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A study to test whether BI 765845 helps people who have had a heart attack
EU CTIS ID: 2022-502788-39-00
What this study is testing
To assess efficacy of BI 765845 compared with placebo To assess the safety and tolerability of BI 765845 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
- Therapeutic exploratory (Phase II)
A plain-language read of the study's public EU CTIS listing. The study team confirms the details.
Who can take part
You may be able to join if
- 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: ≥1 h and ≤12 h prior to randomisation - Part B: ≥1 h and ≤12 h prior to randomisation"
- Further criteria apply.
You likely can't join if
- Women of childbearing potential
- Patients indicated for rescue PCI (i.e. after receiving fibrinolysis)
- 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 symptomatic 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 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)
See the full eligibility criteria
- 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: ≥1 h and ≤12 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 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 symptomatic 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 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.
The study team makes the final eligibility decision.
Where it's taking place
- Japan
- Singapore
- United States
- Australia
- Canada
- New Zealand
- United Kingdom
- Korea, Republic of
- Taiwan
Questions & answers
Do participants get paid in this trial?
This listing doesn't specify compensation. Many trials still reimburse travel or offer a stipend, so it's worth asking the study team when you connect.
Is it free to join, and do I need insurance?
Searching and applying through BridgeMD is free. In clinical trials the study-related treatment and visits are generally provided at no cost to you. You usually don't need insurance to take part - confirm specifics with the study team.
How long does this study last?
The listing doesn't state an exact length. The study team walks you through the schedule and number of visits before you decide to enroll.
Who can join this trial?
This study is enrolling all sexes, 18-64 years, 65+ years. The study team makes the final eligibility decision.
Where is this trial taking place?
Study sites include Japan; Singapore; United States; Australia; Canada; New Zealand and 3 more location(s). Enter your location above to see the nearest site and check your eligibility.
Explore other conditions
BridgeMD is an information and trial-matching tool - not medical advice, and not the study sponsor. Details come from EU CTIS; the study team decides eligibility.