Myocardial Infarction
Conditions
Interventions
Adminitstr various dose of BI 765845 or Placebo
Sponsors
Saito Isao
Eligibility
Sex/Gender
All
Inclusion criteria
Inclusion criteria: 1. Age18 years or older (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) or more and 12 h or less prior to randomisation Part B: 1 hour (h) or more and 12 h or less prior to randomisation
Exclusion criteria
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 or more persisting despite fluid challenge or inotropes/vasopressors use to maintain SBP more than 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)
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| 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
| Measure | Time frame |
|---|---|
| 1.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 2. Difference in myocardial Infarct size (IS) at Day 5 and Day 90 | — |
Countries
Australia, Canada, Czechia, Germany, Hungary, Italy, Japan, New Zealand, Poland, Republic of Korea,, Singapore, Slovakia, Spain, Taiwan, United Kingdom, United States
Contacts
Public ContactYamagami Tomohiro
Boehringer Ingelheim
Outcome results
None listed