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

Launched by BOEHRINGER INGELHEIM · Nov 15, 2023

Keywords

ClinConnect Summary

The IRI-EXPLORE trial is studying a medication called BI 765845 to see if it can help people who have recently had a heart attack. This trial is open to adults aged 18 and older who have experienced a heart attack within a specific timeframe. To participate, individuals must meet certain criteria, such as being of non-childbearing potential and not having a history of severe heart issues.

Participants in the study will be randomly assigned to receive either the BI 765845 medication or a placebo, which looks like the medication but contains no active ingredients. They will be involved in the study for three months, attending seven visits and having three phone check-ins with the study team. During these visits, doctors will monitor heart health and check for any side effects. This research aims to find out how well the medication works and if it is safe for people recovering from a heart attack.

Gender

ALL

Eligibility criteria

• 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.