Clinical trial NCT04957719: Selatogrel Outcome Study in Suspected Acute Myocardial Infarction
Official title: Multi-center, Double-blind, Randomized, Placebo-controlled, Parallel-group Study to Evaluate the Efficacy and Safety of Self-administered Subcutaneous Selatogrel for Prevention of All-cause Death and Treatment of Acute Myocardial Infarction in Subjects With a Recent History of Acute Myocardial Infarction
Study type: INTERVENTIONAL
Overall status: ENROLLING_BY_INVITATION
Phase: PHASE3
Conditions: Acute Myocardial Infarction
Keywords: Platelet Aggregation Inhibitors
Lead sponsor: Idorsia Pharmaceuticals Ltd.
Sponsor class: INDUSTRY
First posted: 2021-07-12
Enrollment: 14000
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 will randomize patients recently discharged from the hospital with a confirmed diagnosis of type 1 acute myocardial infarction (Thygesen et al. 2018) and having additional cardiovascular risk factors.

Detailed description: The purpose of this study is to assess the clinical efficacy of selatogrel when self-administered upon occurrence of symptoms suggestive of an acute myocardial infarction (AMI) in participants at risk of having a recurrent AMI.

Eligibility criteria: Main Inclusion Criteria:

* Confirmed diagnosis of symptomatic type 1 acute myocardial infarction (AMI) ST-Elevation Myocardial Infarction (STEMI) or Non-ST-Elevation Myocardial Infarction (NSTEMI), no longer than 4 weeks prior to randomization.
* Diagnosis of multivessel coronary artery disease defined as ≥ 50% stenosis on 2 or more coronary artery territories, including the left main artery, during a prior cardiac catheterization or cardiac catheterization during the qualifying AMI event and presence of at least 1 of the following risk factors:

  * Second prior AMI,
  * Diabetes mellitus defined by ongoing glucose lowering treatment,
  * Chronic kidney disease defined as estimated glomerular filtration rate less than 60 mL/min/1.73 m2 and either known history of chronic kidney disease or a biomarker of chronic kidney damage,
  * Peripheral artery disease at any time prior to randomization,
  * Absence of, or unsuccessful coronary revascularization of the qualifying AMI.
* Successful self-administered placebo according to the autoinjector instruction for use training during screening.

Main Exclusion Criteria:

* Increased risk of serious bleeding including any of the following:

  * History of intracranial bleed at any time.
  * Known uncorrected intracranial vascular abnormality.
  * Gastrointestinal bleed requiring hospitalization or transfusion within 1 year prior to screening.
  * Already on oral triple antithrombotic therapy (i.e., Dual antiplatelet therapy and oral anticoagulant).
  * Known liver impairment significantly affecting the hepatic function.
  * Current dialysis.
  * Ischemic stroke or transient ischemic attack within 3 months of screening.
* Chronic anemia with hemoglobin \< 10 g/dL.
* Chronic thrombocytopenia with platelet count \< 100,000/mm3.
* Known hypersensitivity to selatogrel, any of its excipients, or drugs of the P2Y12 class.
* Previous exposure to an investigational drug within 3 months prior to randomization.
* Participation in another clinical trial with an investigational product or device within 3 months prior to randomization.

