Efficacy and Safety of the Regulatory Polypeptides in Patients With Peripheral Atherosclerosis. (NCT05933720) | Clinical Trial Compass
RecruitingNot Applicable
Efficacy and Safety of the Regulatory Polypeptides in Patients With Peripheral Atherosclerosis.
Russia120 participantsStarted 2023-04-01
Plain-language 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.
Who can participate
Age range18 Years ā 80 Years
SexALL
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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 SlavinormĀ®, 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 patā¦