Clinical trial • Cardiology

Icosapent ethyl for Acute myocardial infarction

Clinical trial of Icosapent ethyl for Acute myocardial infarction.

Overview

Trial Therapeutic Area
Cardiology
Trial Disease
Acute myocardial infarction
Drug Modality
Small molecule

Key dates

Initial CTIS Submission Date
22-01-2025
First CTIS Authorization Date
14-05-2025

Trial design

Randomised, standard guideline treatment (control) versus intensified residual risk management (intervention); no specific comparator drug, dose or schedule stated in the ctis record. trial in Germany, Poland, Austria.

Randomised
Yes
Comparator
Standard guideline treatment (control) versus intensified residual risk management (intervention); no specific comparator drug, dose or schedule stated in the CTIS record.
Target Sample Size
1758
Trial Duration For Participant
234

Eligibility

Recruits 1758 No vulnerable population selected. Participants are adults (>18 years). Written informed consent from the participant is required; no assent procedures for minors are applicable..

Pregnancy Exclusion
Women who are pregnant or breast-feeding
Vulnerable Population
No vulnerable population selected. Participants are adults (>18 years). Written informed consent from the participant is required; no assent procedures for minors are applicable.

Inclusion criteria

  • {"criterion_text":"- Individuals > 18 years of age\n- Written consent of the participant after being informed\n- Percutaneous coronary intervention (PCI) procedure for acute myocardial infarction (inclusion window: 48 hours to 14 days after PCI)\n- BIO-RISK-EVENT score parameters available"}

Exclusion criteria

  • {"criterion_text":"- Previous myocardial infarction (prior to the current event leading to enrolment)\n- Known drug or alcohol abuse or psychiatric disorder that, in the opinion of the investigator prevents participation from following the protocol\n- Haemodynamic instability as defined by intravenous administration of catecholamines, calcium sensitisers or phosphodiesterase inhibitors\n- New York Heart Failure (NYHA) Functional Classification Class IV heart failure at baseline\n- Participation in another clinical trial that may affect the results of this study\n- Type 1 diabetes mellitus\n- eGFR <45 mL/min/1.73 m2\n- Liver cirrhosis Childs B or C or other known liver disease preventing the study candidate to participate according to the judgment of the investigator\n- Women who are pregnant or breast-feeding\n- Women of child-bearing potential\n- Treatment with ciclosporin and strong CYP3A3 inhibitors\n- Current treatment with an SGLT2 inhibitor\n- Have family (first-degree-relative) or personal history of medullary thyroid carcinoma or multiple endocrine neoplasia syndrome type 2\n- Have had a transplanted organ or awaiting an organ transplant\n- Men whose partners are capable of becoming pregnant may only participate in the clinical study if they commit to using a reliable method of contraception throughout the study duration and for at least 6 months after the end of the trial medication\n- Current treatment with colchicine\n- Current treatment with icosapent ethyl\n- Known allergy to any of the medications being used for intensified treatment or their constituents, or to medications with a similar chemical structure\n- Active known malignancies within the last year, except intraepithelial neoplasm of the prostate, gastrointestinal tract and basal cell carcinoma\n- Known history of retinopathy and/or macular oedema\n- Acute inflammatory disease (e.g. pneumonia, urinary tract infection, etc.)\n- Chronic inflammatory disease (e.g. inflammatory bowel disease, rheumatoid arthritis, etc.)"}

Endpoints

Primary endpoints

  • {"endpoint_text":"- Time to first event of a composite of cardiovascular outcomes encompassing - Cardiovascular death - Non-fatal myocardial infarction -Non-fatal stroke - Hospitalisation for urgent coronary revascularisation - Hospitalisation for heart failure","definition_or_measurement_approach":"Measured as time-to-event: time from baseline/randomisation to the first occurrence of any of the listed composite cardiovascular outcomes."}

Secondary endpoints

  • {"endpoint_text":"- Time to first event for cardiovascular death\n- Time to all-cause mortality\n- Time to first event for non-fatal myocardial infarction\n- Time to first event for non-fatal stroke\n- Time to first event for hospitalisation for urgent coronary revascularisation\n- Time to first event for hospitalisation for heart failure\n- Time to first event of a composite of cardiovascular outcomes encompassing -Cardiovascular death -Non-fatal myocardial infarction -Non-fatal stroke\n- Time to first event of a composite of cardiovascular outcomes encompassing -Cardiovascular death -Hospitalisation for heart failure\n- Time to first event for any urgent revascularisation procedure of a -Coronary artery -Carotid artery -Peripheral artery\n- Time to first event for major adverse limb events","definition_or_measurement_approach":"All secondary endpoints are time-to-event measures (time from baseline/randomisation to first occurrence of the specified event or composite)."}

Recruitment

Planned Sample Size
1758
Recruitment Window Months
36
Consent Approach
Written informed consent required from the participant after being informed. Participants are adults (>18 years). Country-specific subject information and informed consent forms are provided (documents available for Austria, Germany and Poland).

