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A Study to Test Whether BI 765845 Helps People Who Have Had an Acute Heart Attack

Sponsor
Boehringer Ingelheim (Industry)
Overall Status
Not yet recruiting
CT.gov ID
NCT06139328
Collaborator
(none)
350
Enrollment
5
Arms
39.9
Anticipated Duration (Months)

Study Details

Study Description

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. The investigators also want to test how well different doses of BI 765845 work and how they are tolerated by people who have had a heart attack.

Participants are randomly assigned to receive either BI 765845 or placebo. Placebo treatments look like BI 765845 treatments but do not contain any medicine. Participants are about 4 times as likely to receive BI 765845 than placebo.

Participants are in the study for 3 months. During this time, they visit the study site 7 times and get 3 phone calls from the site staff. At the visits, the doctors use clinical tests to check the health of the heart. The results are compared between the BI 765845 and placebo groups to see whether the treatment works. The doctors also regularly check participants 'health and take note of any unwanted effects.

Condition or Disease Intervention/Treatment Phase
  • Drug: BI 765845
  • Drug: Placebo matching BI 765845
 Phase 2

Study Design

Study Type:
Interventional
Anticipated Enrollment :
350 participants
Allocation:
Randomized
Intervention Model:
Parallel Assignment
Masking:
Triple (Participant, Care Provider, Investigator)
Masking Description:
Sponsor team is also masked
Primary Purpose:
Treatment
Official Title:
Randomised, Double-blind, Placebo-controlled Study to Investigate a Single Administration of BI 765845 on Top of Standard of Care in Patients With Acute Myocardial Infarction
Anticipated Study Start Date :
Nov 16, 2023
Anticipated Primary Completion Date :
Dec 20, 2026
Anticipated Study Completion Date :
Mar 15, 2027

Arms and Interventions

Arm Intervention/Treatment
Experimental: BI 765845 very low dose group

Drug: BI 765845
BI 765845
Experimental: BI 765845 low dose group

Drug: BI 765845
BI 765845
Experimental: BI 765845 medium dose group

Drug: BI 765845
BI 765845
Experimental: BI 765845 high dose group

Drug: BI 765845
BI 765845
Placebo Comparator: Placebo group

Drug: Placebo matching BI 765845
Placebo matching BI 765845

Outcome Measures

Primary Outcome Measures

  1. Infarct severity [At Day 5]

Secondary Outcome Measures

  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]

Eligibility Criteria

Criteria

Ages Eligible for Study:
18 Years and Older
Sexes Eligible for Study:
All
Accepts Healthy Volunteers:
No
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 (either by the patient or impartial witness) 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 medicinal 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: ≥3 h and ≤8 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 with Left Bundle Branch Block (LBBB)

  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 Heart Failure (HF) (based on verbal medical history as reported by a trial participant or authorised representative)

  5. Known history of myocardial infarct (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.

Contacts and Locations

Locations

No locations specified.

Sponsors and Collaborators

  • Boehringer Ingelheim

Investigators

None specified.

Study Documents (Full-Text)

None provided.

More Information

Additional Information:

Publications

None provided.
Responsible Party:
Boehringer Ingelheim
ClinicalTrials.gov Identifier:
NCT06139328
Other Study ID Numbers:
  • 1478-0002
  • U1111-1291-6320
  • 2022-502788-39-00
First Posted:
Nov 18, 2023
Last Update Posted:
Nov 18, 2023
Last Verified:
Nov 1, 2023
Individual Participant Data (IPD) Sharing Statement:
Yes
Plan to Share IPD:
Yes
Studies a U.S. FDA-regulated Drug Product:
Yes
Studies a U.S. FDA-regulated Device Product:
No
Additional relevant MeSH terms:
Myocardial Infarction
Infarction

Study Results

No Results Posted as of Nov 18, 2023