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

February 2, 2026 updated by: Boehringer Ingelheim

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

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.

Study Overview

Status

Terminated

Conditions

Intervention / Treatment

Study Type

Interventional

Enrollment (Actual)

160

Phase

  • Phase 2

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Locations

  • Australia
    • New South Wales
      • Liverpool, New South Wales, Australia, 2170
        • South Western Sydney Local Health District
    • Victoria
      • Epping, Victoria, Australia, 3076
        • The Northern Hospital
  • Canada
      • Québec, Canada, G1V 4G5
        • Institut Universitaire De Cardiologie Et De Pneumologie De Québec
    • Ontario
      • Hamilton, Ontario, Canada, L8L 2X2
        • Hamilton General Hospital
      • Ottawa, Ontario, Canada, K1Y 4W7
        • University of Ottawa Heart Institute
    • Quebec
      • Montreal, Quebec, Canada, H2X 0C1
        • Centre Hospitalier de l'Universite de Montreal (CHUM)
  • Czechia
      • Brno, Czechia, 62500
        • University Hospital Brno
      • Brno, Czechia, 602 00
        • St. Anna Hospital
      • Prague, Czechia, 128 00
        • General University Hospital
  • Germany
      • Berlin, Germany, 13353
        • Charité - Universitätsmedizin Berlin
      • Dresden, Germany, 01067
        • Stadtisches Klinikum Dresden
      • Frankfurt, Germany, 60590
        • Universitätsklinikum Frankfurt
      • Freiburg im Breisgau, Germany, 79106
        • Universitatsklinikum Freiburg
      • Hanover, Germany, 30625
        • Medizinische Hochschule Hannover
      • Langen, Germany, 63225
        • Asklepios Klinik Langen-Seligenstadt GmbH
      • Leipzig, Germany, 04103
        • Universität Leipzig
      • Leipzig, Germany, 04289
        • Helios Herzzentrum Leipzig GmbH
      • Ludwigshafen, Germany, 67063
        • Klinikum der Stadt Ludwigshafen am Rhein GmbH
      • Ulm, Germany, 89081
        • Universitatsklinikum Ulm
  • Hungary
      • Budapest, Hungary, 1122
        • Semmelweis University
      • Pécs, Hungary, 7624
        • University of Pecs
      • Zalaegerszeg, Hungary, 8900
        • Zala County Hospital, Zalaegerszeg
  • Italy
      • Bari, Italy, 70124
        • Ospedale San Paolo-Bari-18924
      • Catania, Italy, 95126
        • Azienda Ospedaliera Cannizzaro
      • Cona (FE), Italy, 44124
        • Azienda Ospedaliera Universitaria Arcispedale Sant'Anna
      • Massa, Italy, 54100
        • Osp. Pediatrico Apuano Pasquinucci
      • Monza, Italy, 20900
        • A.O. San Gerardo di Monza
      • Torino, Italy, 10128
        • Ospedale Mauriziano di Torino
  • New Zealand
      • Grafton / Auckland, New Zealand, 1023
        • Auckland City Hospital
  • Poland
      • Chrzanów, Poland, 32-500
        • American-Polish Heart Clinic, Lesser Poland Cardiovascular Centre
      • Krakow, Poland, 30-688
        • University Hospital in Krakow
      • Myszków, Poland, 42 300
        • Independent Public Health Care in Myszkow
      • Opole, Poland, 45-401
        • University Clinical Hospital in Opole
      • Rzeszów, Poland, 35-111
        • Independent Public Health Care Center of the Ministry of the Interior in Rzeszow
      • Tychy, Poland, 43-100
        • American Heart of Poland Sp. z o.o.-Tychy-44644
  • Singapore
      • Singapore, Singapore, 544886
        • Sengkang General Hospital
      • Singapore, Singapore, 169609
        • National Heart Centre Singapore
      • Singapore, Singapore, 119074
        • National University Hospital-Singapore-42005
  • Slovakia
      • Banská Bystrica, Slovakia, 97401
        • Cardiovascular Diseases institute of Central Slovakia
      • Bratislava, Slovakia, 831 01
        • National Institute of Cardiovascular Diseases
      • Nitra, Slovakia, 949 01
        • Cardiocenter Nitra, s.r.o
  • South Korea
      • Seoul, South Korea, 04763
        • Hanyang University Medical Center
  • Spain
      • Barcelona, Spain, 08026
        • Hospital Santa Creu i Sant Pau
      • Barcelona, Spain, 08035
        • Hospital Universitari Vall D Hebron
      • Madrid, Spain, 28046
        • Hospital Universitario La Paz
      • Madrid, Spain, 28009
        • Hospital General Universitario Gregorio Marañon
      • Seville, Spain, 41009
        • Hospital Universitario Virgen de la Macarena
      • Vigo, Spain, 36312
        • Complejo Hospitalario Universitario de Vigo
  • Taiwan
      • Tainan, Taiwan, 704
        • NCKUH
      • Taipei, Taiwan, 100
        • National Taiwan University Hospital
  • United Kingdom
      • Clydebank, United Kingdom, G81 4DY
        • Golden Jubilee National Hospital
      • Leeds, United Kingdom, LS1 3EX
        • Leeds General Infirmary
      • Newcastle upon Tyne, United Kingdom, NE7 7DN
        • Freeman Hospital

