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: 2025-07
• Last Update Submitted: 2025-07-21
• Last Update Posted: 2025-07-22
• 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 (105)

University of Arizona; 🇺🇸 Tucson, Arizona, United States

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

Hackensack University Medical Center; 🇺🇸 Hackensack, New Jersey, United States

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

Scroll for more (95 remaining)