Geography

Total Number Of Sites
35
Total Number Of Participants
1758

Germany

Earliest CTIS Part Ii Submission Date
14-04-2025
Latest Decision Or Authorization Date
13-02-2026
Processing Time Days
305
Number Of Sites
8
Number Of Participants
558

Sites

Site Name
Universitaetsklinikum Mannheim GmbH
Department Name
1st Medical Department (Cardiology, Angiology, Hemostaseology and Internal Intensive Medicine)
Contact Person Name
Harald Langer
Contact Person Email
harald.langer@umm.de
Site Name
Universitaetsklinikum Heidelberg AöR
Department Name
Department for Cardiology, Angiology and Pneumology
Contact Person Name
Manuela Licka
Site Name
Universitaetsklinikum Frankfurt AöR
Department Name
Department of Internal Medicine 3, Cardiology and Angiology
Contact Person Name
David Leistner
Site Name
Staedtisches Klinikum Dresden
Department Name
2nd Medical Department
Contact Person Name
Frank Heinzel
Site Name
Universitaetsklinikum Regensburg AöR
Department Name
Internal Medicine II, Cardiology, Pneumology, Internal Intensive Medicine
Contact Person Name
Christian Schach
Contact Person Email
christian.schach@ukr.de
Site Name
Justus-Liebig-Universitaet Giessen
Department Name
1st Medical Department, Cardiology and Angiology
Contact Person Name
Samuel Tobias Sossalla
Site Name
Krankenhaus Nordwest GmbH
Department Name
Clinic for Pulmonology, Respiratory and Intensive Care Medicine, Gastroenterology, Cardiology
Contact Person Name
Roland Klingenberg
Contact Person Email
klingenberg.roland@khnw.de
Site Name
Kerckhoff-Klinik GmbH
Department Name
Division of Cardiology
Contact Person Name
Samuel Tobias Sossalla

Poland

Earliest CTIS Part Ii Submission Date
24-04-2025
Latest Decision Or Authorization Date
16-02-2026
Processing Time Days
298
Number Of Sites
8
Number Of Participants
600

Sites

Site Name
Panstwowy Instytut Medyczny Ministerstwa Spraw Wewnetrznych I Administracji
Department Name
Department of Cardiology
Contact Person Name
Robert Gil
Contact Person Email
kardiologia@cskmswia.gov.pl
Site Name
Wojewodzki Szpital Zespolony Im.L.Rydygiera W Toruniu
Department Name
Clinical Department of Cardiology and Intensive Cardiac Therapy
Contact Person Name
Grzegorz Skonieczny
Contact Person Email
grzegorz.skonieczny@onet.eu
Site Name
Samodzielny Publiczny Zakład Opieki Zdrowotnej Ministerstwa Spraw Wewnętrznych i Administracji
Department Name
Department of Cardiology
Contact Person Name
Edyta Pieta
Contact Person Email
kardiologia@zozmswia.gda.pl
Site Name
Kociewskie Centrum Zdrowia Sp. z o.o.
Department Name
Department of Cardiology
Contact Person Name
MArek Kozinski
Contact Person Email
marekkozinski@wp.pl
Site Name
Wojskowy Instytut Medyczny Panstwowy Instytut Badawczy
Department Name
Department of Interventional Cardiology and Internal Medicine
Contact Person Name
Sławomir Gołębiewski
Contact Person Email
sgolebiewski@wim.mil.pl
Site Name
Ministerstwa Spraw Wewnetrznych I Administracji W Bialymstoku Im. Mariana Zyndrama-Koscialkowskiego Samodzielny Publiczny Zaklad Opieki Zdrowotnej
Department Name
Department of Cardiology
Contact Person Name
Rafał Skręta
Contact Person Email
rafal.skreta@gmail.com
Site Name
Unicardia Specjalistyczne Centrum Leczenia Chorob Serca I Naczyn & Unimedica Specjalistyczne Centrum Medyczne & Uniestetica Centrum Chirurgii Plastycznej Rekonstrukcyjnej I Medycyny Estetycznej Malopolskie Kliniki Specjalistyczne Sp. z o.o.
Department Name
Unicardia Specialist Center for the Treatment of Heart Diseases
Contact Person Name
Grzegorz Gajos
Contact Person Email
prof.grzegorz.gajos@gmail.com
Site Name
Uniwersyteckie Centrum Kliniczne Warszawskiego Uniwersytetu Medycznego
Department Name
1st Department and Clinic of Cardiology
Contact Person Name
Aleksandra Gąsecka-van der Pol
Contact Person Email
aleksandra.gasecka@wum.edu.pl

