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Study on Colchicine for Patients with Coronary Artery Disease After Percutaneous Coronary Intervention

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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 coronary artery disease who have undergone a procedure known as percutaneous coronary intervention (PCI). Coronary artery disease is a condition where the blood vessels supplying the heart become narrowed or blocked, which can lead to chest pain or heart attacks. Percutaneous coronary intervention is a treatment that helps open up these blocked blood vessels. The study aims to see if taking Colchicine daily can reduce the risk of serious heart-related events such as heart attacks, strokes, or the need for further procedures to open up the heart's blood vessels.

Participants in the study will be randomly assigned to receive either Colchicine or a placebo, which looks like the medication but does not contain the active ingredient. The study will follow participants over time to monitor their health and any heart-related events they may experience. The goal is to determine if Colchicine can help improve outcomes for people with coronary artery disease after they have had PCI.

The study will track the time it takes for participants to experience any major heart-related events, such as heart attacks or strokes, and will also assess changes in symptoms like chest pain and shortness of breath. This research is important for understanding how Colchicine might benefit patients with coronary artery disease and potentially improve their quality of life.

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 (45 years or older) and having coronary artery disease treated with a procedure called percutaneous coronary intervention (PCI).

    Additional risk factors are assessed, including diabetes, smoking, high blood pressure, cholesterol levels, and history of vascular disease.

    Enrollment occurs between 2 hours and 5 days after the PCI procedure.

  2. Step 2

    Randomization

    Participants are randomly assigned to receive either the active medication, colchicine, or a placebo.

    The active medication is colchicine 0.5 mg, taken orally in tablet form.

  3. Step 3

    Medication administration

    The assigned medication, either colchicine or placebo, is taken once daily.

    The duration of medication administration continues throughout the study period, which is estimated to end by August 2027.

  4. Step 4

    Monitoring and follow-up

    Participants are monitored for the occurrence of specific health events, including death from any cause, heart attack, stroke, or the need for additional coronary procedures.

    Regular assessments are conducted to evaluate health status and any changes in symptoms related to coronary artery disease.

  5. Step 5

    Completion of study

    The study concludes with a final evaluation of health outcomes and any changes in symptoms or quality of life.

    The primary goal is to determine if colchicine reduces the risk of major cardiovascular events compared to placebo.

Who can join the trial?

16 criteria

  • Must be **45 years** or older.
  • Have **coronary artery disease** treated with **PCI** (a procedure to open blocked heart arteries) and be on optimal medical therapy.
  • Have at least one additional risk factor, such as:
    • **Diabetes mellitus** (a condition where blood sugar levels are too high), either currently being treated or newly diagnosed with **HbA1c** (a blood test that shows average blood sugar levels over the past 3 months) of 6.5% or higher.
    • Currently **smoking**.
    • **Treated hypertension** (high blood pressure) or having a systolic blood pressure (the top number) of 140 mmHg or higher, or a diastolic blood pressure (the bottom number) of 90 mmHg or higher.
    • **Total cholesterol** greater than 240 mg/dl if untreated, or treated **LDL** (bad cholesterol) greater than 70 mg/dl.
    • **HDL** (good cholesterol) less than 40 mg/dl.
    • **hsCRP** (a blood test that measures inflammation) greater than 2 mg/dl and having a **chronic coronary syndrome** (a long-term heart condition).
    • **eGFR** (a test that measures kidney function) less than 60 ml/min.
    • History of **vascular disease**, such as:
      • **CAD** (coronary artery disease) with previous PCI, **CABG** (heart bypass surgery), or **MI** (heart attack).
      • **Stroke** (either ischemic, caused by a blockage, or hemorrhagic, caused by bleeding).
      • **Carotid artery revascularisation** (a procedure to restore blood flow in the neck arteries).
      • **PAD** (peripheral artery disease) with revascularisation, **ABI** (a test for blood flow in the legs) less than 0.85 at rest, or amputation due to atherosclerotic disease (narrowing of the arteries).
      • **AAA** (abdominal aortic aneurysm) repair or having a distal aortic anteroposterior diameter greater than 3.0 cm.
      • Able to be enrolled or randomized between 2 hours and 5 days after **PCI**.
      • Must provide **written informed consent** (agreeing to participate after being informed about the study).

Who cannot join the trial?

7 criteria

  • Patients who have a history of severe allergic reactions to the study medication.
  • Patients with severe liver disease, which means the liver is not working properly.
  • Patients with severe kidney disease, which means the kidneys are not working properly.
  • Patients who are pregnant or breastfeeding.
  • Patients who are currently participating in another clinical trial.
  • Patients with a history of alcohol or drug abuse.
  • Patients with any other medical condition that the study doctors think would make it unsafe for them to participate.
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Investigated drugs

Colchicine is a medication used in this trial to see if it can help reduce the risk of serious heart problems in patients who have coronary artery disease and have undergone a procedure called Percutaneous Coronary Intervention (PCI). The study aims to find out if taking colchicine daily can lower the chances of events like heart attacks, strokes, or the need for further heart procedures.

What is already known about the treatment

Colchicine – Colchicine is administered orally in tablet form. It is currently being studied for its potential benefits in patients with coronary artery disease, particularly after undergoing a procedure known as percutaneous coronary intervention. The main therapeutic indication being explored is its ability to reduce the risk of serious cardiovascular events such as heart attacks and strokes. At the molecular level, colchicine works by inhibiting certain proteins that contribute to inflammation, which may help in reducing the risk of these events. It is classified pharmacologically as an anti-inflammatory agent.

Investigated diseases

Coronary Artery Disease – This condition occurs when the major blood vessels that supply the heart with blood, oxygen, and nutrients become damaged or diseased, primarily due to the buildup of cholesterol and other substances, known as plaque, on the artery walls. Over time, this plaque can harden or rupture, leading to narrowed or blocked arteries, which reduces blood flow to the heart. As the disease progresses, it can cause chest pain (angina), shortness of breath, or other symptoms. If a coronary artery becomes completely blocked, it can result in a heart attack. The progression of the disease can vary, with some individuals experiencing symptoms early on, while others may not notice any signs until the disease is advanced. Regular monitoring and lifestyle changes can help manage the condition.
Trial detailsLast updated 7 Oct 2026
Age18+ yearsPhasePhase IIITrial ID2023-505028-74-00Protocol codeCOL BE PCIEstimated enrolment2 770 patientsSponsorAz St-Jan Brugge-Oostende A.V.

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