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

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What is this study about?

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.

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 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 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 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 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 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 Study?

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 Study?

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.

Where you can join this trial?

Verified and Recommended Sites

No sites found in this category

Verified Sites

Site Name	City	Country
Bezirkskrankenhaus St. Johann	St. Johann in Tirol	Austria
Kardinal Schwarzenberg Klinikum GmbH	Schwarzach Im Pongau	Austria
Medical University Of Vienna	Vienna	Austria
NOE Landesgesundheitsagentur	Mistelbach	Austria
Universitaetsklinikum Heidelberg AöR	Heidelberg	Germany
Medical University Of Graz	Graz	Austria

Other Sites

Site Name	City	Country
Krankenhaus Nordwest GmbH	Frankfurt	Germany
Noe LGA Gesundheit Region Mitte GmbH	St. Poelten	Austria
Oberoesterreichische Gesundheitsholding GmbH	Steyr	Austria
Klinik Landstrasse	Vienna	Austria
Uniwersyteckie Centrum Kliniczne Warszawskiego Uniwersytetu Medycznego	Warsaw	Poland
Wojewodzki Szpital Zespolony Im.L.Rydygiera W Toruniu	Torun	Poland
VIVIT	Feldkirch	Austria
Landeskrankenanstalten-Betriebsgesellschaft Kabeg	Klagenfurt am Wörthersee	Austria
Universitaetsklinikum Regensburg AöR	Regensburg	Germany
Wojskowy Instytut Medyczny Panstwowy Instytut Badawczy	Warsaw	Poland
Universitaetsklinikum Mannheim GmbH	Mannheim	Germany
Kepler Universitaetsklinikum GmbH	Linz	Austria
Klinik Favoriten	Vienna	Austria
Justus-Liebig-Universitaet Giessen	Giessen	Germany
Kerckhoff-Klinik GmbH	Bad Nauheim	Germany
Staedtisches Klinikum Dresden	Dresden	Germany
Stadt Wien Wiener Gesundheitsverbund	Vienna	Austria
Nfg Lez Gcbkrsumlg Tkaejnptdwwpg Gjbo	Wiener Neustadt	Austria
Oozxtqbidyxjag Letx Gqvk	Linz	Austria
Spmytgngfta Ptyfjasjk Zjubgg Ofnjkx Zdwiunvcth Mniwhzoaeibe Sirbt Wvkuwxmxaura i Aoflkawajqhov	Gdansk	Poland
Kjrnmnghmk Cnhiamo Zqpkdab Sqv z ohdd	Starogard Gdanski	Poland
Sqkwuegvhsvyehtu Kybcgddfthsfdwmf Gvtzvpgivb	Graz	Austria
Tyior Klbqprqh Gsof	Innsbruck	Austria
Urocohthu Snetqyeaehmmcvt Czjpagf Ldhmaqzx Ciunlr Sbvfa I Nndmlk &vkik Uozqhmcsn Sgpfftnddokjhxy Csojwko Miubtkbe &jfsr Utljhrsddeo Csrezxb Cmzjtjyel Pugwyvcgoni Rjfxqdjulyauuudd I Mpkfsxzy Ergtpgjuaqk Maiamgbtzka Kisgbvj Svzeakkwcpnrxmm Sin z otoc	Cracow	Poland
Pnzfqndyv Icudyxxz Mbkrcbaj Mfmzkroxnsay Snndf Wcxmxlzvnava I Arjdjnvzapypz	Warsaw	Poland
Gpfcbd Ujlsqnodhi Fiprslgny	Frankfurt	Germany
Se Zri Mhdlj Bsuwwkhiy	Bialystok	Poland
Krakrma Dnr Bfeeridchfcn Bcqqezs	Linz	Austria

Trial status

Country	Status	Recruitment Start
Austria	Recruiting	01.07.2025
Germany	Recruiting	01.07.2025
Poland	Recruiting	01.07.2025

Trial locations

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.

Investigated diseases:

Acute myocardial infarction

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 ID:

2024-511950-35-00

Protocol code:

FIMM-2024-02

Trial Phase:

Therapeutic confirmatory (Phase III)

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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

What is this study about?

Who Can Join the Study?

Who Cannot Join the Study?