Austria

Earliest CTIS Part Ii Submission Date
14-04-2025
Latest Decision Or Authorization Date
16-02-2026
Processing Time Days
308
Number Of Sites
19
Number Of Participants
600

Sites

Site Name
Medical University Of Graz
Department Name
Department of Internal Medicine, Division of Cardiology
Contact Person Name
Heiko Bugger
Contact Person Email
heiko.bugger@medunigraz.at
Site Name
Klinik Landstrabe
Department Name
2nd Medical Department with cardiology and internal intensive care medicine
Contact Person Name
Alexander Niessner
Site Name
Kepler Universitaetsklinikum GmbH
Department Name
Department of Cardiology and Intensive Care Medicine
Contact Person Name
Clemens Steinwender
Site Name
Landeskrankenanstalten-Betriebsgesellschaft Kabeg
Department Name
Department for Internal Medicine and Cardiology
Contact Person Name
Hannes Alber
Contact Person Email
hannes.alber@kabeg.at
Site Name
Klinik Favoriten
Department Name
5th Medical Department Divison of Cardiology
Contact Person Name
Diana Bondermann
Site Name
Noe LGA Gesundheit Region Mitte GmbH
Department Name
Department of Internal Medicine 3
Contact Person Name
Deddo Mörtl
Site Name
Steiermaerkische Krankenanstalten Ges.m.b.H.
Department Name
Department of Cardiology and Intensive Care Medicine
Contact Person Name
Herwig Schuchlenz
Contact Person Email
herwig.schuchlenz@kages.at
Site Name
Noe LGA Gesundheit Thermenregion GmbH
Department Name
Department of Internal Medicine, Cardiology and Nephrology
Contact Person Name
Maximilian Tscharre
Site Name
Medical University Of Vienna
Department Name
Department of Internal Medicine III Division of Cardiology
Contact Person Name
Jolanta Siller-Matula
Site Name
Stadt Wien Wiener Gesundheitsverbund
Department Name
3rd medical department with cardiology, internal medicine intensive care, and outpatient clinic
Contact Person Name
David Zweiker
Site Name
Ordensklinikum Linz GmbH
Department Name
Internal Medicine 2 – Cardiology, Angiology and Internal Intensive Care Medicine
Contact Person Name
Martin Martinek
Site Name
Vivit Institute
Department Name
Department of Internal Medicine
Contact Person Name
Matthias Frick
Contact Person Email
matthias.frick@lkhf.at
Site Name
Oberoesterreichische Gesundheitsholding GmbH
Department Name
Department of Cardiology, Nephrology and Internal Intensive Care Medicine
Contact Person Name
Lukas Motloch
Contact Person Email
lukas.motloch@ooeg.at
Site Name
Oberoesterreichische Gesundheitsholding GmbH
Department Name
Department of Internal Medicine 1
Contact Person Name
Johannes Siebermair
Contact Person Email
johannes.siebermair@ooeg.at
Site Name
NOE Landesgesundheitsagentur
Department Name
Department of Cardiology and Internal Intensive Care Medicine
Contact Person Name
Thomas Gremmel
Site Name
Kardinal Schwarzenberg Klinikum GmbH
Department Name
Department of Internal Medicine 1
Contact Person Name
Anna Rab
Contact Person Email
anna.rab@ks-klinikum.at
Site Name
Konvent Der Barmherzigen Brueder
Department Name
Department of Internal Medicine
Contact Person Name
Martin Clodi
Contact Person Email
martin.clodi@bblinz.at
Site Name
Tirol Kliniken GmbH
Department Name
Department of Internal Medicine III Division of Cardiology and Angiology
Contact Person Name
Sebastian Reinstadler
Site Name
Bezirkskrankenhaus St. Johann
Department Name
Department of Internal Medicine
Contact Person Name
Peter Rainer
Contact Person Email
peter.rainer@khsj.at

Sponsor

Primary sponsor

Full Name
Medical University Of Graz
Organisation Type
Educational Institution
Country Of Registered Address
Austria

Third parties

  • {"country":"","full_name":"European Union","duties_or_roles":"Monetary support","organisation_type":""}

Investigational products

Investigational Product Name
Vazkepa 998 mg soft capsules
Active Substance
Icosapent ethyl
Modality
Small molecule
Routes Of Administration
Oral
Route
Oral
Authorisation Status
Authorised
Maximum Dose
4 g
Investigational Product Name
EMPAGLIFLOZIN
Active Substance
Empagliflozin
Modality
Small molecule
Routes Of Administration
Oral
Route
Oral
Authorisation Status
Authorised
Maximum Dose
10 mg
Investigational Product Name
COLCHICINE
Active Substance
Colchicine
Modality
Small molecule
Routes Of Administration
Oral
Route
Oral
Authorisation Status
Authorised
Maximum Dose
0.5 mg

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