Primary outcomes:
measure: Clinical status as assessed by a 6-point ordinal scale
timeFrame: Total duration: up to 7 days
measure: Occurrence of Type 3 or 5 treatment-emergent bleeding events according to the Bleeding Academic Research Consortium (BARC) definition
timeFrame: Total duration: up to 2 days
Secondary outcomes:
measure: Occurrence of death, non-fatal acute myocardial infarction, hospitalization or unplanned emergency department visit for heart failure (Composite endpoint)
timeFrame: Total duration: up to 30 days
Other outcomes:
Locations:
city: Alexander City
country: United States
facility: Advanced Cardiovascular, LLC
state: Alabama
city: Birmingham
country: United States
facility: Birmingham VA Health Care System
state: Alabama
city: Birmingham
country: United States
facility: University of Alabama at Birmingham
state: Alabama
city: Birmingham
country: United States
facility: Cardiovascular Associates of the Southeast
state: Alabama
city: Birmingham
country: United States
facility: Grandview Medical Center and Affinity Cardiovascular Specialists, LCC
state: Alabama
city: Huntsville
country: United States
facility: Heart Center Research, LLC
state: Alabama
city: Gilbert
country: United States
facility: Dignity Health Mercy Gilbert Medical Center
state: Arizona
city: Phoenix
country: United States
facility: Mayo Clinic Arizona
state: Arizona
city: Tucson
country: United States
facility: University of Arizona - Sarver Heart Center
state: Arizona
city: Jonesboro
country: United States
facility: Northeast Arkansas Charitable Foundation, Inc.- NEA Baptist Clinic
state: Arkansas
city: Concord
country: United States
facility: John Muir Health
state: California
city: Long Beach
country: United States
facility: Long Beach VA Healthcare System
state: California
city: San Francisco
country: United States
facility: San Francisco VA Health Care System"
state: California
city: Torrance
country: United States
facility: Lundquist Institute for Biomedical Innovation at Harbor - UCLA Medical Center
state: California
city: West Hills
country: United States
facility: Interventional Cardiology Medical Group
state: California
city: Golden
country: United States
facility: Colorado Heart and Vascular PC
state: Colorado
city: Littleton
country: United States
facility: South Denver Cardiology Associates, PC
state: Colorado
city: Newark
country: United States
facility: Christiana Care Health Services, Inc.
state: Delaware
city: Washington
country: United States
facility: MedStar Washington Hospital Center
state: District of Columbia
city: Brandon
country: United States
facility: Bay Area Cardiology Associates, P.A.
state: Florida
city: Clearwater
country: United States
facility: Clearwater Cardiovascular Consultants
state: Florida
city: Coral Gables
country: United States
facility: Pioneer Clinical Studies (PCS)
state: Florida
city: Jacksonville
country: United States
facility: University of Florida Health Science Center at Jacksonville
state: Florida
city: Jacksonville
country: United States
facility: Baptist Health Research Institute
state: Florida
city: Pensacola
country: United States
facility: Baptist Health Care, Inc. d/b/a Baptist Hospital Cardiology
state: Florida
city: Pensacola
country: United States
facility: Ascension Sacred Heart
state: Florida
city: Safety Harbor
country: United States
facility: Clearwater Cardiovascular Consultants
state: Florida
city: Decatur
country: United States
facility: Atlanta VA Medical Center
state: Georgia
city: Glenview
country: United States
facility: Endeavor Health
state: Illinois
city: Peoria
country: United States
facility: OSF HealthCare Cardiovascular Institute
state: Illinois
city: Indianapolis
country: United States
facility: Indiana University School of Medicine
state: Indiana
city: Muncie
country: United States
facility: Indiana University Health Ball Memorial Hospital
state: Indiana
city: Richmond
country: United States
facility: Reid Physician Associates
state: Indiana
city: Edgewood
country: United States
facility: St. Elizabeth Healthcare
state: Kentucky
city: Louisville
country: United States
facility: University of Louisville
