Ignite Creation Date:
2025-12-25 @ 5:03 AM
Ignite Modification Date:
2025-12-26 @ 4:05 AM
Study NCT ID:
NCT05372718
Status:
RECRUITING
Last Update Posted:
2025-12-01
First Post:
2022-04-28
Is NOT Gene Therapy:
False
Has Adverse Events:
False
Brief Title:
Thrombolysis With Recombinant Non-immunogenic Staphylokinase vs Surgery in Patients With Acute Limb Ischemia FORAT Trial
Sponsor:
Organization:
Raw JSON
{'hasResults': False, 'derivedSection': {'miscInfoModule': {'versionHolder': '2025-12-24'}, 'conditionBrowseModule': {'meshes': [{'id': 'D013927', 'term': 'Thrombosis'}], 'ancestors': [{'id': 'D016769', 'term': 'Embolism and Thrombosis'}, {'id': 'D014652', 'term': 'Vascular Diseases'}, {'id': 'D002318', 'term': 'Cardiovascular Diseases'}]}}, 'protocolSection': {'designModule': {'phases': ['PHASE3'], 'studyType': 'INTERVENTIONAL', 'designInfo': {'allocation': 'RANDOMIZED', 'maskingInfo': {'masking': 'NONE', 'maskingDescription': 'Open-label'}, 'primaryPurpose': 'TREATMENT', 'interventionModel': 'PARALLEL', 'interventionModelDescription': 'At clinical centers, patients will be randomly distributed by the "envelope method" into two groups for assignation Fortelyzin® or surgical methods of treatment.'}, 'enrollmentInfo': {'type': 'ESTIMATED', 'count': 170}}, 'statusModule': {'overallStatus': 'RECRUITING', 'startDateStruct': {'date': '2022-12-26', 'type': 'ACTUAL'}, 'expandedAccessInfo': {'hasExpandedAccess': False}, 'statusVerifiedDate': '2025-11', 'completionDateStruct': {'date': '2026-12-31', 'type': 'ESTIMATED'}, 'lastUpdateSubmitDate': '2025-11-27', 'studyFirstSubmitDate': '2022-04-28', 'studyFirstSubmitQcDate': '2022-05-12', 'lastUpdatePostDateStruct': {'date': '2025-12-01', 'type': 'ESTIMATED'}, 'studyFirstPostDateStruct': {'date': '2022-05-13', 'type': 'ACTUAL'}, 'primaryCompletionDateStruct': {'date': '2026-12-31', 'type': 'ESTIMATED'}}, 'outcomesModule': {'otherOutcomes': [{'measure': 'Safety endpoint - Death from all causes', 'timeFrame': '30 days post randomization', 'description': 'The safety is evaluated in terms of the number of deaths from all causes'}, {'measure': 'Safety endpoint - hemorrhagic stroke', 'timeFrame': '30 days post randomization', 'description': 'The safety is evaluated in terms of the number of hemorrhagic stroke'}, {'measure': 'Safety endpoint - BARC type 3 and 5 bleeding', 'timeFrame': '30 days post randomization', 'description': 'The safety is evaluated in terms of the number of BARC type 3 and 5 bleeding'}, {'measure': 'Safety endpoint - Number and severity of serious adverse events (SAEs) and AEs in organs and systems', 'timeFrame': '30 days post randomization', 'description': 'The safety is evaluated in terms of the number and severity of SAEs and AEs in organs and systems'}], 'primaryOutcomes': [{'measure': 'Number of patients without amputations', 'timeFrame': '30 days post randomization', 'description': 'Outcome Measure is evaluated in terms of the number of patients without amputations'}]}, 'oversightModule': {'oversightHasDmc': False, 'isFdaRegulatedDrug': False, 'isFdaRegulatedDevice': False}, 'conditionsModule': {'keywords': ['acute limb ischemia', 'thrombolysis', 'thrombosis'], 'conditions': ['Acute Limb Ischemia']}, 'referencesModule': {'references': [{'pmid': '34418399', 'type': 'RESULT', 'citation': 'Gusev EI, Martynov MY, Nikonov AA, Shamalov NA, Semenov MP, Gerasimets EA, Yarovaya EB, Semenov AM, Archakov AI, Markin SS; FRIDA Study Group. Non-immunogenic recombinant staphylokinase versus alteplase for patients with acute ischaemic stroke 4.5 h after symptom onset in Russia (FRIDA): a randomised, open label, multicentre, parallel-group, non-inferiority trial. Lancet Neurol. 2021 Sep;20(9):721-728. doi: 10.1016/S1474-4422(21)00210-6.'