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

Phase 2

Recruiting

• Conditions: Myocardial Infarction
• Interventions: Drug: Placebo matching BI 765845; Drug: BI 765845

• Registration Number: NCT06139328
• Lead Sponsor: Boehringer Ingelheim

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.

Detailed Description

Not available

Study Timeline

• Study First Submitted: 2023-11-07
• Study First Submitted QC: 2023-11-15
• Study First Posted: 2023-11-18
• Study Start: 2023-12-05
• Status Verified: 2025-05
• Last Update Submitted: 2025-05-26
• Last Update Posted: 2025-05-28
• Primary Completion: 2026-12-20
• Study Completion: 2027-03-15

Recruitment & Eligibility

• Status: RECRUITING
• Sex: All
• Target Recruitment: 350

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 & Design

• Study Type: INTERVENTIONAL
• Study Design: PARALLEL

Arm && Interventions

Group	Intervention	Description
Placebo group	Placebo matching BI 765845	-
BI 765845 low dose group, administration type 1	BI 765845	-
BI 765845 very low dose group, administration type 1	BI 765845	-
BI 765845 medium dose group, administration type 1	BI 765845	-
BI 765845 high dose group, administration type 1	BI 765845	-
BI 765845 high dose group, administration type 2	BI 765845	-
BI 765845 low dose group, administration type 2	BI 765845	-

Primary Outcome Measures

Name	Time	Method
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 Outcome Measures

Name	Time	Method
Difference in myocardial Infarct size (IS)	At Day 5 and Day 90
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

Trial Locations

Locations (98)

Flourish Research - Los Angeles (Covina) Clinical Research; 🇺🇸 Covina, California, United States

The Lundquist Institute for Biomedical Innovation at Harbor-UCLA Medical Center; 🇺🇸 Torrance, California, United States

Colorado Heart and Vascular PC; 🇺🇸 Golden, Colorado, United States

University of Florida Health Jacksonville; 🇺🇸 Jacksonville, Florida, United States

Southern Illinois University School of Medicine; 🇺🇸 Springfield, Illinois, United States

Brigham and Women's Hospital; 🇺🇸 Boston, Massachusetts, United States

Allina Health System; 🇺🇸 Minneapolis, Minnesota, United States

University at Buffalo, The State University of New York; 🇺🇸 Buffalo, New York, United States

Moses H. Cone Memorial Hospital; 🇺🇸 Greensboro, North Carolina, United States

University of Tennessee; 🇺🇸 Knoxville, Tennessee, United States

The University of Texas Health Science Center at Houston; 🇺🇸 Houston, Texas, United States

South Western Sydney Local Health District; 🇦🇺 Liverpool, New South Wales, Australia

The Prince Charles Hospital; 🇦🇺 Chermside, Queensland, Australia

The Northern Hospital; 🇦🇺 Epping, Victoria, Australia

Fiona Stanley Hospital; 🇦🇺 Murdoch, Western Australia, Australia

University of Calgary; 🇨🇦 Calgary, Alberta, Canada

University of Alberta Hospital (University of Alberta); 🇨🇦 Edmonton, Alberta, Canada

