{"type":57,"coordinates":58},"Point",[59,60],36.18457,51.72689,{"lat":60,"lon":59},[63,67],{"name":64,"role":43,"phone":65,"phoneExt":45,"email":66},"Nikolai V. Bolomatov, MD, PhD","(471) 252-98-42","n-v-bolomatov@yandex.ru",{"name":64,"role":37,"phone":32,"phoneExt":32,"email":32},{"facility":69,"status":50,"city":70,"state":71,"zip":72,"country":54,"countryCode":55,"cosmosGeoPoint":73,"geoPoint":77,"contacts":78},"Sergiyev Posad Regional Clinical Hospital","Sergiyev Posad","Moscow Oblast","141301",{"type":57,"coordinates":74},[75,76],38.13869,56.31204,{"lat":76,"lon":75},[79,82],{"name":80,"role":43,"phone":81,"phoneExt":45,"email":32},"Anton G. Koledinskyi, MD, PhD","(49654) 2-22-84",{"name":80,"role":37,"phone":32,"phoneExt":32,"email":32},{"facility":84,"status":50,"city":85,"state":32,"zip":86,"country":54,"countryCode":55,"cosmosGeoPoint":87,"geoPoint":91,"contacts":92},"Kaliningrad Regional Clinical Hospital","Kaliningrad","236016",{"type":57,"coordinates":88},[89,90],20.51102,54.70639,{"lat":90,"lon":89},[93,97],{"name":94,"role":43,"phone":95,"phoneExt":45,"email":96},"Alexey V. Shatravka, MD, PhD","(401) 257-84-51","shatravkaa@mail.ru",{"name":94,"role":37,"phone":32,"phoneExt":32,"email":32},{"facility":99,"status":50,"city":100,"state":32,"zip":101,"country":54,"countryCode":55,"cosmosGeoPoint":102,"geoPoint":106,"contacts":107},"Kazan City Hospital No. 7","Kazan'","420103",{"type":57,"coordinates":103},[104,105],49.12214,55.78874,{"lat":105,"lon":104},[108,112,114],{"name":109,"role":43,"phone":110,"phoneExt":45,"email":111},"Ildar G. Khalilov, PhD","(843) 557-31-14.","ilhalil@mail.ru",{"name":109,"role":113,"phone":32,"phoneExt":32,"email":32},"SUB_INVESTIGATOR",{"name":115,"role":37,"phone":32,"phoneExt":32,"email":32},"Ivan V. Klushkin, PhD",{"facility":117,"status":50,"city":118,"state":32,"zip":119,"country":54,"countryCode":55,"cosmosGeoPoint":120,"geoPoint":124,"contacts":125},"S.S. Yudin City clinical hospital","Moscow","115446",{"type":57,"coordinates":121},[122,123],37.61781,55.75204,{"lat":123,"lon":122},[126,128],{"name":127,"role":43,"phone":32,"phoneExt":32,"email":32},"Bogdan B. Orlov, PhD",{"name":127,"role":37,"phone":32,"phoneExt":32,"email":32},{"facility":130,"status":50,"city":118,"state":32,"zip":131,"country":54,"countryCode":55,"cosmosGeoPoint":132,"geoPoint":134,"contacts":135},"S.P. Botkin Moscow Multidisciplinary Scientific and Clinical Center","125284",{"type":57,"coordinates":133},[122,123],{"lat":123,"lon":122},[136,140],{"name":137,"role":43,"phone":138,"phoneExt":45,"email":139},"Yuriy V. Karabach, PhD","(499) 490-03-03","yu.karabach@ya.ru",{"name":137,"role":37,"phone":32,"phoneExt":32,"email":32},{"facility":142,"status":50,"city":143,"state":32,"zip":144,"country":54,"countryCode":55,"cosmosGeoPoint":145,"geoPoint":149,"contacts":150},"Ufa Emergency City Hospital","Ufa","450092",{"type":57,"coordinates":146},[147,148],55.96779,54.74306,{"lat":148,"lon":147},[151,155],{"name":152,"role":43,"phone":153,"phoneExt":45,"email":154},"Marat S. Kashaev, PhD","(347) 291-29-96","mkashaev@gmail.com",{"name":152,"role":37,"phone":32,"phoneExt":32,"email":32},{"facility":157,"status":50,"city":158,"state":32,"zip":159,"country":54,"countryCode":55,"cosmosGeoPoint":160,"geoPoint":164,"contacts":165},"Volgograd City Clinical Hospital of Emergency #25","Volgograd","400138",{"type":57,"coordinates":161},[162,163],44.4976,48.71378,{"lat":163,"lon":162},[166,170],{"name":167,"role":43,"phone":168,"phoneExt":45,"email":169},"Eduard A. Ponomarev, MD, PhD","8442585426","ponomarev67@mail.ru",{"name":167,"role":37,"phone":32,"phoneExt":32,"email":32},{"type":172,"investigatorFullName":32,"investigatorTitle":32,"investigatorAffiliation":32,"oldNameTitle":32,"oldOrganization":32},"SPONSOR","100467895","phase-3-thrombolysis-with-recombinant-non-immunogenic-staphylokinase-vs-surgery-in-patients-with-acute-limb-ischemia-forat-trial-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":184,"type":185},170,"ESTIMATED","INTERVENTIONAL",[188],"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.",[191],"Acute Limb Ischemia",[193,194,195],"acute limb ischemia","thrombolysis","thrombosis","2025-11-27",{"date":198,"type":199},"2025-12-01","ACTUAL",{"date":201,"type":199},"2022-12-26",{"date":203,"type":185},"2026-12-31",{"name":5,"class":6},8]