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Study on Montelukast for Patients with Peripheral Artery Disease Undergoing Endovascular Treatment

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What is this trial about?

A plain-language summary of the goals, design and what participants do

This clinical trial is focused on studying the effects of a medication called montelukast on patients with peripheral artery disease, a condition where the arteries in the legs become narrowed or blocked, leading to reduced blood flow. The study aims to understand how montelukast, which is a type of medication known as a cysteinyl leukotriene receptor antagonist, can help prevent the re-narrowing of arteries after they have been treated with a procedure called endovascular treatment. This procedure is used to open up blocked arteries and improve blood flow in the legs.

Participants in the study will receive either montelukast or a placebo. The study will observe the effects of the medication over a period of time to see if it helps in reducing the rate of artery re-narrowing, also known as restenosis. The study will also look at other outcomes such as major adverse cardiovascular events (MACE), the need for high lower limb amputation, and changes in the quality of life of the participants.

The purpose of this study is to explore the potential benefits of using montelukast in patients who have undergone endovascular treatment for peripheral artery disease. By understanding its effects, researchers hope to find better ways to manage this condition and improve the health and well-being of patients affected by it.

The research process

The trial runs in 5 steps – from screening to follow-up. Each step says what happens and what the team monitors.

  1. Step 1

    Joining the study

    Upon joining the study, eligibility is confirmed based on specific criteria such as age between 45 and 75 years, diagnosis of peripheral artery occlusive disease (PAOD), and residency in the Malopolska region.

    Informed consent is required to participate in the study.

  2. Step 2

    Initial assessment

    An initial assessment is conducted to evaluate the condition of the lower limb arteries and to document any symptoms related to obstructive artery disease.

    This assessment helps in establishing a baseline for future comparisons.

  3. Step 3

    Medication administration

    The medication used in the study is Asmenol, which contains montelukast. It is administered in the form of a film-coated tablet.

    The dosage is 10 mg per tablet, taken orally once daily.

    The duration of medication administration is aligned with the study's timeline, which is expected to conclude by February 2026.

  4. Step 4

    Ongoing monitoring

    Regular monitoring is conducted to assess the impact of the medication on the arteries and to check for any signs of restenosis, which is the re-narrowing of a previously treated artery.

    Monitoring also includes evaluating the overall health and quality of life of the participant.

  5. Step 5

    Final evaluation

    At the end of the study, a comprehensive evaluation is performed to determine the effectiveness of the treatment in preventing artery reocclusion.

    The final evaluation also considers any major adverse cardiovascular events (MACE) and the participant's quality of life.

Who can join the trial?

7 criteria

  • Patients must have PAOD. This stands for Peripheral Artery Occlusive Disease, which is a condition where the arteries in the legs are narrowed or blocked.
  • Patients should be qualified for PTA. This means Percutaneous Transluminal Angioplasty, a procedure to open blocked blood vessels.
  • Patients must have Rutherford 3 or 4 clinical symptoms. This refers to a scale used to describe the severity of symptoms in PAOD, with 3 or 4 indicating moderate to severe symptoms.
  • Patients must be between 45 and 75 years old.
  • Patients need to have signed informed consent, meaning they agree to participate in the study after understanding what it involves.
  • Patients must be a citizen of the Malopolska region.
  • Both male and female patients can participate.

Who cannot join the trial?

4 criteria

  • Patients who have a different medical condition than the one being studied, which is ischemia of the lower limbs due to blocked arteries.
  • Patients who are not within the specified age range for the study.
  • Patients who belong to a vulnerable population, which means they might need special protection or care.
  • Patients who do not meet other specific criteria set by the study organizers.
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Investigated drugs

Cysteinyl Leukotriene Receptor Antagonist is a medication used in this study to explore its potential benefits in patients with peripheral artery occlusive disease. The focus is on understanding how this medication might help prevent the re-narrowing of arteries in the lower limbs after they have been treated with a procedure to open them up. This medication works by blocking certain substances in the body that can cause inflammation and narrowing of the blood vessels, which may help improve blood flow and reduce the risk of arteries becoming blocked again.

What is already known about the treatment

Cysteinyl Leukotriene Receptor Antagonist – This medication is administered orally and is currently being studied for its potential benefits in treating ischemia of the lower limbs due to obstructive artery disease. It is primarily used to explore its role in reducing the reocclusion rate of arteries in patients with peripheral artery occlusive disease following endovascular treatment. The drug works by blocking cysteinyl leukotriene receptors, which are involved in inflammatory processes that can lead to atherosclerosis and vascular proliferation. It is classified as a leukotriene receptor antagonist, a type of anti-inflammatory medication.

Investigated diseases

Peripheral Artery Occlusive Disease – This condition involves the narrowing or blockage of arteries in the lower limbs, often due to atherosclerosis, which is the buildup of fatty deposits on the artery walls. As the disease progresses, it can lead to reduced blood flow to the legs and feet, causing symptoms such as pain, cramping, or fatigue in the legs during physical activities. Over time, the reduced blood flow can result in more severe symptoms, including pain at rest, non-healing wounds, or ulcers on the feet or legs. If left untreated, the condition can lead to significant complications, such as tissue damage or gangrene. The disease typically progresses slowly, and symptoms may worsen gradually over time.
Trial detailsLast updated 2 Oct 2026
Age18+ yearsPhasePhase IIITrial ID2024-511894-32-00Protocol codeCADET-PADEstimated enrolment200 patientsSponsorUniwersytet Jagiellonski Collegium Medicum

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