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

  • Adult
  • Older Adult

Accepts Healthy Volunteers

No

Description

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.

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

  • Primary Purpose: Treatment
  • Allocation: Randomized
  • Interventional Model: Parallel Assignment
  • Masking: Triple

Arms and Interventions

Participant Group / Arm
Intervention / Treatment
Placebo Comparator: Placebo group
Drug: Placebo matching BI 765845
Placebo matching BI 765845
Experimental: BI 765845 very low dose group, administration type 1
Drug: BI 765845
BI 765845
Experimental: BI 765845 low dose group, administration type 1
Drug: BI 765845
BI 765845
Experimental: BI 765845 medium dose group, administration type 1
Drug: BI 765845
BI 765845
Experimental: BI 765845 high dose group, administration type 1
Drug: BI 765845
BI 765845
Experimental: BI 765845 low dose group, administration type 2
Drug: BI 765845
BI 765845
Experimental: BI 765845 high dose group, administration type 2
Drug: BI 765845
BI 765845

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Time Frame
Infarct size measured as the percentage of left ventricular mass that is infarcted as detected using late gadolinium enhancement (LGE) by cardiac magnetic resonance (CMR)
Time Frame: At Day 5
At Day 5

Secondary Outcome Measures

Outcome Measure
Time Frame
Infarct size measured as the percentage of left ventricular mass that is infarcted as detected using Late gadolinium enhancement (LGE) by cardiac magnetic resonance (CMR)
Time Frame: At Day 90
At Day 90
Difference in myocardial Infarct size (IS)
Time Frame: At Day 5 and Day 90
At Day 5 and Day 90

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

Boehringer Ingelheim

Publications and helpful links

The person responsible for entering information about the study voluntarily provides these publications. These may be about anything related to the study.

Helpful Links

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start (Actual)

December 5, 2023

Primary Completion (Actual)

September 2, 2025

Study Completion (Actual)

December 2, 2025

Study Registration Dates

First Submitted

November 7, 2023

First Submitted That Met QC Criteria

November 15, 2023

First Posted (Actual)

November 18, 2023

Study Record Updates

Last Update Posted (Actual)

February 4, 2026

Last Update Submitted That Met QC Criteria

February 2, 2026

Last Verified

February 1, 2026

More Information

Terms related to this study

Additional Relevant MeSH Terms

Other Study ID Numbers

  • 1478-0002
  • U1111-1291-6320 (Other Identifier: WHO/UTN)
  • 2022-502788-39-00 (Other Identifier: CTIS)

Plan for Individual participant data (IPD)

Plan to Share Individual Participant Data (IPD)?

YES

IPD Plan Description

Once the criteria in section "Time Frame" are fulfilled, researchers can use the following link https://www.clinicalstudies.boehringer-ingelheim.com/msw/datasharing to request access to the clinical study documents regarding this study, and upon a signed "Document Sharing Agreement".

Furthermore, researchers can request access to the clinical study data, for this and other listed studies, after the submission of a research proposal and according to the terms outlined in the website.

IPD Sharing Time Frame

One year after the approval has been granted by major regulatory authorities and after the primary manuscript has been accepted for publication, or after termination of the development program.

IPD Sharing Access Criteria

For study documents - upon signing of a 'Document Sharing Agreement'.

For study data - 1. after the submission and approval of the research proposal (checks will be performed by the sponsor and/or the independent review panel, including checking that the planned analysis does not compete with sponsor's publication plan); 2. and upon signing of a legal agreement.

IPD Sharing Supporting Information Type

  • STUDY_PROTOCOL
  • SAP
  • CSR

Drug and device information, study documents

Studies a U.S. FDA-regulated drug product

Yes

Studies a U.S. FDA-regulated device product

No

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

Clinical Trials on Myocardial Infarction

Clinical Trials on BI 765845

Search Similar Trials

Sponsors and Collaborators

Medical Conditions

Drug Interventions

CROs by country

CROs in Serbia

Conditions

Rare Diseases

Drug Interventions

Dietary Supplements

Sponsor/Collaborators

Locations

Subscribe