Peripheral Arterial DiseasePhase 3CADET-PADNCT04277702
Cysteinyl Leukotriene Antagonist in Atherosclerosis Inhibition in Patients After Endovascular Treatment Due to Peripheral Arterial Disease
A Phase 3 study testing Montelukast 10mg, Endovascular treatment and Standard anti-platelet treatment in people with Peripheral Arterial Disease and Peripheral Vascular Diseases, run by Jagiellonian University.
Trial 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 significant challenge for diagnostics and pharmacology. Read more about this study
- Who is it for?
- Ages 45 to 75 years
- Conditions the study is for
- Peripheral Arterial Disease, Peripheral Vascular Diseases, Lower Limb Ischemia
- What is being tested?
- Montelukast 10mg, Endovascular treatment and Standard anti-platelet treatment
- Type of treatment
- Pill or oral medicine, Surgery or procedure
- Could I receive a placebo?
- Yes, some participants may receive a placebo
- How many people
- 200 participants
- Where
- No sites listed yet
- Study dates
- May 2020to Dec 2023
- Phase
- Phase 3
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 45 to 75 years
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- Patients with peripheral arterial disease qualified for endovascular treatment with Rutherford 3 or 4 clinical symptoms.
- Age 45 - 75 years old.
- Signed informed consent.
Who cannot join
- 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+.
Show all 21Show fewer
- 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.
Trial locations and contacts
No sites are listed yet.
About this study
Official title: The Assessment of Cysteinyl Leukotriene Receptor Antagonist Role in Inhibition of Atherosclerosis, Proliferation and Its Influence on Endothelial Function in Patients Undergoing Endovascular Treatment Due to Peripheral Arterial Disease.
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 significant challenge for diagnostics and pharmacology. This disease occurs in over 60% of the population over 70 years old. There are many factors that are responsible for this process including group of the arachidonic acid metabolism products - leukotriens, especially leukotriene E4 (LTE4). The effect of these factors was described as the base of pathology not only cardiovascular diseases but also the base of development of asthma and other allergic diseases. The substance which blocks the activity of these factors - montelukast - is a common method of treatment in asthma.
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.
Read more
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.
- Conditions
- Peripheral Arterial Disease, Peripheral Vascular Diseases, Lower Limb Ischemia, Atherosclerosis of Artery
- Being tested
- Montelukast 10mg, Endovascular treatment, Standard anti-platelet treatment
- Keywords
- atherosclerosis, Peripheral Arterial Disease, Montelukast, Leukotrienes
- Medical subject headings
- Peripheral Arterial Disease, Peripheral Vascular Diseases, Atherosclerosis
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Montelukast 10mgDrug
Oral administration of 10mg of montelukast daily for 12 months
Endovascular treatmentProcedure or surgery
Percutaneous transluminal angioplasty combined with bare-metal stenting of lower limbs arteries
Standard anti-platelet treatmentDrug
Standard antithrombotic treatment for patients undergoing endovascular procedures
| Study group | Role | What they receive |
|---|---|---|
| Montelukast + standard treatment | Experimental | Not described Receives: Drug: Montelukast 10mg; Procedure: Endovascular treatment; Drug: Standard anti-platelet treatment |
| Placebo+ standard treatment | Placebo comparator | Not described Receives: Procedure: Endovascular treatment; Drug: Standard anti-platelet treatment |
What is being measured
The primary outcome is the main question the study is designed to answer.
Failure of endovascular treatment (Target Vessel Failure)
Hemodynamically significant restenosis or reocclusion of the treated vessel
Measured: 12 months
Secondary outcomes (6)
Death
Measured: 12 months
Myocardial Infarction
Measured: 12 months
Stroke
Measured: 12 months
Combined MACEs
Occurrence of any major adverse cardiovascular event
Measured: 12 months
Treated limb amputation
Large amputation of the treated limb
Measured: 12 months
Significant decrease of life quality
Significant decrease of life quality in patients undergoing treatment measured by the Vascu-Qol and Walking Impairment Questionnaire
Measured: 12 months
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted20 Feb 2020
- Study startMay 2020 (estimated)
- Primary completionOct 2023 (estimated)
- Study completionDec 2023 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Peripheral Arterial DiseaseStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase 3
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Quadruple blind
- Who is masked
- Participant, Care provider, Investigator, Outcomes assessor
- Enrolment
- 200 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Jagiellonian University
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Pawel Maga, Jagiellonian University
- Investigators
- Pawel Maga, Prof, Principal investigator, Angiology Department, Jagiellonian University Medical College
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT04277702
- Sponsor's protocol ID
- CADET-PAD
- Other IDs
- 2020-000715-71
- Acronym
- CADET-PAD
- Status last verified
- Feb 2020
- First submitted
- 18 Feb 2020
- Last updated
- 20 Feb 2020
- Results posted
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- Yes
Study at a glance
From the registry record, last updated by the sponsor on 20 Feb 2020. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- The Assessment of Cysteinyl Leukotriene Receptor Antagonist Role in Inhibition of Atherosclerosis, Proliferation and Its Influence on Endothelial Function in Patients Undergoing Endovascular Treatment Due to Peripheral Arterial Disease.
