Ignite Creation Date:
2025-12-25 @ 4:17 AM
Ignite Modification Date:
2025-12-26 @ 3:17 AM
Study NCT ID:
NCT05933720
Status:
RECRUITING
Last Update Posted:
2023-07-06
First Post:
2023-06-27
Is NOT Gene Therapy:
False
Has Adverse Events:
False
Brief Title:
Efficacy and Safety of the Regulatory Polypeptides in Patients With Peripheral Atherosclerosis.
Sponsor:
Organization:
Raw JSON
{'hasResults': False, 'derivedSection': {'miscInfoModule': {'versionHolder': '2025-12-24'}, 'conditionBrowseModule': {'meshes': [{'id': 'C564658', 'term': 'Peripheral Arterial Occlusive Disease 1'}, {'id': 'D058729', 'term': 'Peripheral Arterial Disease'}], 'ancestors': [{'id': 'D050197', 'term': 'Atherosclerosis'}, {'id': 'D001161', 'term': 'Arteriosclerosis'}, {'id': 'D001157', 'term': 'Arterial Occlusive Diseases'}, {'id': 'D014652', 'term': 'Vascular Diseases'}, {'id': 'D002318', 'term': 'Cardiovascular Diseases'}, {'id': 'D016491', 'term': 'Peripheral Vascular Diseases'}]}, 'interventionBrowseModule': {'meshes': [{'id': 'D010455', 'term': 'Peptides'}], 'ancestors': [{'id': 'D000602', 'term': 'Amino Acids, Peptides, and Proteins'}]}}, 'protocolSection': {'designModule': {'phases': ['NA'], 'studyType': 'INTERVENTIONAL', 'designInfo': {'allocation': 'NON_RANDOMIZED', 'maskingInfo': {'masking': 'NONE'}, 'primaryPurpose': 'TREATMENT', 'interventionModel': 'PARALLEL', 'interventionModelDescription': 'An open, prospective study is aimed at enrolling 120 patients with lower extremity atherosclerotic arterial occlusive disease. Patients are planned to undergo conservative therapy according to indications, including the use of a drug based on vascular polypeptides Slavinorm®, as well as a combination of conservative therapy, including a drug based on vascular polypeptides Slavinorm®, with surgical methods of treatment (femoral-popliteal bypass grafting with a synthetic graft above the knee). Subjects of similar age, gender, and ethnicity should be divided into four groups, respectively.'}, 'enrollmentInfo': {'type': 'ESTIMATED', 'count': 120}}, 'statusModule': {'overallStatus': 'RECRUITING', 'startDateStruct': {'date': '2023-04-01', 'type': 'ACTUAL'}, 'expandedAccessInfo': {'hasExpandedAccess': False}, 'statusVerifiedDate': '2023-06', 'completionDateStruct': {'date': '2026-09-01', 'type': 'ESTIMATED'}, 'lastUpdateSubmitDate': '2023-06-27', 'studyFirstSubmitDate': '2023-06-27', 'studyFirstSubmitQcDate': '2023-06-27', 'lastUpdatePostDateStruct': {'date': '2023-07-06', 'type': 'ACTUAL'}, 'studyFirstPostDateStruct': {'date': '2023-07-06', 'type': 'ACTUAL'}, 'primaryCompletionDateStruct': {'date': '2026-06-01', 'type': 'ESTIMATED'}}, 'outcomesModule': {'primaryOutcomes': [{'measure': 'Lower artery or bypass graft thrombosis', 'timeFrame': '1 year', 'description': 'The rate of the Lower artery or bypass graft thrombosis'}, {'measure': 'disease progression', 'timeFrame': '1 year', 'description': 'The rate of the disease progression'}, {'measure': 'restenosis', 'timeFrame': '1 year', 'description': 'Restenosis rate'}], 'secondaryOutcomes': [{'measure': 'limb loss', 'timeFrame': '1 year', 'description': 'Limb loss rate'}, {'measure': 'changes in pain-free walking distance', 'timeFrame': '1 year', 'description': 'Changes in the parameter of pain-free walking distance (in meters)'}, {'measure': 'changes in ankle-brachial index', 'timeFrame': '1 year', 'description': 'Changes in the parameter of ankle-brachial index measured at rest'}]}, 'oversightModule': {'oversightHasDmc': True, 'isFdaRegulatedDrug': False, 'isFdaRegulatedDevice': False}, 'conditionsModule': {'keywords': ['Peripheral Arterial Disease', 'bypass grafting', 'polypeptides'], 'conditions': ['Peripheral Arterial Occlusive Disease']}, 'descriptionModule': {'briefSummary': 'The study is aimed at assessing the role of the activity of markers of endothelial dysfunction (cytotoxic malonic aldehyde (MDA), angiotensin II, endothelial nitric oxide synthase (NO), endothelin-1, prostacyclin) in the systemic circulation in patients with lower extremity atherosclerotic arterial occlusive disease undergoing open reconstructive interventions.', 'detailedDescription': 'The study will include 120 patients of similar age, gender, and ethnicity, they will be divided into four groups: Group I: 30 patients with lower extremity atherosclerotic arterial occlusive disease, stage IIA-IIB of the disease according to the Fontaine-Pokrovsky classification, receiving conservative therapy; Group II: 30 patients with lower extremity atherosclerotic arterial occlusive disease, stage IIA-IIB of the disease according to the Fontaine-Pokrovsky classification, receiving conservative therapy, including the drug based on vascular polypeptides Slavinorm®; Group III: 30 patients with lower extremity atherosclerotic arterial occlusive disease, stageIII-IV of the disease according to the Fontaine-Pokrovsky classification, receiving conservative therapy in combination with surgical methods of treatment (femoral-popliteal bypass grafting with a synthetic graft above the knee); Group IV: 30 patients with lower extremity atherosclerotic arterial occlusive disease, stage III-IV of the disease according to the Fontaine-Pokrovsky classification, receiving conservative therapy, including the drug based on vascular polypeptides Slavinorm®, in combination with surgical methods of treatment (femoral-popliteal bypass grafting with a synthetic graft above the knee).'}, 'eligibilityModule': {'sex': 'ALL', 'stdAges': ['ADULT', 'OLDER_ADULT'], 'maximumAge': '80 Years', 'minimumAge': '18 Years', 'healthyVolunteers': False, 'eligibilityCriteria': 'Inclusion Criteria:\n\nmen or women over 18 years of age with lower extremity atherosclerotic arterial occlusive disease, confirmed with instrumental work-up methods (ultrasonography or angiography).\n\nExclusion Criteria:\n\nmen or women under 18 years of age; history of anaphylaxis; hypersensitivity to any of the components that make up the drug Slavinorm®, and proteins of animal origin; absolute and relative contraindications to the treadmill test; failure to walk at a minimum speed of 3.2 km/h (2 mph) at a minimum treadmill angle for at least 2 minutes during the stress test during the screening phase; depression of the ST segment more than 1 mm in one or more standard leads on the electrocardiogram; peripheral artery disease not associated with atherosclerosis; patients who underwent reconstructive surgery or invasive interventions on the arteries of the lower extremities in history without a clinic of intermittent claudication; angina pectoris III-IV functional class (FC) according to the CCS classification; body mass index \\>35 kg/m2; acute or chronic renal (creatinine clearance less than 30 ml / min) and / or liver failure \\[aspartate aminotransferase (AST), alanine aminotransferase (ALT) \\> 3 times the upper limit of normal\\]; chronic heart failure III-IV FC according to NYHA; acute coronary syndrome within 6 months. before the start of the screening period; any clinically significant condition or comorbidity that, in the opinion of the Investigator, would preclude the patient from participating in the study.'}, 'identificationModule': {'nctId': 'NCT05933720', 'briefTitle': 'Efficacy and Safety of the Regulatory Polypeptides in Patients With Peripheral Atherosclerosis.', 'organization': {'class': 'OTHER', 'fullName': 'Ryazan State Medical University'}, 'officialTitle': 'Evaluation of the Efficacy and Safety of the Drug Based on Vascular Regulatory Polypeptides for the Treatment of Patients With Lower Extremity Atherosclerotic Arterial Occlusive Disease.', 'orgStudyIdInfo': {'id': '10'}}, 'armsInterventionsModule': {'armGroups': [{'type': 'ACTIVE_COMPARATOR', 'label': 'Patients who undergo routine conservative treatment', 'description': 'The patients who undergo routine conservative treatment for peripheral atherosclerotic