The assessment of cysteinyl leuktriene receptor antagonist (montelukast) role in inhibition of atherosclerosis in patients undergoing endovascular treatment due to peripheral arterial disease.

Phase 1

• Conditions: Occlusive atherosclerosis in patients treated endovascularly due to ischemia of the lower limbs in the course of obstructive artery disease.; MedDRA version: 21.1Level: LLTClassification code 10067825Term: Peripheral arterial diseaseSystem Organ Class: 10047065 - Vascular disorders; Therapeutic area: Diseases [C] - Cardiovascular Diseases [C14]

• Registration Number: EUCTR2020-000715-71-PL
• Lead Sponsor: Jagiellonian University Medical College

Brief Summary

Not available

Detailed Description

Not available

Study Timeline

• Results First Posted: 1900-01-01
• Study Start: 2021-01-27
• Last Update Posted: 12 March 2024

Recruitment & Eligibility

• Status: Authorised-recruitment may be ongoing or finished
• Sex: All
• Target Recruitment: 200

Inclusion Criteria

? Patients with PAOD qualified for PTAvin the Angiology Department UJ CM, with Rutherford 3 or 4 clinical symptoms.
? Age 45 - 75 years old.
? Signed informed consent.
? Citizen of Malopolska region
Are the trial subjects under 18? no
Number of subjects for this age range:
F.1.2 Adults (18-64 years) yes
F.1.2.1 Number of subjects for this age range 100
F.1.3 Elderly (>=65 years) yes
F.1.3.1 Number of subjects for this age range 100

Exclusion Criteria

? Patients with peripheral arterial disease (PAOD) with Rutherford 1,2,5 or 6 clinical symptoms.
? Age < 45 or > 75 years old.
? Infection and/or fever (temperature above 37,2 C) within the last 3 weeks preceding the study recruitment (viral infections, cold, sinusitis) and use of antibiotics within the last 2 months.
? Symptoms of acute tissue infection
? Chronic inflammatory disease (e.g. COPD stage >II in GOLD classification)
? HIV+, HCV+, HBS+.
? Autoimmunological diseases and use of steroids or immunosuppressive medications within the last 3 months.
? Inflammatory blood vessel disorders (with exception of atherosclerosis)
? Myocardial infarction or stoke within last 6 months.
? Buerger Disease.
? Chronic heart failure (3-4 NYHA)
? Acute lower limb ischemia or surgical revascularization within last 6 months.
? Serious trauma or surgery procedure within last 6 months.
? Asthma.
? On-going antileukotriene treatment.
? Neoplasm diagnosed within 5 years.
? Chronic Kidney Disease (creat. >177 µmol/l).
? Pregnancy, puerperium, women without efficient contraception.
? Vaccinations within 30 days before recruitment.
? Hospitalisation in intensive care unit within 3 months.
? Lack of the possibility of the follow-up participation.

Study & Design

• Study Type: Interventional clinical trial of medicinal product
• Study Design: Not specified