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Study on Managing Heart Attack Risk with Icosapent Ethyl and Drug Combination for Patients at High Risk of Another Heart Attack

Recommended centreFast replyRegistered drugNo placebo
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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 patients who have experienced an Acute Myocardial Infarction, commonly known as a heart attack. The study aims to explore the effectiveness of a more intensive approach to managing risk factors for heart-related issues compared to standard treatments. The trial will involve the use of several medications, including Vazkepa (which contains the active ingredient icosapent ethyl), Colchicine, and empagliflozin. These medications are taken orally and are intended to help reduce the risk of further heart problems.

The purpose of the study is to evaluate how well these treatments work in preventing serious heart-related events, such as heart attacks, strokes, and heart failure. Participants in the study will be randomly assigned to receive either the intensified treatment or the standard treatment. The study will monitor the time it takes for participants to experience any major heart-related events, such as cardiovascular death, non-fatal heart attacks, or hospitalizations due to heart issues.

The trial is expected to run for several years, with the goal of gathering enough data to determine the effectiveness of the intensified treatment approach. By participating in this study, researchers hope to find better ways to manage heart health and prevent future heart-related problems in individuals who have already experienced a heart attack.

The research process

The trial runs in 6 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, participants must provide written consent after being fully informed about the trial. This is a crucial step to ensure understanding and agreement to participate.

    Eligibility is confirmed based on specific criteria, including being over 18 years of age and having undergone a percutaneous coronary intervention (PCI) procedure for an acute myocardial infarction within 48 hours to 14 days prior.

  2. Step 2

    Initial assessment

    Participants undergo an initial assessment to gather baseline data. This includes evaluating the BIO-RISK-EVENT score parameters, which are necessary for the study.

  3. Step 3

    Medication administration

    Participants are assigned to receive specific medications as part of the trial. These include Vazkepa 998 mg soft capsules, colchicine, and empagliflozin. All medications are taken orally.

    The dosage, frequency, and duration of administration are determined by the study protocol and are explained to participants during this phase.

  4. Step 4

    Ongoing monitoring

    Participants are monitored regularly to assess the efficacy of the treatment. This involves tracking the time to the first event of a composite of cardiovascular outcomes, such as cardiovascular death, non-fatal myocardial infarction, non-fatal stroke, hospitalization for urgent coronary revascularization, and hospitalization for heart failure.

    Secondary outcomes are also monitored, including time to cardiovascular death, all-cause mortality, and other specific cardiovascular events.

  5. Step 5

    Follow-up visits

    Regular follow-up visits are scheduled to evaluate the participant's health status and any changes in their condition. These visits are crucial for collecting data and ensuring participant safety.

  6. Step 6

    Completion of the study

    The study is estimated to conclude by June 30, 2028. Participants will be informed about the end of the study and any necessary steps to transition out of the trial.

Who can join the trial?

4 criteria

  • Individuals must be over 18 years of age.
  • Participants must provide written consent after being informed about the study.
  • Participants must have undergone a percutaneous coronary intervention (PCI) procedure for acute myocardial infarction. This is a medical procedure used to open up blood vessels in the heart that have been narrowed by plaque buildup. The inclusion window for this is 48 hours to 14 days after the PCI.
  • Participants must have BIO-RISK-EVENT score parameters available. This refers to specific health measurements used to assess risk.

Who cannot join the trial?

3 criteria

  • Patients who have had a recent Acute Myocardial Infarction (a heart attack) cannot participate.
  • Patients who are not within the specified age range for the study cannot participate.
  • Patients who are part of a vulnerable population, such as those unable to give consent, are not eligible.
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Investigated drugs

  • Vazkepa

    is a soft‑gel capsule that contains icosapent ethyl, a type of omega‑3 fatty acid. In the study it is used to see if adding this omega‑3 can further lower the risk of future heart problems when people are already receiving standard heart‑health care.

  • Colchicine

    is an oral medicine that includes colchicine along with small amounts of opium powder and tiemonium methylsulphate. It is being tested for its ability to reduce inflammation, which may help prevent new heart events in patients who are at high risk.

  • Empagliflozin

    is a tablet that lowers blood sugar by helping the kidneys remove excess glucose. In the trial it is used to determine whether better blood‑sugar control can also lower the chance of another cardiovascular event when combined with other risk‑reduction strategies.

What is already known about the treatment

  • Vazkepa 998 mg soft capsules

    This medication is taken by mouth as a soft gelatin capsule. Icosapent ethyl is a prescription omega‑3 fatty acid that is approved to lower high triglyceride levels and is being studied for reducing heart risk after a heart attack. It works by decreasing the amount of fat in the blood and also has mild anti‑inflammatory effects. It belongs to the class of omega‑3‑triglyceride drugs.

  • Colchicine

    The product is an oral tablet that contains colchicine together with small amounts of opium powder and tiemonium methylsulphate. Colchicine is an approved medicine for gout attacks and has been shown to lower inflammation in certain heart conditions; the added opium provides pain relief while tiemonium helps relax smooth muscle. The colchicine component blocks the activity of white‑blood‑cell proteins that cause inflammation. This combination is classified as an anti‑inflammatory and antispasmodic therapy.

  • Empagliflozin

    Empagliflozin is taken orally as a tablet. It is an approved drug for type 2 diabetes and is also used to lower the risk of heart failure and kidney problems in people with cardiovascular disease. It works by stopping a kidney protein (SGLT2) from re‑absorbing sugar, so excess sugar is eliminated in the urine, which helps lower blood sugar and reduces heart strain. It belongs to the class of SGLT2‑inhibitor medicines.

Investigated diseases

Acute Myocardial Infarction – Acute Myocardial Infarction, commonly known as a heart attack, occurs when blood flow to a part of the heart is blocked for a long enough time that part of the heart muscle is damaged or dies. This blockage is often due to a buildup of fat, cholesterol, and other substances, which form a plaque in the coronary arteries. As the plaque breaks, a blood clot forms, which can obstruct the flow of blood. The progression of the disease involves the death of heart muscle tissue due to the lack of oxygen-rich blood. Symptoms may include chest pain, shortness of breath, and other discomforts. Over time, this can lead to complications such as heart failure or arrhythmias.
Trial detailsLast updated 30 Oct 2026
Age18+ yearsPhasePhase IIITrial ID2024-511950-35-00Protocol codeFIMM-2024-02Estimated enrolment1 758 patientsSponsorMedical University Of Graz

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