IRI-EXPLORE: A Study to Test Whether BI 765845 Helps People Who Have Had a Heart Attack (IRI-EXPLORE)

April 29, 2024 updated by: Boehringer Ingelheim

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

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.

Study Overview

Status

Recruiting

Conditions

Intervention / Treatment

Study Type

Interventional

Enrollment (Estimated)

350

Phase

  • Phase 2

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Contact

Study Locations

  • Australia
    • Victoria
      • Epping, Victoria, Australia, 3076
  • Canada
      • Quebec, Canada, G1V 4G5
        • Recruiting
        • IUCPQ (Laval University)
        • Contact:
    • Alberta
      • Edmonton, Alberta, Canada, T6G 2B7
        • Recruiting
        • University of Alberta Hospital (University of Alberta)
        • Contact:
    • Quebec
      • Montreal, Quebec, Canada, H2X 0C1
        • Recruiting
        • Centre hospitalier de l'Université de Montréal (CHUM)
        • Contact:
  • Germany
      • Berlin, Germany, 13353
      • Dresden, Germany, 01067
      • Frankfurt, Germany, 60590
      • Freiburg, Germany, 79106
        • Recruiting
        • Universitätsklinikum Freiburg Neurologische Klinik
        • Contact:
      • Langen, Germany, 63225
      • Leipzig, Germany, 04289
      • Leipzig, Germany, 04103
      • Ludwigshafen, Germany, 67063
        • Recruiting
        • Klinikum der Stadt Ludwigshafen am Rhein gGmbH
        • Contact:
      • Ulm, Germany, 89081
  • Hungary
  • Italy
      • Bari, Italy, 70124
      • Caserta, Italy, 81100
        • Recruiting
        • A.O. "S. Anna e San Sebastiano"
        • Contact:
      • Cona (FE), Italy, 44124
        • Recruiting
        • Azienda Ospedaliera Universitaria Arcispedale Sant'Anna
        • Contact:
      • Massa, Italy, 54100
        • Recruiting
        • Osp. Pediatrico Apuano Pasquinucci
        • Contact:
      • Torino, Italy, 10128
        • Recruiting
        • Ospedale Mauriziano di Torino
        • Contact:
  • Korea, Republic of
      • Seoul, Korea, Republic of, 03080
        • Suspended
        • Seoul National University Hospital
  • New Zealand
      • Grafton / Auckland, New Zealand, 1010
        • Suspended
        • Auckland City Hospital
  • Poland
      • Chrzanow, Poland, 32-500
        • Recruiting
        • American-Polish Heart Clinic, Lesser Poland Cardiovascular Centre
        • Contact:
      • Opole, Poland, 45-401
        • Recruiting
        • University Clinical Hospital in Opole
        • Contact:
      • Rzeszow, Poland, 35-111
        • Recruiting
        • Independent Public Health Care Center of the Ministry of the Interior in Rzeszow
        • Contact:
  • Slovakia
      • Banska Bystrica, Slovakia, 97401
        • Recruiting
        • Cardiovascular Diseases institute of Central Slovakia
        • Contact:
      • Nitra, Slovakia, 949 01
  • Spain
      • Madrid, Spain, 28009
        • Recruiting
        • Hospital General Universitario Gregorio Marañon
        • Contact:
      • Madrid, Spain, 28046
      • Santiago de Compostela, Spain, 15706
        • Recruiting
        • Complexo Hospitalario Universitario De Santiago
        • Contact:
      • Sevilla, Spain, 41009
      • Vigo, Spain, 36312
        • Recruiting
        • Complejo Hospitalario Universitario de Vigo
        • Contact:
  • United Kingdom
      • Clydebank, United Kingdom, G81 4DY
      • Leeds, United Kingdom, LS1 3EX
      • Newcastle upon Tyne, United Kingdom, NE7 7DN
        • Suspended
        • Freeman Hospital

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

  • Adult
  • Older Adult

Accepts Healthy Volunteers

No

Description

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 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.
  3. Known history of Heart Failure (HF) (based on verbal medical history as reported by a trial participant or authorised representative)
  4. 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)
  5. Previous coronary artery bypass grafting (CABG) (based on verbal medical history as reported by a trial participant or authorised representative) Further exclusion criteria apply.

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

  • Primary Purpose: Treatment
  • Allocation: Randomized
  • Interventional Model: Parallel Assignment
  • Masking: Triple

Arms and Interventions

Participant Group / Arm
Intervention / Treatment
Placebo Comparator: Placebo group
Drug: Placebo matching BI 765845
Placebo matching BI 765845
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

What is the study measuring?

Primary Outcome Measures

Outcome 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)
Time Frame: At Day 5
At Day 5

Secondary Outcome Measures

Outcome 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)
Time Frame: At Day 90
At Day 90
Difference in myocardial Infarct size (IS)
Time Frame: At Day 5 and Day 90
At Day 5 and Day 90

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

Boehringer Ingelheim

Publications and helpful links

The person responsible for entering information about the study voluntarily provides these publications. These may be about anything related to the study.

Helpful Links

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start (Actual)

November 24, 2023

Primary Completion (Estimated)

December 20, 2026

Study Completion (Estimated)

March 15, 2027

Study Registration Dates

First Submitted

November 7, 2023

First Submitted That Met QC Criteria

November 15, 2023

First Posted (Actual)

November 18, 2023

Study Record Updates

Last Update Posted (Actual)

April 30, 2024

Last Update Submitted That Met QC Criteria

April 29, 2024

Last Verified

April 1, 2024

More Information

Terms related to this study

Additional Relevant MeSH Terms

Other Study ID Numbers

  • 1478-0002
  • U1111-1291-6320 (Other Identifier: WHO/UTN)
  • 2022-502788-39-00 (Other Identifier: CTIS)

Plan for Individual participant data (IPD)

Plan to Share Individual Participant Data (IPD)?

YES

IPD Plan Description

Once the criteria in section "Time Frame" are fulfilled, researchers can use the following link https://www.mystudywindow.com/msw/datasharing to request access to the clinical study documents regarding this study, and upon a signed "Document Sharing Agreement".

Furthermore, researchers can request access to the clinical study data, for this and other listed studies, after the submission of a research proposal and according to the terms outlined in the website.

IPD Sharing Time Frame

One year after the approval has been granted by major regulatory authorities and after the primary manuscript has been accepted for publication, or after termination of the development program.

IPD Sharing Access Criteria

For study documents - upon signing of a 'Document Sharing Agreement'.

For study data - 1. after the submission and approval of the research proposal (checks will be performed by the sponsor and/or the independent review panel, including checking that the planned analysis does not compete with sponsor's publication plan); 2. and upon signing of a legal agreement.

IPD Sharing Supporting Information Type

  • STUDY_PROTOCOL
  • SAP
  • CSR

Drug and device information, study documents

Studies a U.S. FDA-regulated drug product

Yes

Studies a U.S. FDA-regulated device product

No

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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