Status:
UNKNOWN
Cysteinyl Leukotriene Antagonist in Atherosclerosis Inhibition in Patients After Endovascular Treatment Due to Peripheral Arterial Disease
Lead Sponsor:
Jagiellonian University
Conditions:
Peripheral Arterial Disease
Peripheral Vascular Diseases
Eligibility:
All Genders
45-75 years
Phase:
PHASE3
Brief Summary
Atherosclerosis is a civilization disease, which pathophysiology is based on chronic inflammatory response in the wall of vessels that is caused by increase of pro-inflammatory substances. It is a sig...
Eligibility Criteria
Inclusion
- Patients with peripheral arterial disease qualified for endovascular treatment with Rutherford 3 or 4 clinical symptoms.
- Age 45 - 75 years old.
- Signed informed consent.
Exclusion
- 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.
Key Trial Info
Start Date :
May 1 2020
Trial Type :
INTERVENTIONAL
Allocation :
ESTIMATED
End Date :
December 1 2023
Estimated Enrollment :
200 Patients enrolled
Trial Details
Trial ID
NCT04277702
Start Date
May 1 2020
End Date
December 1 2023
Last Update
February 20 2020
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