[{"data":1,"prerenderedAt":-1},["ShallowReactive",2],{"health-studies-list:{\"overallStatus\":[\"RECRUITING\",\"AVAILABLE\",\"NOT_YET_RECRUITING\"],\"leadSponsorName\":\"Supergene, LLC\",\"orderBy\":\"LastUpdateSubmitDate:desc\",\"size\":25,\"offset\":0}":3,"health-study-condition:":118},{"pageToken":4,"total":5,"offset":6,"count":5,"results":7},null,4,0,[8,43,69,95],{"id":9,"slug":10,"hasResults":11,"nctId":12,"briefTitle":13,"officialTitle":14,"acronym":15,"eligibilityCriteria":16,"healthyVolunteers":11,"sex":17,"minAge":18,"maxAge":4,"enrollmentInfo":19,"targetDuration":4,"studyType":22,"phases":23,"briefSummary":25,"conditions":26,"keywords":28,"overallStatus":30,"whyStopped":4,"lastUpdateSubmitDate":31,"lastUpdatePostDateStruct":32,"startDateStruct":35,"completionDateStruct":37,"leadSponsor":39,"locationsCount":42},"100617916","phase-3-single-bolus-non-immunogenic-staphylokinase-in-patients-with-acute-ischemic-stroke-within-45-24-hours-of-symptom-onset-100617916",false,"NCT07324837","Single Bolus Non-immunogenic Staphylokinase in Patients With Acute Ischemic Stroke Within 4.5-24 Hours of Symptom Onset","A Multicenter, Double-blind, Randomized, Placebo-controlled Study of the Efficacy and Safety of the Recombinant Non-immunogenic Staphylokinase in Patients With Acute Ischemic Stroke Within 4.5-24 Hours of Symptom Onset (FRIDA-CT)","FRIDA-CT","Inclusion Criteria:\n\n1. Men and women aged 18 years and over;\n2. Acute ischemic stroke symptom onset between 4.5 to 24 hours prior to enrolment, including wake-up stroke and unwitnessed stroke, onset time refers to \"last-seen normal time\";\n3. Pre-stroke modified Rankin scale (mRS) score≤1;\n4. Internal carotid artery, middle cerebral artery M1 or M2 occlusion confirmed by CT\u002FMRI, internal carotid artery, middle cerebral artery M1 or M2 being responsible for signs and symptoms of acute ischemic stroke;\n5. Neuroimaging: target mismatch profile on CT or MRI perfusion: ischemic core volume \\\u003C70 mL, mismatch ratio≥1.8 and mismatch volume≥15 mL;\n6. Alberta Stroke Program Early CT score (ASPECTS) \\> 6;\n7. Baseline National Institutes of Health Stroke Scale (NIHSS) 6-25 (inclusive);\n8. The patient is not planned or cannot undergo thrombectomy or intravenous thrombolysis in accordance with the current version of the Clinical Guidelines;\n9. Written informed consent from patients or their legally authorized representatives.\n\nExclusion Criteria:\n\n1. Acute ischemic stroke within 4,5 h after symptom onset;\n2. Intended to proceed to endovascular treatment;\n3. Known hypersensitivity to the non-immunogenic staphylokinase;\n4. Convulsive seizures at the onset of the disease, if there is no certainty that the seizure is a clinical manifestation of acute ischemic stroke;\n5. Persistent blood pressure elevation (systolic ≥185 mmHg or diastolic ≥110 mmHg), and the inability to reduce systolic blood pressure below 180 mmHg or diastolic blood pressure below 105 mmHg;\n6. Blood glucose \\\u003C2.8 or \\>22.2 mmol\u002FL (after blood glucose level correction to the specified values, inclusion of the patient in the study is possible);\n7. Neuroimaging (CT, MRI) signs of intracranial hemorrhage, brain tumor, arteriovenous malformation, brain abscess, cerebral aneurysm;\n8. Subarachnoid hemorrhage;\n9. Major bleeding currently or within the past 6 months;\n10. Surgery on the brain or spinal cord in the last 2 months;\n11. Punctures of