Study Stopped
Sponsor decision
IRI-EXPLORE: A Study to Test Whether BI 765845 Helps People Who Have Had a Heart Attack
IRI-EXPLORE
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
3 other identifiers
interventional
160
14 countries
53
Brief 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.
Trial Health
Trial Health Score
Automated assessment based on enrollment pace, timeline, and geographic reach
participants targeted
Target at P75+ for phase_2
Started Dec 2023
53 active sites
Health score is calculated from publicly available data and should be used for screening purposes only.
Trial Relationships
Click on a node to explore related trials.
Study Timeline
Key milestones and dates
First Submitted
Initial submission to the registry
November 7, 2023
CompletedFirst Posted
Study publicly available on registry
November 18, 2023
CompletedStudy Start
First participant enrolled
December 5, 2023
CompletedPrimary Completion
Last participant's last visit for primary outcome
September 2, 2025
CompletedStudy Completion
Last participant's last visit for all outcomes
December 2, 2025
CompletedFebruary 4, 2026
February 1, 2026
1.7 years
November 7, 2023
February 2, 2026
Conditions
Outcome Measures
Primary Outcomes (1)
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)
At Day 5
Secondary Outcomes (2)
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)
At Day 90
Difference in myocardial Infarct size (IS)
At Day 5 and Day 90
Study Arms (7)
BI 765845 very low dose group, administration type 1
EXPERIMENTALBI 765845 low dose group, administration type 1
EXPERIMENTALBI 765845 medium dose group, administration type 1
EXPERIMENTALBI 765845 high dose group, administration type 1
EXPERIMENTALPlacebo group
PLACEBO COMPARATORBI 765845 low dose group, administration type 2
EXPERIMENTALBI 765845 high dose group, administration type 2
EXPERIMENTALInterventions
BI 765845
Eligibility Criteria
You may qualify if:
- Age ≥18 years (or legal age as per local regulations) at the time of signing informed consent
- Signed and dated written informed consent in accordance with ICH Good Clinical Practice (GCP) and local legislation prior to admission to the trial.
- 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
- Onset of symptoms of myocardial ischaemia or myocardial infarct, according to patient report, within a duration of:
You may not qualify if:
- Women of childbearing potential
- Patients indicated for rescue PCI (i.e. after receiving fibrinolysis)
- 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.
- 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
- 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)
Contact the study team to confirm eligibility.
Sponsors & Collaborators
Study Sites (53)
South Western Sydney Local Health District
Liverpool, New South Wales, 2170, Australia
The Northern Hospital
Epping, Victoria, 3076, Australia
Hamilton General Hospital
Hamilton, Ontario, L8L 2X2, Canada
University of Ottawa Heart Institute
Ottawa, Ontario, K1Y 4W7, Canada
Centre Hospitalier de l'Universite de Montreal (CHUM)
Montreal, Quebec, H2X 0C1, Canada
Institut Universitaire de Cardiologie et de Pneumologie de Quebec
Québec, G1V 4G5, Canada
St. Anna Hospital
Brno, 602 00, Czechia
University Hospital Brno
Brno, 62500, Czechia
General University Hospital
Prague, 128 00, Czechia
Charité - Universitätsmedizin Berlin
Berlin, 13353, Germany
Städtisches Klinikum Dresden
Dresden, 01067, Germany
Universitätsklinikum Frankfurt
Frankfurt, 60590, Germany
Universitätsklinikum Freiburg
Freiburg im Breisgau, 79106, Germany
Medizinische Hochschule Hannover
Hanover, 30625, Germany
Asklepios Klinik Langen-Seligenstadt GmbH
Langen, 63225, Germany
Universität Leipzig
Leipzig, 04103, Germany
Helios Herzzentrum Leipzig GmbH
Leipzig, 04289, Germany
Klinikum der Stadt Ludwigshafen am Rhein GmbH
Ludwigshafen, 67063, Germany
Universitätsklinikum Ulm
Ulm, 89081, Germany
Semmelweis University
Budapest, 1122, Hungary
University of Pecs
Pécs, 7624, Hungary
Zala County Hospital, Zalaegerszeg
Zalaegerszeg, 8900, Hungary
Ospedale San Paolo-Bari-18924
Bari, 70124, Italy
Azienda Ospedaliera Cannizzaro
Catania, 95126, Italy
Azienda Ospedaliera Universitaria Arcispedale Sant'Anna
Cona (FE), 44124, Italy
Osp. Pediatrico Apuano Pasquinucci
Massa, 54100, Italy
A.O. San Gerardo di Monza
Monza, 20900, Italy
Ospedale Mauriziano di Torino
Torino, 10128, Italy
Auckland City Hospital
Grafton / Auckland, 1023, New Zealand
American-Polish Heart Clinic, Lesser Poland Cardiovascular Centre
Chrzanów, 32-500, Poland
University Hospital in Krakow
Krakow, 30-688, Poland
Independent Public Health Care in Myszkow
Myszków, 42 300, Poland
University Clinical Hospital in Opole
Opole, 45-401, Poland
Independent Public Health Care Center of the Ministry of the Interior in Rzeszow
Rzeszów, 35-111, Poland
American Heart of Poland Sp. z o.o.-Tychy-44644
Tychy, 43-100, Poland
National University Hospital-Singapore-42005
Singapore, 119074, Singapore
National Heart Centre Singapore
Singapore, 169609, Singapore
Sengkang General Hospital
Singapore, 544886, Singapore
Cardiovascular Diseases institute of Central Slovakia
Banská Bystrica, 97401, Slovakia
National Institute of Cardiovascular Diseases
Bratislava, 831 01, Slovakia
Cardiocenter Nitra, s.r.o
Nitra, 949 01, Slovakia
Hanyang University Medical Center
Seoul, 04763, South Korea
Hospital Santa Creu i Sant Pau
Barcelona, 08026, Spain
Hospital Universitari Vall D Hebron
Barcelona, 08035, Spain
Hospital General Universitario Gregorio Marañón
Madrid, 28009, Spain
Hospital Universitario La Paz
Madrid, 28046, Spain
Hospital Universitario Virgen De La Macarena
Seville, 41009, Spain
Complejo Hospitalario Universitario de Vigo
Vigo, 36312, Spain
NCKUH
Tainan, 704, Taiwan
National Taiwan University Hospital
Taipei, 100, Taiwan
Golden Jubilee National Hospital
Clydebank, G81 4DY, United Kingdom
Leeds General Infirmary
Leeds, LS1 3EX, United Kingdom
Freeman Hospital
Newcastle upon Tyne, NE7 7DN, United Kingdom
Related Links
MeSH Terms
Conditions
Condition Hierarchy (Ancestors)
Study Design
- Study Type
- interventional
- Phase
- phase 2
- Allocation
- RANDOMIZED
- Masking
- TRIPLE
- Who Masked
- PARTICIPANT, CARE PROVIDER, INVESTIGATOR
- Masking Details
- Sponsor team is also masked
- Purpose
- TREATMENT
- Intervention Model
- PARALLEL
- Sponsor Type
- INDUSTRY
- Responsible Party
- SPONSOR
Study Record Dates
First Submitted
November 7, 2023
First Posted
November 18, 2023
Study Start
December 5, 2023
Primary Completion
September 2, 2025
Study Completion
December 2, 2025
Last Updated
February 4, 2026
Record last verified: 2026-02
Data Sharing
- IPD Sharing
- Will share
- Shared Documents
- STUDY PROTOCOL, SAP, CSR
- 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.
- 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.
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.