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

NCT ID: NCT06139328

Last Updated: 2025-11-12

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

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Recruitment Status

ACTIVE_NOT_RECRUITING

Clinical Phase

PHASE2

Total Enrollment

160 participants

Study Classification

INTERVENTIONAL

Study Start Date

2023-12-05

Study Completion Date

2025-12-03

Brief Summary

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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

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Conditions

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Myocardial Infarction

Study Design

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Allocation Method

RANDOMIZED

Intervention Model

PARALLEL

Primary Study Purpose

TREATMENT

Blinding Strategy

TRIPLE

Participants Caregivers Investigators
Sponsor team is also masked

Study Groups

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BI 765845 very low dose group, administration type 1

Group Type EXPERIMENTAL

BI 765845

Intervention Type DRUG

BI 765845

BI 765845 low dose group, administration type 1

Group Type EXPERIMENTAL

BI 765845

Intervention Type DRUG

BI 765845

BI 765845 medium dose group, administration type 1

Group Type EXPERIMENTAL

BI 765845

Intervention Type DRUG

BI 765845

BI 765845 high dose group, administration type 1

Group Type EXPERIMENTAL

BI 765845

Intervention Type DRUG

BI 765845

Placebo group

Group Type PLACEBO_COMPARATOR

Placebo matching BI 765845

Intervention Type DRUG

Placebo matching BI 765845

BI 765845 low dose group, administration type 2

Group Type EXPERIMENTAL

BI 765845

Intervention Type DRUG

BI 765845

BI 765845 high dose group, administration type 2

Group Type EXPERIMENTAL

BI 765845

Intervention Type DRUG

BI 765845

Interventions

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BI 765845

BI 765845

Intervention Type DRUG

Placebo matching BI 765845

Placebo matching BI 765845

Intervention Type DRUG

Eligibility Criteria

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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:

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)
Minimum Eligible Age

18 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

No

Sponsors

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Boehringer Ingelheim

INDUSTRY

Sponsor Role lead

Responsible Party

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Responsibility Role SPONSOR

Locations

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South Western Sydney Local Health District

Liverpool, New South Wales, Australia

Site Status

The Northern Hospital

Epping, Victoria, Australia

Site Status

Hamilton General Hospital

Hamilton, Ontario, Canada

Site Status

University of Ottawa Heart Institute

Ottawa, Ontario, Canada

Site Status

Centre Hospitalier de l'Universite de Montreal (CHUM)

Montreal, Quebec, Canada

Site Status

IUCPQ (Laval University)

Québec, , Canada

Site Status

University Hospital at St. Anna

Brno, , Czechia

Site Status

University Hospital Brno

Brno, , Czechia

Site Status

General University Hospital

Prague, , Czechia

Site Status

Charite Universitätsmedizin Berlin KöR

Berlin, , Germany

Site Status

Städtisches Klinikum Dresden

Dresden, , Germany

Site Status

Universitätsklinikum Frankfurt

Frankfurt, , Germany

Site Status

Universitätsklinikum Freiburg

Freiburg im Breisgau, , Germany

Site Status

Medizinische Hochschule Hannover

Hanover, , Germany

Site Status

Asklepios Klinik Langen-Seligenstadt GmbH

Langen, , Germany

Site Status

Universität Leipzig

Leipzig, , Germany

Site Status

Helios Herzzentrum Leipzig GmbH

Leipzig, , Germany

Site Status

Klinikum der Stadt Ludwigshafen am Rhein GmbH

Ludwigshafen, , Germany

Site Status

Universitätsklinikum Ulm

Ulm, , Germany

Site Status

Semmelweis University

Budapest, , Hungary

Site Status

University of Pecs

Pécs, , Hungary

Site Status

Zala County Hospital, Zalaegerszeg

Zalaegerszeg, , Hungary

Site Status

Ospedale San Paolo-Bari-18924

Bari, , Italy

Site Status

Azienda Ospedaliera Cannizzaro

Catania, , Italy

Site Status

Azienda Ospedaliera Universitaria Arcispedale Sant'Anna

Cona (FE), , Italy

Site Status

Osp. Pediatrico Apuano Pasquinucci

Massa, , Italy

Site Status

A.O. San Gerardo di Monza

Monza, , Italy

Site Status

Ospedale Mauriziano di Torino

Torino, , Italy

Site Status

Auckland City Hospital

Grafton / Auckland, , New Zealand

Site Status

American-Polish Heart Clinic, Lesser Poland Cardiovascular Centre

Chrzanów, , Poland

Site Status

University Hospital in Krakow

Krakow, , Poland

Site Status

Independent Public Health Care in Myszkow

Myszków, , Poland

Site Status

University Clinical Hospital in Opole

Opole, , Poland

Site Status

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

Rzeszów, , Poland

Site Status

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

Tychy, , Poland

Site Status

National University Hospital-Singapore-42005

Singapore, , Singapore

Site Status

National Heart Centre Singapore

Singapore, , Singapore

Site Status

Sengkang General Hospital

Singapore, , Singapore

Site Status

Cardiovascular Diseases institute of Central Slovakia

Banská Bystrica, , Slovakia

Site Status

National Institute of Cardiovascular Diseases

Bratislava, , Slovakia

Site Status

Cardiocenter Nitra, s.r.o

Nitra, , Slovakia

Site Status

Hanyang University Medical Center

Seoul, , South Korea

Site Status

Hospital Santa Creu i Sant Pau

Barcelona, , Spain

Site Status

Hospital Universitari Vall D Hebron

Barcelona, , Spain

Site Status

Hospital General Universitario Gregorio Marañón

Madrid, , Spain

Site Status

Hospital Universitario La Paz

Madrid, , Spain

Site Status

Hospital Universitario Virgen De La Macarena

Seville, , Spain

Site Status

Complejo Hospitalario Universitario de Vigo

Vigo, , Spain

Site Status

NCKUH

Tainan, , Taiwan

Site Status

National Taiwan University Hospital

Taipei, , Taiwan

Site Status

Golden Jubilee National Hospital

Clydebank, , United Kingdom

Site Status

Leeds General Infirmary

Leeds, , United Kingdom

Site Status

Freeman Hospital

Newcastle upon Tyne, , United Kingdom

Site Status

Countries

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Japan United States Australia Canada Czechia Germany Hungary Italy New Zealand Poland Singapore Slovakia South Korea Spain Taiwan United Kingdom

Related Links

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http://www.mystudywindow.com

Related Info

Other Identifiers

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U1111-1291-6320

Identifier Type: OTHER

Identifier Source: secondary_id

2022-502788-39-00

Identifier Type: OTHER

Identifier Source: secondary_id

1478-0002

Identifier Type: -

Identifier Source: org_study_id