Clinical trial NCT06139328: IRI-EXPLORE: A Study to Test Whether BI 765845 Helps People Who Have Had a Heart Attack
Official title: 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
Study type: INTERVENTIONAL
Overall status: RECRUITING
Phase: PHASE2
Conditions: Myocardial Infarction
Lead sponsor: Boehringer Ingelheim
Sponsor class: INDUSTRY
First posted: 2023-11-18
Enrollment: 350
Sex: ALL
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: TREATMENT

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 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.


Eligibility criteria: 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 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:

Part A: ≥1 hour (h) and ≤12 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 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.

Primary outcomes:
measure: 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)
timeFrame: At Day 5
Secondary outcomes:
measure: 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)
timeFrame: At Day 90
measure: Difference in myocardial Infarct size (IS)
timeFrame: At Day 5 and Day 90
Other outcomes:
Locations:
city: Tucson
country: United States
facility: University of Arizona
state: Arizona
city: Covina
country: United States
facility: Flourish Research - Los Angeles (Covina) Clinical Research
state: California
city: Torrance
country: United States
facility: The Lundquist Institute for Biomedical Innovation at Harbor-UCLA Medical Center
state: California
city: Golden
country: United States
facility: Colorado Heart and Vascular PC
state: Colorado
city: Jacksonville
country: United States
facility: University of Florida Health Jacksonville
state: Florida
city: Springfield
country: United States
facility: Southern Illinois University School of Medicine
state: Illinois
city: Boston
country: United States
facility: Brigham and Women's Hospital
state: Massachusetts
city: Minneapolis
country: United States
facility: Allina Health System
state: Minnesota
city: Hackensack
country: United States
facility: Hackensack University Medical Center
state: New Jersey
city: Buffalo
country: United States
facility: University at Buffalo, The State University of New York
state: New York
city: Greensboro
country: United States
facility: Moses H. Cone Memorial Hospital
state: North Carolina
city: Knoxville
country: United States
facility: University of Tennessee
state: Tennessee
city: Houston
country: United States
facility: The University of Texas Health Science Center at Houston
state: Texas
city: Liverpool
country: Australia
facility: South Western Sydney Local Health District
state: New South Wales
city: Chermside
country: Australia
facility: The Prince Charles Hospital
state: Queensland
city: Epping
country: Australia
facility: The Northern Hospital
state: Victoria
city: Murdoch
country: Australia
facility: Fiona Stanley Hospital
state: Western Australia
city: Calgary
country: Canada
facility: University of Calgary
state: Alberta
city: Edmonton
country: Canada
facility: University of Alberta Hospital (University of Alberta)
state: Alberta
city: Winnipeg
country: Canada
facility: St. Boniface Hospital
state: Manitoba
city: Hamilton
country: Canada
facility: Hamilton General Hospital
state: Ontario
city: Ottawa
country: Canada
facility: University of Ottawa Heart Institute
state: Ontario
city: Montreal
country: Canada
facility: Centre Hospitalier de l'Universite de Montreal (CHUM)
state: Quebec
city: Quebec
country: Canada
facility: IUCPQ (Laval University)
city: Brno
country: Czechia
facility: University Hospital at St. Anna
city: Brno
country: Czechia
facility: University Hospital Brno
city: Prague 2
country: Czechia
facility: General University Hospital
city: Berlin
country: Germany
facility: Charite Universitätsmedizin Berlin KöR
city: Dortmund
country: Germany
facility: St. Johannes Hospital Dortmund
city: Dresden
country: Germany
facility: Städtisches Klinikum Dresden
city: Frankfurt
country: Germany
facility: Universitätsklinikum Frankfurt
city: Freiburg
country: Germany
facility: Universitätsklinikum Freiburg
city: Hannover
country: Germany
facility: Medizinische Hochschule Hannover
city: Heidelberg
country: Germany
facility: Universitätsklinikum Heidelberg
city: Langen
country: Germany
facility: Asklepios Klinik Langen-Seligenstadt GmbH
city: Leipzig
country: Germany
facility: Universität Leipzig
city: Leipzig
country: Germany
facility: Herzzentrum Leipzig GmbH
city: Ludwigshafen
country: Germany
facility: Klinikum der Stadt Ludwigshafen am Rhein gGmbH
city: Mainz
country: Germany
facility: Universitätsmedizin der Johannes Gutenberg-Universität Mainz
city: Trier
country: Germany
facility: Krankenhaus der Barmherzigen Brüder Trier
