Phase
Condition
Cardiovascular Disease
Cardiac Disease
Heart Disease
Treatment
Placebo matching BI 765845
BI 765845
Clinical Study ID
Ages > 18 All Genders
Study Summary
Eligibility Criteria
Inclusion
Inclusion Criteria:
Age ≥18 years (or legal age as per local regulations) at the time of signinginformed consent
Signed and dated written informed consent in accordance with ICH Good ClinicalPractice (GCP) and local legislation prior to admission to the trial.
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 medicinl 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
Onset of symptoms of myocardial ischaemia or myocardial infarct, according topatient 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
Exclusion Criteria:
Women of childbearing potential
Patients indicated for rescue PCI (i.e. after receiving fibrinolysis)
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.
Known history of symptomatic heart failure (HF) with left ventricular systolicdysfunction (i.e. HFrEF) based on verbal medical history as reported by a trialparticipant or authorised representative
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 authorisedrepresentative)
Previous coronary artery bypass grafting (CABG) (based on verbal medical history asreported by a trial participant or authorised representative) Further exclusioncriteria apply.
Study Design
Connect with a study center
South Western Sydney Local Health District
Liverpool, New South Wales 2170
AustraliaSite Not Available
The Northern Hospital
Epping, Victoria 3076
AustraliaSite Not Available
University of Calgary
Calgary, Alberta T2N 2T9
CanadaActive - Recruiting
Hamilton General Hospital
Hamilton, Ontario L8L 2X2
CanadaSite Not Available
University of Ottawa Heart Institute
Ottawa, Ontario K1Y 4W7
CanadaSite Not Available
Centre Hospitalier de l'Universite de Montreal (CHUM)
Montreal, Quebec H2X 0C1
CanadaSite Not Available
Institut Universitaire de Cardiologie et de Pneumologie de Quebec (IUCPQ)
Québec, G1V 4G5
CanadaSite Not Available
IUCPQ (Laval University)
Québec 6325494, G1V 4G5
CanadaSite Not Available
St. Anna Hospital
Brno, 602 00
CzechiaSite Not Available
University Hospital Brno
Brno, 62500
CzechiaSite Not Available
University Hospital at St. Anna
Brno, 602 00
CzechiaSite Not Available
University Hospital Brno
Brno 3078610, 62500
CzechiaSite Not Available
University Hospital at St. Anna
Brno 3078610, 602 00
CzechiaSite Not Available
General University Hospital
Prague, 128 00
CzechiaSite Not Available
Charité - Universitätsmedizin Berlin
Berlin, 13353
GermanySite Not Available
Charite Universitätsmedizin Berlin KöR
Berlin 2950159, 13353
GermanySite Not Available
Städtisches Klinikum Dresden
Dresden, 01067
GermanySite Not Available
Universitätsklinikum Frankfurt
Frankfurt, 60590
GermanySite Not Available
Universitätsklinikum Freiburg
Freiburg, 79106
GermanyActive - Recruiting
Universitätsklinikum Freiburg
Freiburg im Breisgau, 79106
GermanySite Not Available
Medizinische Hochschule Hannover
Hanover, 30625
GermanySite Not Available
Asklepios Klinik Langen-Seligenstadt GmbH
Langen, 63225
GermanySite Not Available
Helios Herzzentrum Leipzig GmbH
Leipzig, 04289
GermanySite Not Available
Herzzentrum Leipzig GmbH
Leipzig, 04289
GermanyActive - Recruiting
Universität Leipzig
Leipzig, 04103
GermanySite Not Available
Universität Leipzig
Leipzig 2879139, 04103
GermanySite Not Available
Klinikum der Stadt Ludwigshafen am Rhein GmbH
Ludwigshafen, 67063
GermanySite Not Available
Klinikum der Stadt Ludwigshafen am Rhein gGmbH
Ludwigshafen, 67063
GermanyActive - Recruiting
Universitätsklinikum Ulm
Ulm, 89081
GermanySite Not Available
Semmelweis University
Budapest, 1122
HungarySite Not Available
University of Pecs
Pécs, 7624
HungarySite Not Available
Zala County Hospital, Zalaegerszeg
Zalaegerszeg, 8900
HungarySite Not Available
Ospedale "San Paolo"
Bari, 70124
ItalyActive - Recruiting
Ospedale San Paolo-Bari-18924
Bari, 70124
ItalySite Not Available
Azienda Ospedaliera Cannizzaro
Catania, 95126
ItalySite Not Available
Azienda Ospedaliera Universitaria Arcispedale Sant'Anna
Cona (FE), 44124
ItalySite Not Available
Osp. Pediatrico Aprano Pasquinucci
Massa, 54100
ItalyActive - Recruiting
Osp. Pediatrico Apuano Pasquinucci
Massa, 54100
ItalySite Not Available
