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

Myocardial Infarction Clinical Trial

— IRI-EXPLORE  

Official title:

Randomised, Double-blind, Placebo-controlled Study to Investigate a Single Administration of BI 765845 on Top of Standard of Care in Patients With Acute Myocardial Infarction

Clinical Trial Details — Status: Recruiting

Administrative data

• NCT number: NCT06139328
• Other study ID #: 1478-0002
• Secondary ID: U1111-1291-63202
• Status: Recruiting
• Phase: Phase 2
• Start date: November 24, 2023
• Est. completion date: March 15, 2027

Study information

• Verified date: April 2024
• Source: Boehringer Ingelheim
• Contact: Boehringer Ingelheim
• Phone: 1-800-243-0127
• Email: clintriage.rdg[@]boehringer-ingelheim.com
• Is FDA regulated: No
• Study type: Interventional

Clinical 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. 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 4 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.

Recruitment information / eligibility

• Status: Recruiting
• Enrollment: 350
• Est. completion date: March 15, 2027
• Est. primary completion date: December 20, 2026
• Accepts healthy volunteers: No
• Gender: All
• Age group: 18 Years and older

Eligibility

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 (either by the patient or impartial witness) 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 medicinal 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: =3 h and =8 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 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.

3. Known history of Heart Failure (HF) (based on verbal medical history as reported by a trial participant or authorised representative)

4. Known history of myocardial infarct (MI) with the exception of the index event (based on verbal medical history as reported by a trial participant or authorised representative)

5. Previous coronary artery bypass grafting (CABG) (based on verbal medical history as reported by a trial participant or authorised representative) Further exclusion criteria apply.

Related Conditions & MeSH terms

• Infarction
• Myocardial Infarction

Intervention

Drug:
• BI 765845
BI 765845
• Placebo matching BI 765845
Placebo matching BI 765845

Locations

Country	Name	City	State
Australia	The Northern Hospital	Epping	Victoria
Canada	University of Alberta Hospital (University of Alberta)	Edmonton	Alberta
Canada	Centre Hospitalier de l'Universite de Montreal (CHUM)	Montreal	Quebec
Canada	IUCPQ (Laval University)	Quebec
Germany	Charité - Universitätsmedizin Berlin	Berlin
Germany	Städtisches Klinikum Dresden	Dresden
Germany	Universitätsklinikum Frankfurt	Frankfurt
Germany	Universitätsklinikum Freiburg Neurologische Klinik	Freiburg
Germany	Asklepios Klinik Langen-Seligenstadt GmbH	Langen
Germany	Herzzentrum Leipzig GmbH	Leipzig
Germany	Universität Leipzig	Leipzig
Germany	Klinikum der Stadt Ludwigshafen am Rhein gGmbH	Ludwigshafen
Germany	Universitätsklinikum Ulm	Ulm
Hungary	Semmelweis University	Budapest
Hungary	University of Pecs	Pecs
Italy	Ospedale "San Paolo"	Bari
Italy	A.O. "S. Anna e San Sebastiano"	Caserta
Italy	Azienda Ospedaliera Universitaria Arcispedale Sant'Anna	Cona (FE)
Italy	Osp. Pediatrico Apuano Pasquinucci	Massa
Italy	Ospedale Mauriziano di Torino	Torino
Korea, Republic of	Seoul National University Hospital	Seoul
New Zealand	Auckland City Hospital	Grafton / Auckland
Poland	American-Polish Heart Clinic, Lesser Poland Cardiovascular Centre	Chrzanow
Poland	University Clinical Hospital in Opole	Opole
Poland	Independent Public Health Care Center of the Ministry of the Interior in Rzeszow	Rzeszow
Slovakia	Cardiovascular Diseases institute of Central Slovakia	Banska Bystrica
Slovakia	Cardiocenter Nitra, s.r.o	Nitra
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
United Kingdom	Golden Jubilee National Hospital	Clydebank
United Kingdom	Leeds General Infirmary	Leeds
United Kingdom	Freeman Hospital	Newcastle upon Tyne

Sponsors (1)

Lead Sponsor	Collaborator
Boehringer Ingelheim

Countries where clinical trial is conducted

Australia,  Canada,  Germany,  Hungary,  Italy,  Korea, Republic of,  New Zealand,  Poland,  Slovakia,  Spain,  United Kingdom, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	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	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
Secondary	Difference in myocardial Infarct size (IS)		At Day 5 and Day 90

External Links

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