non-compressible arteries and veins in the last 7 days;\n12. Gastrointestinal or genitourinary bleeding in the last 3 weeks. Confirmed exacerbations of gastric ulcer and duodenal ulcer in the last 3 months;\n13. Platelet count below 100,000\u002Fmm3;\n14. Previous stroke or severe traumatic brain injury within 3 months;\n15. Unable to perform CT or MRI;\n16. History of hemorrhagic stroke or stroke of unspecified genesis;\n17. Multiple arterial occlusion (bilateral MCA occlusion, MCA occlusion accompanied with basilar occlusion);\n18. Concomitant use of indirect oral anticoagulants (warfarin) with INR \\> 1.7;\n19. Taking direct anticoagulants (heparin, heparinoids) in the previous 48 hours with an APTT value above normal;\n20. Taking new oral anticoagulants in the previous 48 hours with a thrombin time value above normal and the impossibility of administering the specific antagonist idarucizumab (for dabigatran) or the presence of anti-Xa activity (for rivaroxaban, apixaban and edoxaban).\n21. Severe liver disease, including liver failure, liver cirrhosis, portal hypertension (with esophageal varices), active hepatitis;\n22. Acute pancreatitis;\n23. Bacterial endocarditis, pericarditis;\n24. Arterial aneurysms, malformations of arteries and veins. Suspected dissecting aortic aneurysm;\n25. Cancer with an increased risk of bleeding;\n26. Major surgeries or severe injuries within the last 14 days, minor surgeries or invasive procedures within the last 10 days;\n27. Prolonged or traumatic cardiopulmonary resuscitation (more than 2 minutes);\n28. Hemorrhagic diathesis, including renal and hepatic failure;\n29. Data on bleeding or acute trauma (fracture) at the time of examination;\n30. Pregnant women, nursing mothers, or reluctant to use effective contraceptive measures during the period of trial.","ALL","18 Years",{"count":20,"type":21},990,"ESTIMATED","INTERVENTIONAL",[24],"PHASE3","Multicenter, double-blind, randomized, placebo-controlled phase III clinical trial. At the clinical sites, patients with acute ischemic stroke within 4.5-24 hours of symptom onset will be randomized to receive a single bolus injection of the recombinant non-immunogenic staphylokinase (Fortelyzin®, LLC \"SuperGene\", Russia) or placebo.",[27],"Ischemic Stroke, Acute",[29],"Ischemic Stroke","RECRUITING","2026-06-10",{"date":33,"type":34},"2026-06-12","ACTUAL",{"date":36,"type":34},"2026-06-09",{"date":38,"type":21},"2029-01-01",{"name":40,"class":41},"Supergene, LLC","INDUSTRY",15,{"id":44,"slug":45,"hasResults":11,"nctId":46,"briefTitle":47,"officialTitle":48,"acronym":4,"eligibilityCriteria":49,"healthyVolunteers":11,"sex":17,"minAge":18,"maxAge":4,"enrollmentInfo":50,"targetDuration":4,"studyType":22,"phases":52,"briefSummary":53,"conditions":54,"keywords":56,"overallStatus":30,"whyStopped":4,"lastUpdateSubmitDate":60,"lastUpdatePostDateStruct":61,"startDateStruct":63,"completionDateStruct":65,"leadSponsor":67,"locationsCount":68},"100543966","phase-3-non-immunogenic-recombinant-staphylokinase-vs-placebo-in-patients-with-intermediate-high-risk-pulmonary-embolism-100543966","NCT06362746","Non-immunogenic Recombinant Staphylokinase vs Placebo in Patients With Intermediate High-risk Pulmonary Embolism","Multicenter, Double-blind, Randomized, Placebo-controlled Trial of the Efficacy and Safety of a Single Bolus Administration of Non-immunogenic Recombinant Staphylokinase in Patients With Intermediate High-risk Pulmonary Embolism (FORPE-2)","Inclusion Criteria:\n\n* Men and women aged 18 and over.