A.O. San Gerardo di Monza
Monza, 20900
ItalySite Not Available
Azienda Ospedaliera Ospedali Riuniti Villa Sofia - Cervello
Palermo, 90146
ItalySite Not Available
Policlinico "Paolo Giaccone"
Palermo, 90127
ItalySite Not Available
Azienda Ospedaliera Universitaria Policlinico Paolo Giaccone
Palermo 2523920, 90127
ItalySite Not Available
AOU Policlinico Umberto I
Roma, 00161
ItalySite Not Available
AOU Policlinico Umberto I
Roma 8957247, 00161
ItalySite Not Available
Ospedale Mauriziano di Torino
Torino, 10128
ItalySite Not Available
Mito Medical Center
Ibaraki, Higashiibaraki-gun, 311-3193
JapanSite Not Available
National Hospital Organization Mito Medical Center
Ibaraki, Higashiibaraki-gun, 311-3193
JapanSite Not Available
Seoul National University Hospital
Seoul, 03080
Korea, Republic ofSite Not Available
Auckland City Hospital
Grafton / Auckland, 1023
New ZealandSite Not Available
American-Polish Heart Clinic, Lesser Poland Cardiovascular Centre
Chrzanów, 32-500
PolandSite Not Available
University Hospital in Krakow
Krakow, 30-688
PolandSite Not Available
Independent Public Health Care in Myszkow
Myszków, 42 300
PolandSite Not Available
University Clinical Hospital in Opole
Opole, 45-401
PolandSite Not Available
Independent Public Health Care Center of the Ministry of the Interior in Rzeszow
Rzeszów, 35-111
PolandSite Not Available
American Heart of Poland Sp. z o.o.-Tychy-44644
Tychy, 43-100
PolandSite Not Available
Changi General Hospital
Singapore, 529889
SingaporeSite Not Available
Khoo Teck Puat Hospital
Singapore, 768828
SingaporeSite Not Available
National Heart Center
Singapore, 169609
SingaporeActive - Recruiting
National Heart Centre Singapore
Singapore, 169609
SingaporeSite Not Available
National University Hospital-Singapore-42005
Singapore, 119074
SingaporeSite Not Available
Sengkang General Hospital
Singapore, 544886
SingaporeSite Not Available
Tan Tock Seng Hospital
Singapore, 308433
SingaporeSite Not Available
Changi General Hospital
Singapore 1880252, 529889
SingaporeSite Not Available
Khoo Teck Puat Hospital
Singapore 1880252, 768828
SingaporeSite Not Available
National Heart Centre Singapore
Singapore 1880252, 169609
SingaporeSite Not Available
National University Hospital-Singapore-42005
Singapore 1880252, 119074
SingaporeSite Not Available
Sengkang General Hospital
Singapore 1880252, 544886
SingaporeSite Not Available
Cardiovascular Diseases institute of Central Slovakia
Banská Bystrica, 97401
SlovakiaSite Not Available
National Institute of Cardiovascular Diseases
Bratislava, 831 01
SlovakiaSite Not Available
Cardiocenter Nitra, s.r.o
Nitra, 949 01
SlovakiaSite Not Available
Hanyang University Medical Center
Seoul, 04763
South KoreaSite Not Available
Seoul National University Hospital
Seoul 1835848, 03080
South KoreaSite Not Available
Hospital Santa Creu i Sant Pau
Barcelona, 08026
SpainSite Not Available
Hospital Universitari Vall d'Hebron
Barcelona, 08035
SpainSite Not Available
Hospital Vall d'Hebron
Barcelona, 08035
SpainActive - Recruiting
Hospital Santa Creu i Sant Pau
Barcelona 3128760, 08026
SpainSite Not Available
Hospital Vall d'Hebron
Barcelona 3128760, 08035
SpainActive - Recruiting
Hospital General Universitario Gregorio Marañón
Madrid, 28009
SpainSite Not Available
Hospital La Paz
Madrid, 28046
SpainActive - Recruiting
Hospital Universitario La Paz
Madrid, 28046
SpainSite Not Available
Hospital General Universitario Gregorio Marañón
Madrid 3117735, 28009
SpainSite Not Available
Hospital La Paz
Madrid 3117735, 28046
SpainActive - Recruiting
Hospital Universitario Virgen De La Macarena
Seville, 41009
SpainSite Not Available
Hospital Virgen Macarena
Seville 2510911, 41009
SpainSite Not Available
Complejo Hospitalario Universitario de Vigo
Vigo, 36312
SpainSite Not Available
NCKUH
Tainan, 704
TaiwanSite Not Available
National Taiwan University Hospital
Taipei, 100
TaiwanSite Not Available
Golden Jubilee National Hospital
Clydebank, G81 4DY
United KingdomSite Not Available
Leeds General Infirmary
Leeds, LS1 3EX
United KingdomSite Not Available
Freeman Hospital
Newcastle upon Tyne, NE7 7DN
United KingdomSite Not Available
Valley Clinical Trials, Inc.
Covina, California 91723
United StatesSite Not Available

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