city: Ulm
country: Germany
facility: Universitätsklinikum Ulm
city: Budapest
country: Hungary
facility: Semmelweis University
city: Pecs
country: Hungary
facility: University of Pecs
city: Zalaegerszeg
country: Hungary
facility: Zala County Hospital, Zalaegerszeg
city: Bari
country: Italy
facility: Ospedale San Paolo-Bari-18924
city: Brescia
country: Italy
facility: Fond. Poliambulanza Istituto
city: Caserta
country: Italy
facility: A.O. "S. Anna e San Sebastiano"
city: Catania
country: Italy
facility: Azienda Ospedaliera Cannizzaro
city: Cona (FE)
country: Italy
facility: Azienda Ospedaliera Universitaria Arcispedale Sant'Anna
city: Genova
country: Italy
facility: Azienda Ospedaliera San Martino
city: Massa
country: Italy
facility: Osp. Pediatrico Apuano Pasquinucci
city: Monza
country: Italy
facility: A.O. San Gerardo di Monza
city: Palermo
country: Italy
facility: Azienda Ospedaliera Universitaria Policlinico Paolo Giaccone
city: Palermo
country: Italy
facility: Azienda Ospedaliera Ospedali Riuniti Villa Sofia - Cervello
city: Rivoli (TO)
country: Italy
facility: Ospedale di Rivoli (A.S.L. TO3)
city: Roma
country: Italy
facility: A.O. San Camillo Forlanini
city: Roma
country: Italy
facility: AOU Policlinico Umberto I
city: Torino
country: Italy
facility: Ospedale Mauriziano di Torino
city: Ibaraki, Higashiibaraki-gun
country: Japan
facility: Mito Medical Center
city: Kanagawa, Yokohama
country: Japan
facility: Yokohama City University Hospital
city: Miyagi, Sendai
country: Japan
facility: Tohoku University Hospital
city: Okayama, Kurashiki
country: Japan
facility: Kawasaki Medical School Hospital
city: Osaka, Osakasayama
country: Japan
facility: Kindai University Hospital
city: Tokyo, Shinjuku-ku
country: Japan
facility: Keio University Hospital
city: Busan
country: Korea, Republic of
facility: Dong-A University Hospital
city: Gwangju
country: Korea, Republic of
facility: Chonnam National University Hospital
city: Seoul
country: Korea, Republic of
facility: Seoul National University Hospital
city: Seoul
country: Korea, Republic of
facility: Hanyang University Medical Center
city: Christchurch
country: New Zealand
facility: Christchurch Public Hospital
city: Grafton / Auckland
country: New Zealand
facility: Auckland City Hospital
city: Chrzanow
country: Poland
facility: American-Polish Heart Clinic, Lesser Poland Cardiovascular Centre
city: Krakow
country: Poland
facility: University Hospital in Krakow
city: Myszkow
country: Poland
facility: Independent Public Health Care in Myszkow
city: Opole
country: Poland
facility: University Clinical Hospital in Opole
city: Rzeszow
country: Poland
facility: Independent Public Health Care Center of the Ministry of the Interior in Rzeszow
city: Tychy
country: Poland
facility: American Heart of Poland Sp. z o.o.-Tychy-44644
city: Zabrze
country: Poland
facility: Silesian Center for Heart Diseases
city: Singapore
country: Singapore
facility: National University Hospital-Singapore-42005
city: Singapore
country: Singapore
facility: National Heart Centre Singapore
city: Singapore
country: Singapore
facility: Tan Tock Seng Hospital
city: Singapore
country: Singapore
facility: Changi General Hospital
city: Singapore
country: Singapore
facility: Sengkang General Hospital
city: Singapore
country: Singapore
facility: Khoo Teck Puat Hospital
city: Banska Bystrica
country: Slovakia
facility: Cardiovascular Diseases institute of Central Slovakia
city: Bratislava
country: Slovakia
facility: National Institute of Cardiovascular Diseases
city: Nitra
country: Slovakia
facility: Cardiocenter Nitra, s.r.o
city: Barcelona
country: Spain
facility: Hospital Santa Creu i Sant Pau
city: Barcelona
country: Spain
facility: Hospital Vall d'Hebron
city: El Palmar
country: Spain
facility: Hospital Universitario Virgen de la Arrixaca
city: Madrid
country: Spain
facility: Hospital General Universitario Gregorio Marañón
city: Madrid
country: Spain
facility: Hospital La Paz
city: Santiago de Compostela
country: Spain
facility: Complexo Hospitalario Universitario De Santiago
city: Sevilla
country: Spain
facility: Hospital Virgen Macarena
city: Vigo
country: Spain
facility: Complejo Hospitalario Universitario de Vigo
city: Tainan
country: Taiwan
facility: NCKUH
city: Taipei
country: Taiwan
facility: National Taiwan University Hospital
city: Clydebank
country: United Kingdom
facility: Golden Jubilee National Hospital
city: Leeds
country: United Kingdom
facility: Leeds General Infirmary
city: London
country: United Kingdom
facility: St Bartholomew's Hospital
city: Manchester
country: United Kingdom
facility: Wythenshawe Hospital
city: Newcastle upon Tyne
country: United Kingdom
facility: Freeman Hospital
Study officials:
References: