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

Launched by RYAZAN STATE MEDICAL UNIVERSITY · Jun 27, 2023

Keywords

ClinConnect Summary

This clinical trial is investigating how certain markers in the blood relate to the condition known as Peripheral Arterial Occlusive Disease (PAOD), which affects blood flow to the legs. The study aims to understand the safety and effectiveness of a drug called Slavinorm® in patients who are undergoing surgery to improve blood flow in their legs. Researchers will look at various factors that indicate how well the lining of blood vessels is functioning during this process.

To participate in this study, you need to be at least 18 years old and have been diagnosed with lower extremity atherosclerotic disease, confirmed by tests like ultrasound or angiography. However, individuals with certain health issues, such as severe heart or kidney problems, or those who have had specific surgeries on their leg arteries in the past, may not qualify. If you join the trial, you can expect regular check-ups and assessments related to your condition and treatment. It's also important to know that the trial is currently recruiting participants, so there is an opportunity to get involved if you meet the eligibility criteria.

Gender

ALL

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.