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

Last updated: November 25, 2024
Sponsor: Boehringer Ingelheim
Overall Status: Active - Recruiting

Phase

2

Condition

Blood Clots

Angina

Coronary Artery Disease

Treatment

Placebo matching BI 765845

BI 765845

Clinical Study ID

NCT06139328
1478-0002
2022-502788-39-00
U1111-1291-6320
  • Ages > 18
  • All Genders

Study 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.

Eligibility Criteria

Inclusion

Inclusion Criteria:

  1. Age ≥18 years (or legal age as per local regulations) at the time of signinginformed consent

  2. Signed and dated written informed consent (either by the patient or impartialwitness) in accordance with ICH Good Clinical Practice (GCP) and local legislationprior to admission to the trial

  3. Male or female participants of non-childbearing potential. Male participants must beready and able to use highly effective methods of birth control per ICH M3 (R2) forat least 5 days following investigational medicinal product (IMP) administration.Women who are not of childbearing potential are considered those that fulfil atleast one or more of the following: aged 50 years or above and being naturallyamenorrhoeic for at least 1 year (amenorrhoea following cancer therapy or duringbreast-feeding does not rule out childbearing potential) OR have premature ovarianfailure confirmed by a gynaecologist OR have undergone bilateralsalpingo-oophorectomy OR have undergone hysterectomy OR are affected by Turnersyndrome OR have uterine agenesis

  4. Onset of symptoms of myocardial ischaemia or myocardial infarct, according topatient 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

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 tomaintain SBP >90 mmHg.

  3. Known history of Heart Failure (HF) (based on verbal medical history as reported bya 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 authorisedrepresentative)

  5. Previous coronary artery bypass grafting (CABG) (based on verbal medical history asreported by a trial participant or authorised representative) Further exclusioncriteria apply.

Study Design

Total Participants: 350
Treatment Group(s): 2
Primary Treatment: Placebo matching BI 765845
Phase: 2
Study Start date:
December 05, 2023
Estimated Completion Date:
March 15, 2027

Connect with a study center

  • South Western Sydney Local Health District

    Liverpool, New South Wales 2170
    Australia

    Active - Recruiting

  • The Prince Charles Hospital

    Chermside, Queensland 4032
    Australia

    Site Not Available

  • The Northern Hospital

    Epping, Victoria 3076
    Australia

    Active - Recruiting

  • Fiona Stanley Hospital

    Murdoch, Western Australia 6150
    Australia

    Site Not Available

  • University of Calgary

    Calgary, Alberta T2N 4Z6
    Canada

    Active - Recruiting

  • University of Alberta Hospital (University of Alberta)

    Edmonton, Alberta T6G 2B7
    Canada

    Active - Recruiting

  • St. Boniface Hospital

    Winnipeg, Manitoba R2H 2A6
    Canada

    Site Not Available

  • Hamilton General Hospital

    Hamilton, Ontario L8L 2X2
    Canada

    Active - Recruiting

  • University of Ottawa Heart Institute

    Ottawa, Ontario K1Y 4W7
    Canada

    Active - Recruiting

  • Centre Hospitalier de l'Universite de Montreal (CHUM)

    Montreal, Quebec H2X 0C1
    Canada

    Active - Recruiting

  • IUCPQ (Laval University)