- ClinicalTrials.gov ID
- NCT04277702
- Acronym / sponsor ID
- CADET-PAD / CADET-PAD
- Conditions
- Peripheral Arterial Disease, Peripheral Vascular Diseases, Lower Limb Ischemia, Atherosclerosis of Artery
- Keywords
- atherosclerosis, Peripheral Arterial Disease, Montelukast, Leukotrienes
- Phase
- Phase 3
- Study type
- Interventional
- Recruitment status
- Unknown status
- Enrolment
- 200 participants (estimated)
- Lead sponsor
- Jagiellonian UniversityUniversity, hospital or other
- Study start
- May 2020 (estimated)
- Primary completion
- Oct 2023 (estimated)
- Study completion
- Dec 2023 (estimated)
- First posted
- 20 Feb 2020 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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 significant challenge for diagnostics and pharmacology. This disease occurs in over 60% of the population over 70 years old. There are many factors that are responsible for this process including group of the arachidonic acid metabolism products - leukotriens, especially leukotriene E4 (LTE4). The effect of these factors was described as the base of pathology not only cardiovascular diseases but also the base of development of asthma and other allergic diseases. The substance which blocks the activity of these factors - montelukast - is a common method of treatment in asthma.
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.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Quadruple blind (participant, care provider, investigator, outcomes assessor)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Montelukast + standard treatment | Experimental | Drug: Montelukast 10mg, Procedure: Endovascular treatment, Drug: Standard anti-platelet treatment |
| Placebo+ standard treatment | Placebo comparator | Procedure: Endovascular treatment, Drug: Standard anti-platelet treatment |
Who may qualify
- Ages
- 45 to 75 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (3 listed)
- Patients with peripheral arterial disease qualified for endovascular treatment with Rutherford 3 or 4 clinical symptoms.
- Age 45 - 75 years old.
- Signed informed consent.
Key exclusion criteria (21 listed)
- 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)
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| Montelukast 10mgOral administration of 10mg of montelukast daily for 12 months | Drug | Montelukast + standard treatment |
| Endovascular treatmentPercutaneous transluminal angioplasty combined with bare-metal stenting of lower limbs arteries | Procedure or surgery | Montelukast + standard treatment, Placebo+ standard treatment |
| Standard anti-platelet treatmentStandard antithrombotic treatment for patients undergoing endovascular procedures | Drug | Montelukast + standard treatment, Placebo+ standard treatment |
Primary outcome
Failure of endovascular treatment (Target Vessel Failure)
Time frame: 12 months
Hemodynamically significant restenosis or reocclusion of the treated vessel
6 secondary outcomes
Death
Time frame: 12 months
Myocardial Infarction
Time frame: 12 months
Stroke
Time frame: 12 months
Combined MACEs
Time frame: 12 months
Treated limb amputation
Time frame: 12 months
Significant decrease of life quality
Time frame: 12 months
Results and safety
Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 20 Feb 2020.
- Individual participant dataSharing planned: Yes
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Pawel Maga, Prof principal investigator
Angiology Department, Jagiellonian University Medical College
Questions about this trial
What is this clinical trial studying?
A Phase 3 study testing Montelukast 10mg, Endovascular treatment and Standard anti-platelet treatment in people with Peripheral Arterial Disease and Peripheral Vascular Diseases, run by Jagiellonian University.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 3 inclusion and 21 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: status not confirmed, as of the sponsor's last update on 20 Feb 2020. Status can change between updates, so confirm with the study contact before making plans.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. Some participants in this study may receive a placebo. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
What does this phase mean?
Phase 3 studies compare the treatment with the current standard treatment or a placebo in a large group, to confirm how well it works and watch for side effects.
Not every study follows the same path, and some studies (observational studies, device studies) have no phase.
Are results available for this study?
Results are not available in the source record.
How can a doctor refer a patient or contact the research team?
Contact Pawel Maga, Prof (+48692814418, maga.pawel@gmail.com), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Failure of endovascular treatment (Target Vessel Failure) (time frame: 12 months). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 20 Feb 2020.