\n* Verified diagnosis of intermediate high-risk PE using CTPA, no more than two weeks from the symptoms onset.\n* RV dysfunction, defined as a RV\u002FLV ventricular end-diastolic diameter ratio more than 1.0 assessed by CTPA.\n* Increased risk of early death or hemodynamic collapse, defined by one of the following criteria:\n\n  1. systolic blood pressure less than 110 mm Hg, but not less than 90 mm Hg for more than 15 minutes;\n  2. respiratory rate more than 20 per minute or SpO2 less than 90% without oxygen support;\n  3. chronic heart failure with left ventricular ejection fraction less than 40%.\n* Serum troponin I level more than 14 pg\u002FmL in patients under 75 years, and more than 45 pg\u002FmL in patients aged 75 years or older.\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* High-risk PE with hemodynamic instability.\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.",{"count":51,"type":21},486,[24],"Objective: to evaluate the efficacy and safety of the non-immunogenic recombinant staphylokinase with its single bolus administration in comparison with placebo in normotensive patients with intermediate high-risk pulmonary embolism (PE)",[55],"Pulmonary Embolism",[57,58,59],"Intermediate high-risk pulmonary embolism","Fibrinolysis","Recombinant Non-immunogenic Staphylokinase","2025-11-27",{"date":62,"type":34},"2025-12-05",{"date":64,"type":34},"2024-05-23",{"date":66,"type":21},"2028-12-01",{"name":40,"class":41},24,{"id":70,"slug":71,"hasResults":11,"nctId":72,"briefTitle":73,"officialTitle":74,"acronym":75,"eligibilityCriteria":76,"healthyVolunteers":11,"sex":17,"minAge":18,"maxAge":4,"enrollmentInfo":77,"targetDuration":4,"studyType":22,"phases":79,"briefSummary":80,"conditions":81,"keywords":83,"overallStatus":30,"whyStopped":4,"lastUpdateSubmitDate":60,"lastUpdatePostDateStruct":87,"startDateStruct":89,"completionDateStruct":91,"leadSponsor":93,"locationsCount":94},"100467895","phase-3-thrombolysis-with-recombinant-non-immunogenic-staphylokinase-vs-surgery-in-patients-with-acute-limb-ischemia-forat-trial-100467895","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",{"count":78,"type":21},170,[24],"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.",[82],"Acute Limb Ischemia",[84,85,86],"acute limb ischemia","thrombolysis","thrombosis",{"date":88,"type":34},"2025-12-01",{"date":90,"type":34},"2022-12-26",{"date":92,"type":21},"2026-12-31",{"name":40,"class":41},8,{"id":96,"slug":97,"hasResults":11,"nctId":98,"briefTitle":99,"officialTitle":100,"acronym":4,"eligibilityCriteria":101,"healthyVolunteers":11,"sex":17,"minAge":18,"maxAge":4,"enrollmentInfo":102,"targetDuration":4,"studyType":104,"phases":4,"briefSummary":105,"conditions":106,"keywords":108,"overallStatus":30,"whyStopped":4,"lastUpdateSubmitDate":109,"lastUpdatePostDateStruct":110,"startDateStruct":112,"completionDateStruct":114,"leadSponsor":116,"locationsCount":117},"100611849","post-registration-trial-of-the-non-immunogenic-staphylokinase-in-massive-pulmonary-embolism-100611849","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.",{"count":103,"type":21},20000,"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.",[107],"Pulmonary Embolism Acute Massive",[55],"2025-11-17",{"date":111,"type":34},"2025-11-24",{"date":113,"type":34},"2025-06-01",{"date":115,"type":21},"2027-12-31",{"name":40,"class":41},1,""]