    Quebec, G1V 4G5
    Canada

    Active - Recruiting

  • University Hospital Brno

    Brno, 62500
    Czechia

    Site Not Available

  • University Hospital at St. Anna

    Brno, 602 00
    Czechia

    Site Not Available

  • General University Hospital

    Prague, 128 00
    Czechia

    Active - Recruiting

  • Masaryk Hospital, Usti nad Labem

    Usti nad Labem, 400 11
    Czechia

    Site Not Available

  • Charité - Universitätsmedizin Berlin

    Berlin, 13353
    Germany

    Active - Recruiting

  • Städtisches Klinikum Dresden

    Dresden, 01067
    Germany

    Active - Recruiting

  • Universitätsklinikum Frankfurt

    Frankfurt, 60590
    Germany

    Active - Recruiting

  • Universitätsklinikum Freiburg

    Freiburg, 79106
    Germany

    Active - Recruiting

  • Universitätsklinikum Freiburg Neurologische Klinik

    Freiburg, 79106
    Germany

    Site Not Available

  • Medizinische Hochschule Hannover

    Hannover, 30625
    Germany

    Active - Recruiting

  • Universitätsklinikum Heidelberg

    Heidelberg, 69120
    Germany

    Active - Recruiting

  • Asklepios Klinik Langen-Seligenstadt GmbH

    Langen, 63225
    Germany

    Active - Recruiting

  • Herzzentrum Leipzig GmbH

    Leipzig, 04289
    Germany

    Active - Recruiting

  • Universität Leipzig

    Leipzig, 04103
    Germany

    Active - Recruiting

  • Klinikum der Stadt Ludwigshafen am Rhein gGmbH

    Ludwigshafen, 67063
    Germany

    Active - Recruiting

  • Universitätsklinikum Ulm

    Ulm, 89081
    Germany

    Active - Recruiting

  • Semmelweis University

    Budapest, 1122
    Hungary

    Active - Recruiting

  • University of Pecs

    Pecs, 7624
    Hungary

    Active - Recruiting

  • Zala County Hospital, Zalaegerszeg

    Zalaegerszeg, 8900
    Hungary

    Active - Recruiting

  • Ospedale "San Paolo"

    Bari, 70124
    Italy

    Active - Recruiting

  • Ospedale San Paolo

    Bari, 70124
    Italy

    Active - Recruiting

  • A.O. "S. Anna e San Sebastiano"

    Caserta, 81100
    Italy

    Active - Recruiting

  • Azienda Ospedaliera Cannizzaro

    Catania, 95126
    Italy

    Active - Recruiting

  • Azienda Ospedaliera Universitaria Arcispedale Sant'Anna

    Cona (FE), 44124
    Italy

    Active - Recruiting

  • Azienda Ospedaliera San Martino

    Genova, 16132
    Italy

    Active - Recruiting

  • Osp. Pediatrico Aprano Pasquinucci

    Massa, 54100
    Italy

    Active - Recruiting

  • Osp. Pediatrico Apuano Pasquinucci

    Massa, 54100
    Italy

    Active - Recruiting

  • A.O. San Gerardo di Monza

    Monza, 20900
    Italy

    Active - Recruiting

  • Azienda Ospedaliera Ospedali Riuniti Villa Sofia - Cervello

    Palermo, 90146
    Italy

    Active - Recruiting

  • A.O. San Camillo Forlanini

    Roma, 00152
    Italy

    Site Not Available

  • AOU Policlinico Umberto I

    Roma, 00161
    Italy

    Active - Recruiting

  • Ospedale Mauriziano di Torino

    Torino, 10128
    Italy

    Active - Recruiting

  • Dong-A University Hospital

    Busan, 602-715
    Korea, Republic of

    Active - Recruiting

  • Chonnam National University Hospital

    Gwangju, 61453
    Korea, Republic of

    Active - Recruiting

  • Hanyang University Medical Center

    Seoul, 04763
    Korea, Republic of

    Active - Recruiting

  • Seoul National University Hospital

    Seoul, 03080
    Korea, Republic of

    Active - Recruiting

  • Christchurch Public Hospital

    Christchurch, 8011
    New Zealand

    Active - Recruiting

  • Auckland City Hospital

    Grafton / Auckland, 1010
    New Zealand

    Active - Recruiting

  • American-Polish Heart Clinic, Lesser Poland Cardiovascular Centre

    Chrzanow, 32-500
    Poland

    Active - Recruiting

  • University Hospital in Krakow

    Krakow, 30-688
    Poland

    Site Not Available

  • Med Univ of Lodz Provincial Specialist Hospital On Bieganski

    Lodz, 91347
    Poland

    Site Not Available

  • Independent Public Health Care in Myszkow

    Myszkow, 42 300
    Poland

    Active - Recruiting

  • University Clinical Hospital in Opole

    Opole, 45-401
    Poland

    Active - Recruiting

  • Independent Public Health Care Center of the Ministry of the Interior in Rzeszow

    Rzeszow, 35-111
    Poland

    Active - Recruiting

  • American Heart of Poland Sp. z o.o.