occlusive disease as per clinical guidelines', 'interventionNames': ['Other: Routine conservative treatment']}, {'type': 'EXPERIMENTAL', 'label': 'Patients who undergo treatment with polypeptides', 'description': 'The patients who undergo treatment with a complex of polypeptides isolated from the vessels of cattle is administered in / m, adults 1 vial (5 mg) 1 time / day 2 times a week. The course of treatment is 10 injections.', 'interventionNames': ['Drug: Polypeptides']}, {'type': 'ACTIVE_COMPARATOR', 'label': 'Patients who undergo femoral-popliteal bypass with a synthetic graft above the knee', 'description': 'Patients who undergo the surgical method of treatment i.e. femoral-popliteal bypass grafting with a synthetic graft above the knee and routine conservative treatment as per clinical guidelines', 'interventionNames': ['Device: Femoral-popliteal bypass grafting with a synthetic graft above the knee', 'Other: Routine conservative treatment']}, {'type': 'EXPERIMENTAL', 'label': 'Patients who undergo femoral-popliteal bypass grafting and treatment with polypeptides', 'description': 'Patients who undergo the surgical method of treatment i.e. femoral-popliteal bypass grafting with a synthetic graft above the knee with following treatment with a complex of polypeptides isolated from the vessels of cattle is administered in / m, adults 1 vial (5 mg) 1 time / day 2 times a week. The course of treatment is 10 injections.', 'interventionNames': ['Drug: Polypeptides', 'Device: Femoral-popliteal bypass grafting with a synthetic graft above the knee']}], 'interventions': [{'name': 'Polypeptides', 'type': 'DRUG', 'otherNames': ['vascular polypeptides Slavinorm®, a derivative from cattle vessels'], 'description': 'The patients will undergo treatment with a drug based on vascular polypeptides Slavinorm®, a derivative from cattle vessels, registered in Russia for the treatment of patients with peripheral atherosclerotic occlusive disease.', 'armGroupLabels': ['Patients who undergo femoral-popliteal bypass grafting and treatment with polypeptides', 'Patients who undergo treatment with polypeptides']}, {'name': 'Femoral-popliteal bypass grafting with a synthetic graft above the knee', 'type': 'DEVICE', 'description': 'The patients with undergo an arterial revascularization - Femoral-popliteal bypass grafting with a synthetic graft above the knee', 'armGroupLabels': ['Patients who undergo femoral-popliteal bypass grafting and treatment with polypeptides', 'Patients who undergo femoral-popliteal bypass with a synthetic graft above the knee']}, {'name': 'Routine conservative treatment', 'type': 'OTHER', 'description': 'The patients will undergo routine conservative treatment as per clinical guidelines (acetylsalicylic acid 100mg daily, atorvastatin 20mg daily)', 'armGroupLabels': ['Patients who undergo femoral-popliteal bypass with a synthetic graft above the knee', 'Patients who undergo routine conservative treatment']}]}, 'contactsLocationsModule': {'locations': [{'city': 'Ryazan', 'status': 'RECRUITING', 'country': 'Russia', 'contacts': [{'name': 'Igor Suchkov', 'role': 'CONTACT', 'email': 'suchkov_med@mail.ru', 'phone': '+79038362417'}], 'facility': 'RyazanSMU', 'geoPoint': {'lat': 54.62696, 'lon': 39.70415}}], 'centralContacts': [{'name': 'Igor Aleksadrovich Suchkov', 'role': 'CONTACT', 'email': 'suchkov_med@mail.ru', 'phone': '8-903-836-24-17'}], 'overallOfficials': [{'name': 'Igor Suchkov', 'role': 'STUDY_CHAIR', 'affiliation': 'Ryazan State Medical University'}]}, 'sponsorCollaboratorsModule': {'leadSponsor': {'name': 'Ryazan State Medical University', 'class': 'OTHER'}, 'responsibleParty': {'type': 'PRINCIPAL_INVESTIGATOR', 'investigatorTitle': 'Resident cardiovascular surgeon in the Department of Cardiovascular, Endovascular Surgery and Diagnostic Radiology', 'investigatorFullName': 'Lyasheva Anastasia Vladimirovna', 'investigatorAffiliation': 'Ryazan State Medical University'}}}}