}]}, 'descriptionModule': {'briefSummary': '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.', 'detailedDescription': 'Fortelyzin® (the active substance Forteplase) is a recombinant non-immunogenic staphylokinase with high fibrinselective thrombolytic activity. In a multicentre, randomised clinical trial in patients with ST-segment elevation myocardial infarction (FRIDOM), non-immunogenic staphylokinase was administered as a single intravenous bolus of 15 mg in all patients, regardless of bodyweight, and showed similar high reperfusion patency and fewer minor bleeding events compared with tenecteplase, as well as the absence of neutralising IgGs. Results of the multicentre, randomised clinical trial in patients with an acute ischaemic stroke (FRIDA) suggested that the non-immunogenic staphylokinase administrated as a single intravenous bolus of 10 mg in all patients within the 4-5 h after the onset of symptoms is non-inferior to alteplase. Mortality, symptomatic intracranial haemorrhage, and serious adverse events did not differ between treatment groups.\n\nMortality in the ALI continues to be high. According to the Guidelines on the management of patients with ALI, intravenous systemic thrombolysis is ineffective in patients with this condition. In contrast, catheter-directed thrombolysis based on the principle that activation of fibrin-bound plasminogen to the active enzyme plasmin is the most effective approach of lysing pathologic thrombi in the lower extremities of I-II b degree of ALI (Evidence level I-A).\n\nSo the main objective of this study is to evaluate the efficacy and safety of intra-arterial intrathrombus administration of the recombinant non-immunogenic staphylokinase (Fortelyzin®) in patients with ALI vs surgery.'}, 'eligibilityModule': {'sex': 'ALL', 'stdAges': ['ADULT', 'OLDER_ADULT'], 'minimumAge': '18 Years', 'healthyVolunteers': False, 'eligibilityCriteria': '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/µL'}, 'identificationModule': {'nctId': 'NCT05372718', 'acronym': 'FORAT', 'briefTitle': 'Thrombolysis With Recombinant Non-immunogenic Staphylokinase vs Surgery in Patients With Acute Limb Ischemia FORAT Trial', 'organization': {'class': 'INDUSTRY', 'fullName': 'Supergene, LLC'}, 'officialTitle': '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', 'orgStudyIdInfo': {'id': 'FORAT'}}, 'armsInterventionsModule': {'armGroups': [{'type': 'EXPERIMENTAL', 'label': 'Recombinant non-immunogenic staphylokinase', 'description': '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/hour, maximum 10 mg (50 ml) for 10 hours through a perforated multihole catheter intrathrombally.', 'interventionNames': ['Drug: Recombinant non-immunogenic staphylokinase (Fortelyzin®)']}, {'type': 'EXPERIMENTAL', 'label': 'Surgical methods of treatment', 'description': 'endovascular intervention, open surgery and/or bypass surgery in accordance with the current National Guidelines', 'interventionNames': ['Procedure: surgical methods of treatment']}], 'interventions': [{'name': 'Recombinant non-immunogenic staphylokinase (Fortelyzin®)', 'type': 'DRUG', 'otherNames': ['Fortelyzin®'], 'description': 'lyophilisate for preparation a solution', 'armGroupLabels': ['Recombinant non-immunogenic staphylokinase']}, {'name': 'surgical methods of treatment', 'type': 'PROCEDURE', 'description': 'Endovascular intervention, open surgery and/or bypass surgery in accordance with the current National Guidelines', 'armGroupLabels': ['Surgical methods of treatment']}]}, 'contactsLocationsModule': {'locations': [{'zip': '305035', 'city': 'Kursk', 'state': 'Kursl Region', 'status': 'RECRUITING', 'country': 'Russia', 'contacts': [{'name': 'Nikolai V. Bolomatov, MD, PhD', 'role': 