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

Description

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 3 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.

Conditions

Myocardial Infarction

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Study Overview

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Study Details

Study overview

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 3 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.

Randomised Study for Double-blind, Placebo-controlled Evaluation of a Single Intravenous Infusion of BI 765845 and Partially-blinded Evaluation of a Single Bolus Administration of BI 765845 on Top of Standard of Care in Patients With Acute Myocardial Infarction

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

Condition
Myocardial Infarction
Intervention / Treatment

-

Contacts and Locations

Covina

Valley Clinical Trials, Inc., Covina, California, United States, 91723

Torrance

The Lundquist Institute for Biomedical Innovation at Harbor-UCLA Medical Center, Torrance, California, United States, 90502

Jacksonville

University of Florida Health Jacksonville, Jacksonville, Florida, United States, 32209

Tallahassee

Tallahassee Research Instutite, Tallahassee, Florida, United States, 32308

Springfield

Southern Illinois University School of Medicine, Springfield, Illinois, United States, 62702

Boston

Brigham and Women's Hospital, Boston, Massachusetts, United States, 02115

Minneapolis

Allina Health System, Minneapolis, Minnesota, United States, 55407

Buffalo

University at Buffalo, The State University of New York, Buffalo, New York, United States, 14203

Houston

The University of Texas Health Science Center at Houston, Houston, Texas, United States, 77030

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.

For general information about clinical research, read Learn About Studies.

Eligibility 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 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:
  • 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 persisting despite fluid challenge or inotropes/vasopressors use to maintain SBP \>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) Further exclusion criteria apply.

Ages Eligible for Study

18 Years to

Sexes Eligible for Study

ALL

Accepts Healthy Volunteers

No

Collaborators and Investigators

Boehringer Ingelheim,

Study Record Dates

2027-03-15