state: Kentucky
city: Bossier City
country: United States
facility: Grace Research, LLC
state: Louisiana
city: Bangor
country: United States
facility: Northern Light Eastern Maine Medical Center
state: Maine
city: Baltimore
country: United States
facility: Sinai Hospital Baltimore, LifeBridge Health
state: Maryland
city: Silver Spring
country: United States
facility: Adventist Healthcare White Oak Medical Center
state: Maryland
city: Midland
country: United States
facility: MyMichigan Medical Center - Midland
state: Michigan
city: Saint Paul
country: United States
facility: Regions Hospital
state: Minnesota
city: Tupelo
country: United States
facility: Cardiology Associates Research
state: Mississippi
city: Columbia
country: United States
facility: University of Missouri Healthcare
state: Missouri
city: North Kansas City
country: United States
facility: North Kansas City Hospital
state: Missouri
city: Bridgewater
country: United States
facility: Advanced Heart Care, LLC
state: New Jersey
city: Newark
country: United States
facility: Saint Michael's Medical Center
state: New Jersey
city: Newark
country: United States
facility: Rutgers New Jersey Medical School
state: New Jersey
city: Pomona
country: United States
facility: AtlantiCare Regional Medical Center
state: New Jersey
city: Liverpool
country: United States
facility: St. Joseph's Hospital Cardiology
state: New York
city: New York
country: United States
facility: VA NY Harbor Healthcare System
state: New York
city: Durham
country: United States
facility: Duke University Medical Center
state: North Carolina
city: Greensboro
country: United States
facility: Moses H. Cone Memorial Hospital Operation Corporation d/b/a Cone Health
state: North Carolina
city: Cleveland
country: United States
facility: University Hospitals Cleveland Medical Center
state: Ohio
city: Oklahoma City
country: United States
facility: University of Oklahoma Health Sciences Center
state: Oklahoma
city: Chambersburg
country: United States
facility: Wellspan Chambersburg Hospital
state: Pennsylvania
city: Hershey
country: United States
facility: Penn State Health Milton S. Hershey Medical Center
state: Pennsylvania
city: Wyomissing
country: United States
facility: Penn State Health Medical Group - Berks Cardiology
state: Pennsylvania
city: Greenville
country: United States
facility: Prisma Health - Upstate
state: South Carolina
city: Greenville
country: United States
facility: Upstate Cardiology
state: South Carolina
city: Rapid City
country: United States
facility: Monument Health Clinical Research, Monument Health Rapid City Hospital Inc.
state: South Dakota
city: Chattanooga
country: United States
facility: CHI Institute for Research and Innovation
state: Tennessee
city: Memphis
country: United States
facility: Baptist Clinical Research Institute
state: Tennessee
city: Nashville
country: United States
facility: Vanderbilt University Medical Center
state: Tennessee
city: Oak Ridge
country: United States
facility: Covenant Medical Group d/b/a Parkway Cardiology Associates
state: Tennessee
city: Powell
country: United States
facility: Cardiovascular Research of Knoxville
state: Tennessee
city: Amarillo
country: United States
facility: Amarillo Heart Clinical Research Institute Inc.
state: Texas
city: Amarillo
country: United States
facility: PharmaTex Research
state: Texas
city: Charlottesville
country: United States
facility: UVA University Hospital
state: Virginia
city: Falls Church
country: United States
facility: Inova Heart & Vascular Institute
state: Virginia
city: Falls Church
country: United States
facility: Virginia Heart
state: Virginia
city: Richmond
country: United States
facility: Bon Secours St. Mary's Hospital of Richmond, LLC
state: Virginia
city: Milwaukee
country: United States
facility: Aurora St. Luke's Medical Center
state: Wisconsin
city: Chermside
country: Australia
facility: The Prince Charles Hospital
city: Concord
country: Australia
facility: Concord Repatriation General Hospital (CRGH) (Concord Hospital)
city: Epping
country: Australia
facility: The Cardiologists Pty. Ltd
city: Hobart
country: Australia
facility: Tasmanian Health at Royal Hobart Hospital
