Myocardial InfarctionPhase 2IRI-EXPLORENCT06139328
IRI-EXPLORE: A Study to Test Whether BI 765845 Helps People Who Have Had a Heart Attack
A Phase 2 study testing BI 765845 in people with Myocardial Infarction, run by Boehringer Ingelheim at 53 sites in 14 countries.
Trial 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. Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- Myocardial Infarction
- What is being tested?
- BI 765845
- Could I receive a placebo?
- Yes, some participants may receive a placebo
- How many people
- 160 participants
- Where
- 53 sitesin 14 countries
- Study dates
- 5 Dec 2023to 2 Dec 2025
- Phase
- Phase 2
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 years and older
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- 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:
- 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.
Who cannot join
- 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)
- Previous coronary artery bypass grafting (CABG) (based on verbal medical history as reported by a trial participant or authorised representative) Further exclusion criteria apply.
Trial locations and contacts
53 sites in 14 countries.
53 sites in 14 countries
Germany10 sites
Charité - Universitätsmedizin Berlin
Berlin, 13353
Städtisches Klinikum Dresden
Dresden, 01067
Universitätsklinikum Frankfurt
Frankfurt, 60590
Universitätsklinikum Freiburg
Freiburg im Breisgau, 79106
Medizinische Hochschule Hannover
Hanover, 30625
Asklepios Klinik Langen-Seligenstadt GmbH
Langen, 63225
Universität Leipzig
Leipzig, 04103
Helios Herzzentrum Leipzig GmbH
Leipzig, 04289
Klinikum der Stadt Ludwigshafen am Rhein GmbH
Ludwigshafen, 67063
Universitätsklinikum Ulm
Ulm, 89081
Italy6 sites
Ospedale San Paolo-Bari-18924
Bari, 70124
Azienda Ospedaliera Cannizzaro
Catania, 95126
Azienda Ospedaliera Universitaria Arcispedale Sant'Anna
Cona (FE), 44124
Osp. Pediatrico Apuano Pasquinucci
Massa, 54100
A.O. San Gerardo di Monza
Monza, 20900
Ospedale Mauriziano di Torino
Torino, 10128
Poland6 sites
American-Polish Heart Clinic, Lesser Poland Cardiovascular Centre
Chrzanów, 32-500
University Hospital in Krakow
Krakow, 30-688
Independent Public Health Care in Myszkow
Myszków, 42 300
University Clinical Hospital in Opole
Opole, 45-401
Independent Public Health Care Center of the Ministry of the Interior in Rzeszow
Rzeszów, 35-111
American Heart of Poland Sp. z o.o.-Tychy-44644
Tychy, 43-100
Spain6 sites
Hospital Santa Creu i Sant Pau
Barcelona, 08026
Hospital Universitari Vall d'Hebron
Barcelona, 08035
Hospital General Universitario Gregorio Marañón
Madrid, 28009
Hospital Universitario La Paz
Madrid, 28046
Hospital Universitario Virgen De La Macarena
Seville, 41009
Complejo Hospitalario Universitario de Vigo
Vigo, 36312
Canada4 sites
Hamilton General Hospital
Hamilton, Ontario, L8L 2X2
Centre Hospitalier de l'Universite de Montreal (CHUM)
Montreal, Quebec, H2X 0C1
University of Ottawa Heart Institute
Ottawa, Ontario, K1Y 4W7
Institut Universitaire de Cardiologie et de Pneumologie de Quebec (IUCPQ)
Québec, G1V 4G5
Czechia3 sites
St. Anna Hospital
Brno, 602 00
University Hospital Brno
Brno, 62500
General University Hospital
Prague, 128 00
Hungary3 sites
Semmelweis University
Budapest, 1122
University of Pecs
Pécs, 7624
Zala County Hospital, Zalaegerszeg
Zalaegerszeg, 8900
Singapore3 sites
National University Hospital-Singapore-42005
Singapore, 119074
National Heart Centre Singapore
Singapore, 169609
Sengkang General Hospital
Singapore, 544886
Slovakia3 sites
Cardiovascular Diseases institute of Central Slovakia
Banská Bystrica, 97401
National Institute of Cardiovascular Diseases
Bratislava, 831 01
Cardiocenter Nitra, s.r.o
Nitra, 949 01
United Kingdom3 sites
Golden Jubilee National Hospital
Clydebank, G81 4DY
Leeds General Infirmary
Leeds, LS1 3EX
Freeman Hospital
Newcastle upon Tyne, NE7 7DN
Australia2 sites
The Northern Hospital
Epping, Victoria, 3076
South Western Sydney Local Health District
Liverpool, New South Wales, 2170
About this study
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
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.