'CONTACT', 'email': 'n-v-bolomatov@yandex.ru', 'phone': '(471) 252-98-42', 'phoneExt': '+7'}, {'name': 'Nikolai V. Bolomatov, MD, PhD', 'role': 'PRINCIPAL_INVESTIGATOR'}], 'facility': 'Kursk city emergency hospital', 'geoPoint': {'lat': 51.72689, 'lon': 36.18457}}, {'zip': '141301', 'city': 'Sergiyev Posad', 'state': 'Moscow Oblast', 'status': 'RECRUITING', 'country': 'Russia', 'contacts': [{'name': 'Anton G. Koledinskyi, MD, PhD', 'role': 'CONTACT', 'phone': '(49654) 2-22-84', 'phoneExt': '+7'}, {'name': 'Anton G. Koledinskyi, MD, PhD', 'role': 'PRINCIPAL_INVESTIGATOR'}], 'facility': 'Sergiyev Posad Regional Clinical Hospital', 'geoPoint': {'lat': 56.31204, 'lon': 38.13869}}, {'zip': '236016', 'city': 'Kaliningrad', 'status': 'RECRUITING', 'country': 'Russia', 'contacts': [{'name': 'Alexey V. Shatravka, MD, PhD', 'role': 'CONTACT', 'email': 'shatravkaa@mail.ru', 'phone': '(401) 257-84-51', 'phoneExt': '+7'}, {'name': 'Alexey V. Shatravka, MD, PhD', 'role': 'PRINCIPAL_INVESTIGATOR'}], 'facility': 'Kaliningrad Regional Clinical Hospital', 'geoPoint': {'lat': 54.70639, 'lon': 20.51102}}, {'zip': '420103', 'city': "Kazan'", 'status': 'RECRUITING', 'country': 'Russia', 'contacts': [{'name': 'Ildar G. Khalilov, PhD', 'role': 'CONTACT', 'email': 'ilhalil@mail.ru', 'phone': '(843) 557-31-14.', 'phoneExt': '+7'}, {'name': 'Ildar G. Khalilov, PhD', 'role': 'SUB_INVESTIGATOR'}, {'name': 'Ivan V. Klushkin, PhD', 'role': 'PRINCIPAL_INVESTIGATOR'}], 'facility': 'Kazan City Hospital No. 7', 'geoPoint': {'lat': 55.78874, 'lon': 49.12214}}, {'zip': '115446', 'city': 'Moscow', 'status': 'RECRUITING', 'country': 'Russia', 'contacts': [{'name': 'Bogdan B. Orlov, PhD', 'role': 'CONTACT'}, {'name': 'Bogdan B. Orlov, PhD', 'role': 'PRINCIPAL_INVESTIGATOR'}], 'facility': 'S.S. Yudin City clinical hospital', 'geoPoint': {'lat': 55.75204, 'lon': 37.61781}}, {'zip': '125284', 'city': 'Moscow', 'status': 'RECRUITING', 'country': 'Russia', 'contacts': [{'name': 'Yuriy V. Karabach, PhD', 'role': 'CONTACT', 'email': 'yu.karabach@ya.ru', 'phone': '(499) 490-03-03', 'phoneExt': '+7'}, {'name': 'Yuriy V. Karabach, PhD', 'role': 'PRINCIPAL_INVESTIGATOR'}], 'facility': 'S.P. Botkin Moscow Multidisciplinary Scientific and Clinical Center', 'geoPoint': {'lat': 55.75204, 'lon': 37.61781}}, {'zip': '450092', 'city': 'Ufa', 'status': 'RECRUITING', 'country': 'Russia', 'contacts': [{'name': 'Marat S. Kashaev, PhD', 'role': 'CONTACT', 'email': 'mkashaev@gmail.com', 'phone': '(347) 291-29-96', 'phoneExt': '+7'}, {'name': 'Marat S. Kashaev, PhD', 'role': 'PRINCIPAL_INVESTIGATOR'}], 'facility': 'Ufa Emergency City Hospital', 'geoPoint': {'lat': 54.74306, 'lon': 55.96779}}, {'zip': '400138', 'city': 'Volgograd', 'status': 'RECRUITING', 'country': 'Russia', 'contacts': [{'name': 'Eduard A. Ponomarev, MD, PhD', 'role': 'CONTACT', 'email': 'ponomarev67@mail.ru', 'phone': '8442585426', 'phoneExt': '+7'}, {'name': 'Eduard A. Ponomarev, MD, PhD', 'role': 'PRINCIPAL_INVESTIGATOR'}], 'facility': 'Volgograd City Clinical Hospital of Emergency #25', 'geoPoint': {'lat': 48.71378, 'lon': 44.4976}}], 'centralContacts': [{'name': 'Sergey S. Markin, MD, PhD', 'role': 'CONTACT', 'email': 'amsemenof@gmail.com', 'phone': '(906) 796-89-06', 'phoneExt': '+7'}], 'overallOfficials': [{'name': 'Igor I. Zatevakhin, MD, PhD', 'role': 'PRINCIPAL_INVESTIGATOR', 'affiliation': 'N.I. Pirogov Russian Medical University, President of the Russian Society of Surgeons'}, {'name': 'Sergey S. Markin, MD, PhD', 'role': 'STUDY_DIRECTOR', 'affiliation': 'Supergene, LLC'}]}, 'ipdSharingStatementModule': {'ipdSharing': 'NO'}, 'sponsorCollaboratorsModule': {'leadSponsor': {'name': 'Supergene, LLC', 'class': 'INDUSTRY'}, 'responsibleParty': {'type': 'SPONSOR'}}}}