city: Milton
country: Australia
facility: Core Research Group Pty Ltd
city: St Albans
country: Australia
facility: Western Health - Sunshine Hospital
city: Wollongong
country: Australia
facility: Wollongong Hospital - Illawarra Shoalhaven Local Health District
city: Graz
country: Austria
facility: LKH Universitätsklinikum Graz
city: Klagenfurt
country: Austria
facility: Klinikum Klagenfurt am Woerthersse
city: Sankt Pölten
country: Austria
facility: Universitätsklinikum St. Pölten
city: Vienna
country: Austria
facility: Klinik Ottakring
city: Vienna
country: Austria
facility: Karl Landsteiner Institut für Kardiovaskuläre und Intensivmedizinische Forschung
city: Aalst
country: Belgium
facility: OLV Aalst
city: Genk
country: Belgium
facility: Hospital Oost-Limburg (ZOL)
city: Gent
country: Belgium
facility: AZ Sint-Lucas
city: Leuven
country: Belgium
facility: University Hospital Leuven (UZ Leuven)
city: Roeselare
country: Belgium
facility: AZ Delta Campus Rumbeke
city: Barretos
country: Brazil
facility: Hospital de Amor Barretos - Fundação PIO XII
city: Belo Horizonte
country: Brazil
facility: Santa Casa de Misericordia de Belo Horizonte
city: Belo Horizonte
country: Brazil
facility: CARDRESEARCH - Cardiologia Assistencial e de Pesquisa
city: Campina Grande do Sul
country: Brazil
facility: Sociedade Hospitalar Angelina Caron
city: Campinas
country: Brazil
facility: IPECC - Instituto de Pesquisa Clínica de Campinas
city: Juiz de Fora
country: Brazil
facility: Galileo Medical Research LTDA
city: Porto Alegre
country: Brazil
facility: Instituto de Cardiologia do Rio Grande do Sul/ Fundação Universitária de Cardiologia
city: Salvador
country: Brazil
facility: Hospital Santa Izabel - Santa Casa de Misericórdia da Bahia
city: São Paulo
country: Brazil
facility: Instituto do Coração do Hospital das Clínicas da Faculdade de Medicina da Universidade de São Paulo
city: Teresina
country: Brazil
facility: Centro de Pesquisa Cardiolima- Medicina e Saúde
city: Blagoevgrad
country: Bulgaria
facility: Mbal Puls
city: Burgas
country: Bulgaria
facility: UMHAT Deva Maria
city: Gotse Delchev
country: Bulgaria
facility: MHAT Ivan Skenderov EOOD
city: Kardzhali
country: Bulgaria
facility: Medical Centre Avitzena
city: Lovech
country: Bulgaria
facility: MHAT Cardiolife OOD
city: Pernik
country: Bulgaria
facility: SHATC Sveti Georgi
city: Sandanski
country: Bulgaria
facility: MHAT South-West Hospital, Cardiology Department
city: Sofia
country: Bulgaria
facility: UMHATEM N I Pirogov EAD
city: Calgary
country: Canada
facility: University of Calgary Foothills Medical Centre
state: Alberta
city: Edmonton
country: Canada
facility: Royal Alexandra Hospital
state: Alberta
city: Edmonton
country: Canada
facility: University of Alberta Hospital
state: Alberta
city: Edmonton
country: Canada
facility: Grey Nuns Community Hospital
state: Alberta
city: Halifax
country: Canada
facility: Queen Elizabeth II Health Sciences Centre
state: Nova Scotia
city: Brampton
country: Canada
facility: Wiliam Osler Health System
state: Ontario
city: Cambridge
country: Canada
facility: Cambridge Cardiac Care Center
state: Ontario
city: Newmarket
country: Canada
facility: York PCI Group, Inc.
state: Ontario
city: Peterborough
country: Canada
facility: Kawartha Cardiology Clinical Trials
state: Ontario
city: Toronto
country: Canada
facility: St. Michael's Hospital
state: Ontario
city: Lévis
country: Canada
facility: Clinique de Cardiologie de Lévis
state: Quebec
city: Montréal
country: Canada
facility: Montreal Heart Institute
state: Quebec
city: Montréal
country: Canada
facility: CHUM - Centre hospitalier de l'Universite de Montreal"
state: Quebec
city: Montréal
country: Canada
facility: Hôpital du Sacré-Coeur de Montréal
state: Quebec
city: Trois-Rivières
country: Canada
facility: Centre Intégré universitaire de santé et de services sociaux de la Mauricie-et-du-Centre-du-Québec
state: Quebec
city: Montréal
country: Canada
facility: Hôpital du Sacré-Coeur de Montréal
city: Ottawa
country: Canada
facility: University of Ottawa Heart Institute
city: Trois-Rivieres
country: Canada
facility: Diex Research, Inc.
