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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

Verified siteRegistered drugNo placebo

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Wojskowy Instytut Medyczny Państwowy Instytut Badawczy
Verified & featuredResponsive
Warsaw, Poland
Not recruiting

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.

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.
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.
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.
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.
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.
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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Verified sites

All sites with verified contact details – recruitment status may not be available; ask directly

Wojskowy Instytut Medyczny Państwowy Instytut Badawczy
Verified & featuredResponsive
Warsaw, Poland
Not recruiting
Landeskrankenanstalten-Betriebsgesellschaft Kabeg
Responsive
Klagenfurt am Wörthersee, Austria
Uniwersyteckie Centrum Kliniczne Warszawskiego Uniwersytetu Medycznego
Responsive
Warsaw, Poland

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Investigated drugs

Atorvastatin is a medication used to lower cholesterol levels in the blood. It works by reducing the amount of cholesterol made by the liver, which helps prevent heart disease and stroke. In this trial, it is used to manage cardiovascular risk factors in patients who are at high risk for recurrent cardiovascular events.

Ramipril is a medication that helps relax blood vessels, making it easier for the heart to pump blood around the body. It is used to treat high blood pressure and heart failure, and it can also help prevent future heart attacks and strokes. In this trial, it is part of the strategy to manage cardiovascular risk factors.

Aspirin is a common medication that helps prevent blood clots. It is often used to reduce the risk of heart attacks and strokes in people with cardiovascular disease. In this trial, aspirin is used to help manage the risk of recurrent cardiovascular events.

Metformin is a medication commonly used to treat type 2 diabetes. It helps control blood sugar levels and can also have beneficial effects on heart health. In this trial, metformin is included as part of the management of cardiovascular risk factors.

Empagliflozin is a medication used to lower blood sugar levels in people with type 2 diabetes. It also has benefits for heart health, including reducing the risk of heart failure. In this trial, empagliflozin is used to help manage cardiovascular risk factors in patients.

What is already known about the treatment

Medication Name – This medication is administered orally in the form of tablets. It is currently being studied in clinical trials to assess its effectiveness in managing cardiovascular risk factors in patients who have a high risk of recurrent cardiovascular events, such as acute myocardial infarction. The main therapeutic indication is to reduce the risk of further heart-related issues by managing residual risk factors. At the molecular level, the medication works by targeting specific pathways that contribute to cardiovascular risk, helping to stabilize heart function and prevent further damage. It is classified pharmacologically as a cardiovascular agent.

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.