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Efficacy and Safety of the Regulatory Polypeptides in Patients With Peripheral Atherosclerosis.

Primary Purpose

Peripheral Arterial Occlusive Disease

Status
Recruiting
Phase
Not Applicable
Locations
Russian Federation
Study Type
Interventional
Intervention
Polypeptides
Femoral-popliteal bypass grafting with a synthetic graft above the knee
Routine conservative treatment
Sponsored by
Ryazan State Medical University
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional treatment trial for Peripheral Arterial Occlusive Disease focused on measuring Peripheral Arterial Disease, bypass grafting, polypeptides

Eligibility Criteria

18 Years - 80 Years (Adult, Older Adult)All SexesDoes not accept healthy volunteers

Inclusion Criteria: men or women over 18 years of age with lower extremity atherosclerotic arterial occlusive disease, confirmed with instrumental work-up methods (ultrasonography or angiography). Exclusion Criteria: men 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.

Sites / Locations

  • RyazanSMURecruiting

Arms of the Study

Arm 1

Arm 2

Arm 3

Arm 4

Arm Type

Active Comparator

Experimental

Active Comparator

Experimental

Arm Label

Patients who undergo routine conservative treatment

Patients who undergo treatment with polypeptides

Patients who undergo femoral-popliteal bypass with a synthetic graft above the knee

Patients who undergo femoral-popliteal bypass grafting and treatment with polypeptides

Arm Description

The patients who undergo routine conservative treatment for peripheral atherosclerotic occlusive disease as per clinical guidelines

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.

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

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.

Outcomes

Primary Outcome Measures

Lower artery or bypass graft thrombosis
The rate of the Lower artery or bypass graft thrombosis
disease progression
The rate of the disease progression
restenosis
Restenosis rate

Secondary Outcome Measures

limb loss
Limb loss rate
changes in pain-free walking distance
Changes in the parameter of pain-free walking distance (in meters)
changes in ankle-brachial index
Changes in the parameter of ankle-brachial index measured at rest

Full Information

First Posted
June 27, 2023
Last Updated
June 27, 2023
Sponsor
Ryazan State Medical University
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1. Study Identification

Unique Protocol Identification Number
NCT05933720
Brief Title
Efficacy and Safety of the Regulatory Polypeptides in Patients With Peripheral Atherosclerosis.
Official Title
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.
Study Type
Interventional

2. Study Status

Record Verification Date
June 2023
Overall Recruitment Status
Recruiting
Study Start Date
April 1, 2023 (Actual)
Primary Completion Date
June 1, 2026 (Anticipated)
Study Completion Date
September 1, 2026 (Anticipated)

3. Sponsor/Collaborators

Responsible Party, by Official Title
Principal Investigator
Name of the Sponsor
Ryazan State Medical University

4. Oversight

Studies a U.S. FDA-regulated Drug Product
No
Studies a U.S. FDA-regulated Device Product
No
Data Monitoring Committee
Yes

5. Study Description

Brief Summary
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.
Detailed Description
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).

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Peripheral Arterial Occlusive Disease
Keywords
Peripheral Arterial Disease, bypass grafting, polypeptides

7. Study Design

Primary Purpose
Treatment
Study Phase
Not Applicable
Interventional Study Model
Parallel Assignment
Model Description
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.
Masking
None (Open Label)
Allocation
Non-Randomized
Enrollment
120 (Anticipated)

8. Arms, Groups, and Interventions

Arm Title
Patients who undergo routine conservative treatment
Arm Type
Active Comparator
Arm Description
The patients who undergo routine conservative treatment for peripheral atherosclerotic occlusive disease as per clinical guidelines
Arm Title
Patients who undergo treatment with polypeptides
Arm Type
Experimental
Arm 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.
Arm Title
Patients who undergo femoral-popliteal bypass with a synthetic graft above the knee
Arm Type
Active Comparator
Arm 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
Arm Title
Patients who undergo femoral-popliteal bypass grafting and treatment with polypeptides
Arm Type
Experimental
Arm 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.
Intervention Type
Drug
Intervention Name(s)
Polypeptides
Other Intervention Name(s)
vascular polypeptides Slavinorm®, a derivative from cattle vessels
Intervention 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.
Intervention Type
Device
Intervention Name(s)
Femoral-popliteal bypass grafting with a synthetic graft above the knee
Intervention Description
The patients with undergo an arterial revascularization - Femoral-popliteal bypass grafting with a synthetic graft above the knee
Intervention Type
Other
Intervention Name(s)
Routine conservative treatment
Intervention Description
The patients will undergo routine conservative treatment as per clinical guidelines (acetylsalicylic acid 100mg daily, atorvastatin 20mg daily)
Primary Outcome Measure Information:
Title
Lower artery or bypass graft thrombosis
Description
The rate of the Lower artery or bypass graft thrombosis
Time Frame
1 year
Title
disease progression
Description
The rate of the disease progression
Time Frame
1 year
Title
restenosis
Description
Restenosis rate
Time Frame
1 year
Secondary Outcome Measure Information:
Title
limb loss
Description
Limb loss rate
Time Frame
1 year
Title
changes in pain-free walking distance
Description
Changes in the parameter of pain-free walking distance (in meters)
Time Frame
1 year
Title
changes in ankle-brachial index
Description
Changes in the parameter of ankle-brachial index measured at rest
Time Frame
1 year

10. Eligibility

Sex
All
Minimum Age & Unit of Time
18 Years
Maximum Age & Unit of Time
80 Years
Accepts Healthy Volunteers
No
Eligibility Criteria
Inclusion Criteria: men or women over 18 years of age with lower extremity atherosclerotic arterial occlusive disease, confirmed with instrumental work-up methods (ultrasonography or angiography). Exclusion Criteria: men 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.
Central Contact Person:
First Name & Middle Initial & Last Name or Official Title & Degree
Igor Aleksadrovich Suchkov
Phone
8-903-836-24-17
Email
suchkov_med@mail.ru
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Igor Suchkov
Organizational Affiliation
Ryazan State Medical University
Official's Role
Study Chair
Facility Information:
Facility Name
RyazanSMU
City
Ryazan
Country
Russian Federation
Individual Site Status
Recruiting
Facility Contact:
First Name & Middle Initial & Last Name & Degree
Igor Suchkov
Phone
+79038362417
Email
suchkov_med@mail.ru

12. IPD Sharing Statement

Learn more about this trial

Efficacy and Safety of the Regulatory Polypeptides in Patients With Peripheral Atherosclerosis.

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