city: Santiago
country: Chile
facility: Cec-Suecia
city: Santiago
country: Chile
facility: Pontificia Universidad Catolica de Chile
city: Santiago
country: Chile
facility: Clinica Ensenada
city: Victoria
country: Chile
facility: Hospital San Jose de Victoria
city: Beijing
country: China
facility: Beijing Anzhen Hospital, Capital Medical University
city: Beijing
country: China
facility: Beijing Luhe Hospital, Capital Medical University
city: Beijing
country: China
facility: Beijing Pinggu Hospital
city: Changchun
country: China
facility: The First Bethune Hospital of Jilin University
city: Changchun
country: China
facility: The Second Hospital of Jilin University
city: Changsha
country: China
facility: Xiangya Hospital Central South University
city: Changsha
country: China
facility: The Second Xiangya Hospital of Central South University
city: Changsha
country: China
facility: The Third Xiangya Hospital of Central South University
city: Chengdu
country: China
facility: West China Hospital of Sichuan University
city: Dalian
country: China
facility: The Second Hospital of Dalian Medical University
city: Daqing
country: China
facility: Daqing Oilfield General hospital
city: Dongcheng
country: China
facility: Beijing Hospital
city: Fuzhou
country: China
facility: Fujian Provincial Hospital
city: Guangdong
country: China
facility: The First Affiliated Hospital of Shantou University Medical College
city: Guangzhou
country: China
facility: Guangdong Provincial People's Hospital
city: Hangzhou
country: China
facility: The First Affiliated Hospital, Zhejiang University School of Medicine
city: Hangzhou
country: China
facility: Sir Run Run Shaw Hospital (SRRSH), affiliated with the Zhejiang University School of Medicine
city: Hangzhou
country: China
facility: The second Affiliated Hospital of Zhejiang University School of Medicine
city: Hefei
country: China
facility: The First Affiliated Hospital of USTC(Anhui Provincial Hospital)
city: Jinan
country: China
facility: Shandong University Qilu Hospital
city: Jinan
country: China
facility: The First Affiliated Hospital of Shandong First Medical University (Shandong Provincial Qianfoshan Hospital)
city: Jinan
country: China
facility: The Second Hospital of Shandong University
city: Jining
country: China
facility: Jining No.1 People's Hospital
city: Lianyungang
country: China
facility: Lianyungang First People's Hospital
city: Liaocheng
country: China
facility: Liaocheng people's Hospital
city: Linyi
country: China
facility: Linyi People's Hospital
city: Nanchang
country: China
facility: The Second Affiliated Hospital of Nanchang University
city: Nanchong
country: China
facility: Beijing Anzhen Nanchong Hospital, Capital Medical University & Nanchong Central Hospital
city: Nanjing
country: China
facility: Nanjing Drum Tower Hospital
city: Nanjing
country: China
facility: Zhongda Hospital Southeast University
city: Nanjing
country: China
facility: Nanjing Jiangning Hospital
city: Nanyang
country: China
facility: Nanyang Central Hospital
city: Nanyang
country: China
facility: Nanyang Second People's Hospital
city: Pingxiang
country: China
facility: Pingxiang People's Hospital
city: Qingdao
country: China
facility: Qingdao Municipal Hospital
city: Shanghai
country: China
facility: Shanghai Ninth People's hospital, Shanghai Jiaotong University School of Medicine
city: Shanghai
country: China
facility: Shanghai Chest Hospital ,Shanghai Jiao Tong University School of Medicine
city: Shanghai
country: China
facility: Shanghai General Hospital
city: Shanghai
country: China
facility: Renji Hospital, Shanghai Jiaotong University School of Medicine
city: Shaoxing
country: China
facility: Zhuji People's Hospital
