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Study on Low-Dose Colchicine for Patients with Peripheral Artery Disease to Reduce Cardiovascular Risks

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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 Colchicine in patients with Peripheral Artery Disease (PAD). Peripheral Artery Disease is a condition where the blood vessels outside the heart and brain become narrowed, often leading to reduced blood flow to the limbs. The study will use Colchicine Tiofarma 500 microgram Tablets, which is a low-dose form of the medication, to see if it can help reduce the risk of serious heart and blood vessel problems in people with this condition.

The purpose of the study is to examine how effective and safe Colchicine is in lowering the chances of events like heart attacks, strokes, or severe issues with blood flow to the limbs that might require medical procedures or even amputation. Participants in the study will either receive the Colchicine tablets or a placebo, which looks like the medication but does not contain the active ingredient. The study will last for a period of time, during which participants will take the tablets daily and be monitored for any changes in their health.

Throughout the study, researchers will keep track of various health outcomes, such as the occurrence of heart-related events, hospitalizations, and any need for medical procedures to improve blood flow. The goal is to determine if taking Colchicine can help improve the quality of life and reduce the risk of serious complications for people living with Peripheral Artery Disease.

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, the patient will be informed about the trial's purpose and procedures. Written informed consent is required to participate.

  2. Step 2

    Initial assessment

    An initial assessment will be conducted to confirm eligibility. This includes checking for symptoms of peripheral arterial disease, such as intermittent claudication or rest pain, and verifying medical history.

  3. Step 3

    Medication administration

    The patient will receive either Colchicine Tiofarma 500 microgram Tablets or a placebo. The medication is taken orally once daily. The purpose is to evaluate the effectiveness of colchicine in reducing cardiovascular events.

  4. Step 4

    Regular follow-up visits

    Regular follow-up visits will be scheduled to monitor the patient's health and any side effects. These visits will include assessments of cardiovascular health and limb condition.

  5. Step 5

    End of study evaluation

    At the end of the study, a final evaluation will be conducted. This will assess the overall impact of the medication on cardiovascular and limb health.

Who can join the trial?

9 criteria

  • Must be over 18 years old.
  • Have symptoms of **atherosclerotic** **LE PAD** (Peripheral Arterial Disease in the legs) and meet at least one of the following conditions:
    • Experience **intermittent claudication**, which means pain in the legs during walking, with an **ankle/arm blood pressure ratio** (ABI) of 0.90 or less, or have an artery that is narrowed by 50% or more. Additionally, must have one of the following:
      • More than one area in the body affected by **atherosclerosis** (a condition where arteries become narrowed and hardened).
      • Have **diabetes**.
      • Have **heart failure**.
      • Have **chronic kidney disease** with an **eGFR** (a test that measures kidney function) of less than 60 mL/min/1.73 m².
      • Experience **rest pain** (pain mostly in the foot), or have **necrosis** (tissue death) of the limb, or **gangrene** (severe tissue damage) of the limb, corresponding to specific medical stages. Must also have an **ankle/arm blood pressure ratio** (ABI) of 0.90 or less, or an artery that is narrowed by 50% or more. If the ankle arteries cannot be compressed, a **toe pressure** of 60 mm Hg or less, or a **toe-brachial index** of 0.70 or less, is acceptable.
      • Have undergone **revascularization**, which is a procedure to restore blood flow, such as limb bypass surgery or other procedures to open up blocked arteries.
      • Have had a leg or foot **amputation** due to problems with blood flow in the arteries.
      • Must provide **written informed consent**, meaning they agree to participate in the study after being fully informed about it.

Who cannot join the trial?

3 criteria

  • Patients who do not have peripheral arterial disease cannot participate. This is a condition where the blood vessels outside the heart and brain become narrowed or blocked.
  • Patients who are not within the specified age range cannot participate. The age range includes adults and older adults.
  • Patients who are part of a vulnerable population cannot participate. This means people who might need special protection or care.
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Investigated drugs

Colchicine is a medication being studied in this trial for its potential to reduce the risk of serious cardiovascular events. These events include heart attacks, strokes, and severe problems with blood flow in the limbs that might require surgery. The trial is focused on patients with peripheral artery disease, a condition that affects blood flow in the arteries. The goal is to see if colchicine can help lower the chances of these serious health issues.

What is already known about the treatment

Colchicine – Colchicine is administered orally in the form of tablets. It is currently being studied in clinical trials for its potential benefits in patients with peripheral arterial disease (PAD). The main therapeutic indication being explored is the reduction of cardiovascular events such as heart attack, stroke, and severe limb ischemia in these patients. At the molecular level, colchicine works by inhibiting microtubule polymerization, which reduces inflammation and may help prevent vascular complications. It is classified pharmacologically as an anti-inflammatory agent.

Investigated diseases

Peripheral Arterial Disease – This condition involves the narrowing or blockage of the arteries, primarily affecting the legs. It occurs when fatty deposits build up on the walls of the arteries, reducing blood flow to the limbs. As the disease progresses, individuals may experience pain or cramping in the legs or hips, especially during physical activities like walking or climbing stairs. Over time, the symptoms can worsen, leading to more severe pain even at rest. In advanced stages, the reduced blood flow can cause wounds or sores on the feet or legs that heal slowly or not at all. If left unchecked, it can lead to critical limb ischemia, where the lack of blood flow becomes a serious concern.
Trial detailsLast updated 7 Oct 2026
Age18+ yearsPhasePhase IIITrial ID2024-512091-35-01Estimated enrolment7 750 patientsSponsorHamilton Health Sciences Corporation

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