    Tychy, 43-100
    Poland

    Active - Recruiting

  • Silesian Center for Heart Diseases

    Zabrze, 41-800
    Poland

    Site Not Available

  • Changi General Hospital

    Singapore, 529889
    Singapore

    Site Not Available

  • Khoo Teck Puat Hospital

    Singapore, 768828
    Singapore

    Site Not Available

  • National Heart Center

    Singapore, 169609
    Singapore

    Active - Recruiting

  • National University Hospital-Singapore-42005

    Singapore, 119074
    Singapore

    Site Not Available

  • Sengkang General Hospital

    Singapore, 544886
    Singapore

    Site Not Available

  • Tan Tock Seng Hospital

    Singapore, 308433
    Singapore

    Site Not Available

  • Cardiovascular Diseases institute of Central Slovakia

    Banska Bystrica, 97401
    Slovakia

    Active - Recruiting

  • National Institute of Cardiovascular Diseases

    Bratislava, 831 01
    Slovakia

    Active - Recruiting

  • Cardiocenter Nitra, s.r.o

    Nitra, 949 01
    Slovakia

    Active - Recruiting

  • Hospital Santa Creu i Sant Pau

    Barcelona, 08026
    Spain

    Active - Recruiting

  • Hospital Vall d'Hebron

    Barcelona, 08035
    Spain

    Active - Recruiting

  • Hospital Universitario Virgen de la Arrixaca

    El Palmar, 30120
    Spain

    Active - Recruiting

  • Hospital General Universitario Gregorio Marañón

    Madrid, 28009
    Spain

    Active - Recruiting

  • Hospital La Paz

    Madrid, 28046
    Spain

    Active - Recruiting

  • Complexo Hospitalario Universitario De Santiago

    Santiago de Compostela, 15706
    Spain

    Active - Recruiting

  • Hospital Virgen Macarena

    Sevilla, 41009
    Spain

    Active - Recruiting

  • Complejo Hospitalario Universitario de Vigo

    Vigo, 36312
    Spain

    Active - Recruiting

  • NCKUH

    Tainan, 704
    Taiwan

    Active - Recruiting

  • National Taiwan University Hospital

    Taipei, 100
    Taiwan

    Active - Recruiting

  • Golden Jubilee National Hospital

    Clydebank, G81 4DY
    United Kingdom

    Active - Recruiting

  • Leeds General Infirmary

    Leeds, LS1 3EX
    United Kingdom

    Active - Recruiting

  • Wythenshawe Hospital

    Manchester, M23 9LT
    United Kingdom

    Site Not Available

  • Freeman Hospital

    Newcastle upon Tyne, NE7 7DN
    United Kingdom

    Active - Recruiting

  • Valley Clinical Trials, Inc.

    Covina, California 91723
    United States

    Site Not Available

  • The Lundquist Institute for Biomedical Innovation at Harbor-UCLA Medical Center

    Torrance, California 90502
    United States

    Site Not Available

  • University of Florida Health Jacksonville

    Jacksonville, Florida 32209
    United States

    Site Not Available

  • Tallahassee Research Instutite

    Tallahassee, Florida 32308
    United States

    Site Not Available

  • Allina Health System

    Minneapolis, Minnesota 55407
    United States

    Site Not Available

  • University at Buffalo, The State University of New York

    Buffalo, New York 14203
    United States

    Site Not Available

  • The University of Texas Health Science Center at Houston

    Houston, Texas 77030
    United States

    Site Not Available

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