Status:
TERMINATED
IRI-EXPLORE: A Study to Test Whether BI 765845 Helps People Who Have Had a Heart Attack
Lead Sponsor:
Boehringer Ingelheim
Conditions:
Myocardial Infarction
Eligibility:
All Genders
18+ years
Phase:
PHASE2
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. T...
Eligibility Criteria
Inclusion
- Age ≥18 years (or legal age as per local regulations) at the time of signing informed consent
- Signed and dated written informed consent in accordance with ICH Good Clinical Practice (GCP) and local legislation prior to admission to the trial.
- 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
- 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
- Women of childbearing potential
- Patients indicated for rescue PCI (i.e. after receiving fibrinolysis)
- 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.
- 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
- 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)
- Previous coronary artery bypass grafting (CABG) (based on verbal medical history as reported by a trial participant or authorised representative) Further exclusion criteria apply.
Key Trial Info
Start Date :
December 5 2023
Trial Type :
INTERVENTIONAL
Allocation :
ACTUAL
End Date :
December 2 2025
Estimated Enrollment :
160 Patients enrolled
Trial Details
Trial ID
NCT06139328
Start Date
December 5 2023
End Date
December 2 2025
Last Update
December 17 2025
Active Locations (53)
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1
South Western Sydney Local Health District
Liverpool, New South Wales, Australia, 2170
2
The Northern Hospital
Epping, Victoria, Australia, 3076
3
Hamilton General Hospital
Hamilton, Ontario, Canada, L8L 2X2
4
University of Ottawa Heart Institute
Ottawa, Ontario, Canada, K1Y 4W7