Cysteinyl Leukotriene Antagonist in Atherosclerosis Inhibition in Patients After Endovascular Treatment Due to Peripheral Arterial Disease
NCT ID: NCT04277702
Last Updated: 2020-02-20
Study Results
The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.
Basic Information
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UNKNOWN
PHASE3
200 participants
INTERVENTIONAL
2020-05-31
2023-12-31
Brief Summary
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The aim of this project is to investigate the influence of cysteinyl leukotriens receptor antagonists on lower limb arteries reocclusion rate in patients with peripheral artery disease (PAD) after endovascular treatment.
During previous years we conducted a prospective study, which helped us evaluating the dynamics of leukotriens and thromboxane levels in patients with PAD, who underwent endovascular treatment - peripheral transluminal angioplasty (PTA). We established for the first time the dependence between the increased level of LTE4 in urine (uLTE4) and restenosis or reocclusion occurrence, which translates to the necessity of further procedures and a decrease in the quality of life. We should ask ourselves a question: Is blocking of cysteinyl leukotriens reaction as proinflammatory and proliferative factors, by the use of receptor CysLT1 antagonists going to decrease the quantity of restenosis and reocclusions after endovascular treatment? Within the project performed in the Angiology Department of Jagiellonian University among the patients suffering from PAD and fulfilling all inclusion criteria, the randomized double-blinded clinical study will be performed. Patients will be assigned to two groups: Treatment Group (which will be receiving cysteinyl leukotriene antagonist (montelukast) in a dose of 10mg/day for 12 months) and Control Group to which placebo will be administered. Among all patients population, at every visit at 1., 3., 6., and 12-month clinical state, ultrasound, hemodynamic parameters, and endothelium imaging will be performed as well as uLTE4 measurements. A comparison of the results between both groups will give us an answer if blocking uLTE4 receptors may become a breakthrough in future atherosclerosis treatment.
The mechanisms, which lead to restenosis is still not fully understood, and currently used methods of treatment - antiplatelets, anti-proliferative drugs, and anticoagulants - are not fully effective. Thanks to this research the knowledge about treatment and prevention of atherosclerosis will be increased, which will be connected with future better patient care, especially patients with PAD.
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Detailed Description
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Conditions
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Study Design
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RANDOMIZED
PARALLEL
TREATMENT
QUADRUPLE
Study Groups
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Montelukast + standard treatment
Montelukast 10mg
Oral administration of 10mg of montelukast daily for 12 months
Endovascular treatment
Percutaneous transluminal angioplasty combined with bare-metal stenting of lower limbs arteries
Standard anti-platelet treatment
Standard antithrombotic treatment for patients undergoing endovascular procedures
Placebo+ standard treatment
Endovascular treatment
Percutaneous transluminal angioplasty combined with bare-metal stenting of lower limbs arteries
Standard anti-platelet treatment
Standard antithrombotic treatment for patients undergoing endovascular procedures
Interventions
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Montelukast 10mg
Oral administration of 10mg of montelukast daily for 12 months
Endovascular treatment
Percutaneous transluminal angioplasty combined with bare-metal stenting of lower limbs arteries
Standard anti-platelet treatment
Standard antithrombotic treatment for patients undergoing endovascular procedures
Eligibility Criteria
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Inclusion Criteria
2. Age 45 - 75 years old.
3. Signed informed consent.
Exclusion Criteria
2. Age \< 45 or \> 75 years old.
3. 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.
4. Symptoms of acute tissue infection
5. Chronic inflammatory disease (e.g. COPD stage \>II in GOLD classification)
6. HIV+, HCV+, HBS+.
7. Autoimmunological diseases and use of steroids or immunosuppressive medications within the last 3 months.
8. Inflammatory blood vessel disorders (with exception of atherosclerosis)
9. Myocardial infarction or stoke within last 6 months.
10. Buerger Disease.
11. Chronic heart failure (3-4 NYHA)
12. Acute lower limb ischemia or surgical revascularization within last 6 months.
13. Serious trauma or surgery procedure within last 6 months.
14. Asthma.
15. On-going antileukotriene treatment.
16. Neoplasm diagnosed within 5 years.
17. Chronic Kidney Disease (creat. \>177 µmol/l).
18. Pregnancy, puerperium, women without efficient contraception.
19. Vaccinations within 30 days before recruitment.
20. Hospitalisation in intensive care unit within 3 months.
21. Lack of the possibility of the follow-up participation.
45 Years
75 Years
ALL
No
Sponsors
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Jagiellonian University
OTHER
Responsible Party
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Pawel Maga
Prof.
Principal Investigators
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Pawel Maga, Prof
Role: PRINCIPAL_INVESTIGATOR
Angiology Department, Jagiellonian University Medical College
Central Contacts
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Other Identifiers
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2020-000715-71
Identifier Type: EUDRACT_NUMBER
Identifier Source: secondary_id
CADET-PAD
Identifier Type: -
Identifier Source: org_study_id
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