A study to test whether BI 765845 helps people who have had a heart attack
- Conditions
- acute myocardial infarctionMedDRA version: 20.0Level: PTClassification code: 10000891Term: Acute myocardial infarction Class: 100000004849Therapeutic area: Diseases [C] - Cardiovascular Diseases [C14]
- Registration Number
- CTIS2022-502788-39-00
- Lead Sponsor
- Boehringer Ingelheim International GmbH
- Brief Summary
Not available
- Detailed Description
Not available
Recruitment & Eligibility
- Status
- Recruiting
- Sex
- All
- Target Recruitment
- 217
Age =18 years (or legal age as per local regulations) at the time of signing informed consent, 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, 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 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: =3 h and =8 h prior to randomisation - Part B: =1 h and =12 h prior to randomisation, Further criteria apply.
Women of childbearing potential, Patients indicated for rescue PCI (i.e. after receiving fibrinolysis), Patients with Left Bundle Branch Block (LBBB), Patients presenting with cardiogenic shock defined as either SBP =90 mmHg persisting despite fluid challenge or inotropes/vasopressors use to maintain SBP >90 mmHg., Known history of HF (based on verbal medical history as reported by a trial participant or authorised representative), Known history of 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 criteria apply.
Study & Design
- Study Type
- Interventional clinical trial of medicinal product
- Study Design
- Not specified
- Primary Outcome Measures
Name Time Method Main Objective: To assess efficacy of BI 765845 compared with placebo<br>To assess the safety and tolerability of BI 765845 <br>To characterize the dose-response relationship for BI 765845 in patients with MI by assessing doses and placebo, and to identify the best dose of BI 765845 to be used in the subsequent Phase III trial;Secondary Objective: To analyse myocardial IS measured using CMR at Day 5 and Day 90, To assess clinical efficacy at Day 90 measured by assessing several specific clinical parameters, To assess safety until Day 90 assessed by the occurrence of serious adverse events (SAEs) and drug-related adverse events;Primary end point(s): Infarct severity
- Secondary Outcome Measures
Name Time Method