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NCT06139328

PHASE2

IRI-EXPLORE: A Study to Test Whether BI 765845 Helps People Who Have Had a Heart Attack

Sponsor: Boehringer Ingelheim

View on ClinicalTrials.gov

Summary

This study is open to adults aged 18 and over who have just had a heart attack. The purpose of this study is to find out whether a medicine called BI 765845 helps people who have had a heart attack. The investigators also want to test how well different doses of BI 765845 work and how they are tolerated by people who have had a heart attack. Participants are randomly assigned to receive either BI 765845 or placebo. Placebo treatments look like BI 765845 treatments but do not contain any medicine. Participants are about 3 times as likely to receive BI 765845 than placebo. Participants are in the study for 3 months. During this time, they visit the study site 7 times and get 3 phone calls from the site staff. At the visits, the doctors use clinical tests to check the health of the heart. The results are compared between the BI 765845 and placebo groups to see whether the treatment works. The doctors also regularly check participants' health and take note of any unwanted effects.

Official title: Randomised Study for Double-blind, Placebo-controlled Evaluation of a Single Intravenous Infusion of BI 765845 and Partially-blinded Evaluation of a Single Bolus Administration of BI 765845 on Top of Standard of Care in Patients With Acute Myocardial Infarction

Key Details

Gender

All

Age Range

18 Years - Any

Study Type

INTERVENTIONAL

Enrollment

160

Start Date

2023-12-05

Completion Date

2025-12-02

Last Updated

2026-06-24

Healthy Volunteers

Conditions

Myocardial Infarction

Interventions

DRUG

BI 765845

DRUG

Placebo matching BI 765845

Inclusion Criteria: 1. Age ≥18 years (or legal age as per local regulations) at the time of signing informed consent 2. Signed and dated written informed consent in accordance with ICH Good Clinical Practice (GCP) and local legislation prior to admission to the trial. 3. Male or female participants of non-childbearing potential. Male participants must be ready and able to use highly effective methods of birth control per ICH M3 (R2) for at least 5 days following investigational medicinl product (IMP) administration. Women who are not of childbearing potential are considered those that fulfil at least one or more of the following: aged 50 years or above and being naturally amenorrhoeic for at least 1 year (amenorrhoea following cancer therapy or during breast-feeding does not rule out childbearing potential) OR have premature ovarian failure confirmed by a gynaecologist OR have undergone bilateral salpingo-oophorectomy OR have undergone hysterectomy OR are affected by Turner syndrome OR have uterine agenesis 4. Onset of symptoms of myocardial ischaemia or myocardial infarct, according to patient report, within a duration of: Part A: ≥1 hour (h) and ≤12 h prior to randomisation Part B: ≥1 h and ≤12 h prior to randomisation Further inclusion criteria apply. Exclusion Criteria: 1. Women of childbearing potential 2. Patients indicated for rescue PCI (i.e. after receiving fibrinolysis) 3. Patients presenting with cardiogenic shock defined as either systolic blood pressure (SBP) ≤90 mmHg persisting despite fluid challenge or inotropes/vasopressors use to maintain SBP \>90 mmHg. 4. Known history of symptomatic heart failure (HF) with left ventricular systolic dysfunction (i.e. HFrEF) based on verbal medical history as reported by a trial participant or authorised representative 5. Known history of myocardial infarction (MI) with the exception of the index event (based on verbal medical history as reported by a trial participant or authorised representative) 6. Previous coronary artery bypass grafting (CABG) (based on verbal medical history as reported by a trial participant or authorised representative) Further exclusion criteria apply.

Locations (53)

South Western Sydney Local Health District

Liverpool, New South Wales, Australia

The Northern Hospital

Epping, Victoria, Australia

Hamilton General Hospital

Hamilton, Ontario, Canada

University of Ottawa Heart Institute

Ottawa, Ontario, Canada

Centre Hospitalier de l'Universite de Montreal (CHUM)

Montreal, Quebec, Canada

Institut Universitaire de Cardiologie et de Pneumologie de Quebec (IUCPQ)

Québec, Canada

St. Anna Hospital

Brno, Czechia

University Hospital Brno

Brno, Czechia

General University Hospital

Prague, Czechia

Charité - Universitätsmedizin Berlin

Berlin, Germany

Städtisches Klinikum Dresden

Dresden, Germany

Universitätsklinikum Frankfurt

Frankfurt, Germany

Universitätsklinikum Freiburg

Freiburg im Breisgau, Germany

Medizinische Hochschule Hannover

Hanover, Germany

Asklepios Klinik Langen-Seligenstadt GmbH

Langen, Germany

Universität Leipzig

Leipzig, Germany

Helios Herzzentrum Leipzig GmbH

Leipzig, Germany

Klinikum der Stadt Ludwigshafen am Rhein GmbH

Ludwigshafen, Germany

Universitätsklinikum Ulm

Ulm, Germany

Semmelweis University

Budapest, Hungary

University of Pecs

Pécs, Hungary

Zala County Hospital, Zalaegerszeg

Zalaegerszeg, Hungary

Ospedale San Paolo-Bari-18924

Bari, Italy

Azienda Ospedaliera Cannizzaro

Catania, Italy

Azienda Ospedaliera Universitaria Arcispedale Sant'Anna

Cona (FE), Italy

Osp. Pediatrico Apuano Pasquinucci

Massa, Italy

A.O. San Gerardo di Monza

Monza, Italy

Ospedale Mauriziano di Torino

Torino, Italy

Auckland City Hospital

Grafton / Auckland, New Zealand

American-Polish Heart Clinic, Lesser Poland Cardiovascular Centre

Chrzanów, Poland

University Hospital in Krakow

Krakow, Poland

Independent Public Health Care in Myszkow

Myszków, Poland

University Clinical Hospital in Opole

Opole, Poland

Independent Public Health Care Center of the Ministry of the Interior in Rzeszow

Rzeszów, Poland

American Heart of Poland Sp. z o.o.-Tychy-44644

Tychy, Poland

National University Hospital-Singapore-42005

Singapore, Singapore

National Heart Centre Singapore

Singapore, Singapore

Sengkang General Hospital

Singapore, Singapore

Cardiovascular Diseases institute of Central Slovakia

Banská Bystrica, Slovakia

National Institute of Cardiovascular Diseases

Bratislava, Slovakia

Cardiocenter Nitra, s.r.o

Nitra, Slovakia

Hanyang University Medical Center

Seoul, South Korea

Hospital Santa Creu i Sant Pau

Barcelona, Spain

Hospital Universitari Vall d'Hebron

Barcelona, Spain

Hospital General Universitario Gregorio Marañón

Madrid, Spain

Hospital Universitario La Paz

Madrid, Spain

Hospital Universitario Virgen De La Macarena

Seville, Spain

Complejo Hospitalario Universitario de Vigo

Vigo, Spain

NCKUH

Tainan, Taiwan

National Taiwan University Hospital

Taipei, Taiwan

Golden Jubilee National Hospital

Clydebank, United Kingdom

Leeds General Infirmary

Leeds, United Kingdom

Freeman Hospital

Newcastle upon Tyne, United Kingdom

Clinical Research Directory

IRI-EXPLORE: A Study to Test Whether BI 765845 Helps People Who Have Had a Heart Attack

Summary

Key Details

Conditions

Interventions

Eligibility Criteria

Locations (53)