- Conditions
- Myocardial Infarction
- Being tested
- BI 765845, Placebo matching BI 765845
- Medical subject headings
- Myocardial Infarction
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
BI 765845Drug
BI 765845
Placebo matching BI 765845Drug
Placebo matching BI 765845
| Study group | Role | What they receive |
|---|---|---|
| BI 765845 very low dose group, administration type 1 | Experimental | Not described Receives: Drug: BI 765845 |
| BI 765845 low dose group, administration type 1 | Experimental | Not described Receives: Drug: BI 765845 |
| BI 765845 medium dose group, administration type 1 | Experimental | Not described Receives: Drug: BI 765845 |
| BI 765845 high dose group, administration type 1 | Experimental | Not described Receives: Drug: BI 765845 |
| Placebo group | Placebo comparator | Not described Receives: Drug: Placebo matching BI 765845 |
| BI 765845 low dose group, administration type 2 | Experimental | Not described Receives: Drug: BI 765845 |
| BI 765845 high dose group, administration type 2 | Experimental | Not described Receives: Drug: BI 765845 |
What is being measured
The primary outcome is the main question the study is designed to answer.
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)
Measured: 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)
Measured: At Day 90
Difference in myocardial Infarct size (IS)
Measured: At Day 5 and Day 90
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted18 Nov 2023
- Study start5 Dec 2023
- Primary completion2 Sep 2025
- Study completion2 Dec 2025
Why it stopped: Sponsor decision
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Myocardial InfarctionStudies of the same condition, open and under way.
- More trials run by Boehringer IngelheimThe sponsor's other registered studies.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase 2
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Triple blind
- Who is masked
- Participant, Care provider, Investigator
- Enrolment
- 160 participants (actual)
Sponsor and investigators
- Lead sponsor
- Boehringer Ingelheim
- Sponsor type
- Industry (pharma, biotech, devices)
- Responsible party
- Sponsor
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT06139328
- Sponsor's protocol ID
- 1478-0002
- Other IDs
- U1111-1291-6320, 2022-502788-39-00
- Acronym
- IRI-EXPLORE
- Status last verified
- Jul 2026
- First submitted
- 7 Nov 2023
- Last updated
- 27 Jul 2026
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- Yes
- FDA-regulated device
- No
- Individual data sharing
- Yes: 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.
Study at a glance
From the registry record, last updated by the sponsor on 27 Jul 2026. Recruitment status is as the sponsor reported it: confirm with the study team.
- 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
- ClinicalTrials.gov ID
- NCT06139328
- Acronym / sponsor ID
- IRI-EXPLORE / 1478-0002
- Conditions
- Myocardial Infarction
- Phase
- Phase 2
- Study type
- Interventional
- Recruitment status
- TerminatedReason stopped: Sponsor decision
- Enrolment
- 160 participants (actual)
- Lead sponsor
- Boehringer IngelheimIndustry (pharma, biotech, devices)
- Study start
- 5 Dec 2023 (actual)
- Primary completion
- 2 Sep 2025 (actual)
- Study completion
- 2 Dec 2025 (actual)
- First posted
- 18 Nov 2023 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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 design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Triple blind (participant, care provider, investigator)
- Number of arms
- 7
| Arm | Type | Receives |
|---|---|---|
| BI 765845 very low dose group, administration type 1 | Experimental | Drug: BI 765845 |
| BI 765845 low dose group, administration type 1 | Experimental | Drug: BI 765845 |
| BI 765845 medium dose group, administration type 1 | Experimental | Drug: BI 765845 |
| BI 765845 high dose group, administration type 1 | Experimental | Drug: BI 765845 |
| Placebo group | Placebo comparator | Drug: Placebo matching BI 765845 |
| BI 765845 low dose group, administration type 2 | Experimental | Drug: BI 765845 |
| BI 765845 high dose group, administration type 2 | Experimental | Drug: BI 765845 |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (5 listed)
- 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:
- 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.
Key exclusion criteria (6 listed)
- 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)
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| BI 765845BI 765845 | Drug | BI 765845 high dose group, administration type 1, BI 765845 high dose group, administration type 2, BI 765845 low dose group, administration type 1, BI 765845 low dose group, administration type 2, BI 765845 medium dose group, administration type 1, BI 765845 very low dose group, administration type 1 |
| Placebo matching BI 765845Placebo matching BI 765845 | Drug | Placebo group |
Primary outcome
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
2 secondary outcomes
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
Difference in myocardial Infarct size (IS)
Time frame: At Day 5 and Day 90
Results and safety
The study was stopped early (reason given: Sponsor decision). Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 27 Jul 2026.
- Related InfoLink provided by the sponsor.
- Individual participant dataSharing planned: Yes. 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.
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
The record lists no contact. Use the official record to reach the sponsor.
53 sites in 14 countries: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A Phase 2 study testing BI 765845 in people with Myocardial Infarction, run by Boehringer Ingelheim at 53 sites in 14 countries.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 5 inclusion and 6 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: stopped early, as of the sponsor's last update on 27 Jul 2026. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 53 sites in Germany, Italy, Poland, Spain, Canada and 9 more countries. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. Some participants in this study may receive a placebo. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
What does this phase mean?
Phase 2 studies give the treatment to a larger group to see whether it has the intended effect and to keep checking safety.
Not every study follows the same path, and some studies (observational studies, device studies) have no phase.
Are results available for this study?
The study was stopped early (reason given: Sponsor decision). Results are not available in the source record.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
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). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 27 Jul 2026.