St. Boniface Hospital; 🇨🇦 Winnipeg, Manitoba, Canada

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

IUCPQ (Laval University); 🇨🇦 Quebec, Canada

University Hospital at St. Anna; 🇨🇿 Brno, Czechia

University Hospital Brno; 🇨🇿 Brno, Czechia

General University Hospital; 🇨🇿 Prague 2, Czechia

Charite Universitätsmedizin Berlin KöR; 🇩🇪 Berlin, Germany

St. Johannes Hospital Dortmund; 🇩🇪 Dortmund, Germany

Städtisches Klinikum Dresden; 🇩🇪 Dresden, Germany

Universitätsklinikum Frankfurt; 🇩🇪 Frankfurt, Germany

Universitätsklinikum Freiburg; 🇩🇪 Freiburg, Germany

Medizinische Hochschule Hannover; 🇩🇪 Hannover, Germany

Universitätsklinikum Heidelberg; 🇩🇪 Heidelberg, Germany

Asklepios Klinik Langen-Seligenstadt GmbH; 🇩🇪 Langen, Germany

Universität Leipzig; 🇩🇪 Leipzig, Germany

Herzzentrum Leipzig GmbH; 🇩🇪 Leipzig, Germany

Klinikum der Stadt Ludwigshafen am Rhein gGmbH; 🇩🇪 Ludwigshafen, Germany

Universitätsmedizin der Johannes Gutenberg-Universität Mainz; 🇩🇪 Mainz, Germany

Krankenhaus der Barmherzigen Brüder Trier; 🇩🇪 Trier, Germany

Universitätsklinikum Ulm; 🇩🇪 Ulm, Germany

Semmelweis University; 🇭🇺 Budapest, Hungary

University of Pecs; 🇭🇺 Pecs, Hungary

Zala County Hospital, Zalaegerszeg; 🇭🇺 Zalaegerszeg, Hungary

Ospedale San Paolo-Bari-18924; 🇮🇹 Bari, Italy

Fond. Poliambulanza Istituto; 🇮🇹 Brescia, Italy

A.O. "S. Anna e San Sebastiano"; 🇮🇹 Caserta, Italy

Azienda Ospedaliera Cannizzaro; 🇮🇹 Catania, Italy

Azienda Ospedaliera Universitaria Arcispedale Sant'Anna; 🇮🇹 Cona (FE), Italy

Azienda Ospedaliera San Martino; 🇮🇹 Genova, Italy

Osp. Pediatrico Apuano Pasquinucci; 🇮🇹 Massa, Italy

A.O. San Gerardo di Monza; 🇮🇹 Monza, Italy

Policlinico "Paolo Giaccone"; 🇮🇹 Palermo, Italy

Azienda Ospedaliera Ospedali Riuniti Villa Sofia - Cervello; 🇮🇹 Palermo, Italy

Ospedale di Rivoli (A.S.L. TO3); 🇮🇹 Rivoli (TO), Italy

A.O. San Camillo Forlanini; 🇮🇹 Roma, Italy

AOU Policlinico Umberto I; 🇮🇹 Roma, Italy

Ospedale Mauriziano di Torino; 🇮🇹 Torino, Italy

Mito Medical Center; 🇯🇵 Ibaraki, Higashiibaraki-gun, Japan

Yokohama City University Hospital; 🇯🇵 Kanagawa, Yokohama, Japan

Tohoku University Hospital; 🇯🇵 Miyagi, Sendai, Japan

Kawasaki Medical School Hospital; 🇯🇵 Okayama, Kurashiki, Japan

Kindai University Hospital; 🇯🇵 Osaka, Osakasayama, Japan

Keio University Hospital; 🇯🇵 Tokyo, Shinjuku-ku, Japan

Dong-A University Hospital; 🇰🇷 Busan, Korea, Republic of

Chonnam National University Hospital; 🇰🇷 Gwangju, Korea, Republic of

Seoul National University Hospital; 🇰🇷 Seoul, Korea, Republic of

Hanyang University Medical Center; 🇰🇷 Seoul, Korea, Republic of

Christchurch Public Hospital; 🇳🇿 Christchurch, New Zealand

Auckland City Hospital; 🇳🇿 Grafton / Auckland, New Zealand

American-Polish Heart Clinic, Lesser Poland Cardiovascular Centre; 🇵🇱 Chrzanow, Poland

University Hospital in Krakow; 🇵🇱 Krakow, Poland

Independent Public Health Care in Myszkow; 🇵🇱 Myszkow, Poland

University Clinical Hospital in Opole; 🇵🇱 Opole, Poland

Independent Public Health Care Center of the Ministry of the Interior in Rzeszow; 🇵🇱 Rzeszow, Poland

American Heart of Poland Sp. z o.o.-Tychy-44644; 🇵🇱 Tychy, Poland

Silesian Center for Heart Diseases; 🇵🇱 Zabrze, Poland

National University Hospital-Singapore-42005; 🇸🇬 Singapore, Singapore

National Heart Centre Singapore; 🇸🇬 Singapore, Singapore

Tan Tock Seng Hospital; 🇸🇬 Singapore, Singapore

Changi General Hospital; 🇸🇬 Singapore, Singapore

Sengkang General Hospital; 🇸🇬 Singapore, Singapore

Khoo Teck Puat Hospital; 🇸🇬 Singapore, Singapore

Cardiovascular Diseases institute of Central Slovakia; 🇸🇰 Banska Bystrica, Slovakia

National Institute of Cardiovascular Diseases; 🇸🇰 Bratislava, Slovakia

Cardiocenter Nitra, s.r.o; 🇸🇰 Nitra, Slovakia

Hospital Santa Creu i Sant Pau; 🇪🇸 Barcelona, Spain

Hospital Vall d'Hebron; 🇪🇸 Barcelona, Spain

Hospital Universitario Virgen de la Arrixaca; 🇪🇸 El Palmar, Spain

Hospital General Universitario Gregorio Marañón; 🇪🇸 Madrid, Spain

Hospital La Paz; 🇪🇸 Madrid, Spain

Complexo Hospitalario Universitario De Santiago; 🇪🇸 Santiago de Compostela, Spain

Hospital Virgen Macarena; 🇪🇸 Sevilla, 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

Wythenshawe Hospital; 🇬🇧 Manchester, United Kingdom

Freeman Hospital; 🇬🇧 Newcastle upon Tyne, United Kingdom