city: Shenyang
country: China
facility: The People's Hospital of Liaoning Province
city: Shijiazhuang
country: China
facility: The Third Hospital of Shijiazhuang
city: Shijiazhuang
country: China
facility: The Second Hospital of Hebei Medical University
city: Taiyuan
country: China
facility: Shanxi Cardiovascular Hospital
city: Tangshan
country: China
facility: Tangshan Central Hospital
city: Tianjin
country: China
facility: Tianjin Medical University General Hospital
city: Tianjin
country: China
facility: Tianjin Chest Hospital
city: Tianjin
country: China
facility: Teda International Cardiovascular Hospital
city: Wuhan
country: China
facility: The Central Hospital of Wuhan
city: Wuhan
country: China
facility: Wuhan Asia Heart Hospital
city: Wuhan
country: China
facility: Renmin Hospital of Wuhan University
city: Xi'an
country: China
facility: The First Affiliated Hospital of Xi'an Jiaotong University
city: Xinxiang
country: China
facility: Xinxiang Central Hospital
city: YangZhou
country: China
facility: Northern Jiangsu People's Hospital
city: Yiyang
country: China
facility: Yiyang Central Hospital
city: Zhengzhou
country: China
facility: The 7th People's Hospital of Zhengzhou
city: Zhengzhou
country: China
facility: The First Affiliated Hospital of Zhengzhou University
city: Zibo
country: China
facility: Zibo Central Hospital
city: Armenia
country: Colombia
facility: Cardiomet Cequin S.A.S
city: Bogota
country: Colombia
facility: Administradora Country S.A.S. - Clinica del Country
city: Bogotá
country: Colombia
facility: Hospital Universitario San Ignacio
city: Bogotá
country: Colombia
facility: Fundación Cardioinfantil - Instituto de Cardiología
city: Cali
country: Colombia
facility: Fundación Valle del Lili
city: Cali
country: Colombia
facility: IPS Centro Médico Julián Coronel S.A.S
city: Cali
country: Colombia
facility: Clinica Imbanaco S.A.S
city: Floridablanca
country: Colombia
facility: Fundación cardiovascular de Colombia
city: Medellin
country: Colombia
facility: Hospital Alma Mater de Antioquia
city: Medellin
country: Colombia
facility: Rodrigo Botero SAS
city: Medellín
country: Colombia
facility: Clinica Cardio VID
city: Brno
country: Czechia
facility: University Hospital Brno
city: Brno
country: Czechia
facility: ICRC St. Anne University Hospital
city: Hradec Kralove
country: Czechia
facility: University hospital Hradec Králové
city: Jihlava
country: Czechia
facility: Regional Hospital Jihlava
city: Liberec
country: Czechia
facility: Regional Hospital Liberec
city: Pardubice
country: Czechia
facility: Nemocnice Pardubickeho kraje, a.s. - Pardubicka nemocnice
city: Pilsen
country: Czechia
facility: Fakultní nemocnice Plzen
city: Prague 10
country: Czechia
facility: Kardiologie Praha s.r.o.
city: Prague 2
country: Czechia
facility: General Faculty Hospital
city: Prague 4
country: Czechia
facility: Institutu Klinicke a Experimentalni Mediciny (IKEM) (Institute for Clinical and Experimental Medicine)
city: Prague
country: Czechia
facility: Univ. Hospital Vinohrady
city: Praha 1 - Nové Mesto
country: Czechia
facility: Kardiologie Vinohrady s.r.o.
city: Praha
country: Czechia
facility: Všeobecná fakultní nemocnice
city: Prostějov
country: Czechia
facility: Olomuc Cardiology
city: Ústí Nad Labem
country: Czechia
facility: University Hospital Ústí nad Labem
city: České Budějovice
country: Czechia
facility: Regional Hospital Ceské Budejovice
city: Aalborg
country: Denmark
facility: Aalborg University Hospital Cardiology
city: Aarhus
country: Denmark
facility: Aarhus University Hospital
city: Esbjerg
country: Denmark
facility: Esbjerg Hospital
city: Hellerup
country: Denmark
facility: Rigshospitalet
city: Herning
country: Denmark
facility: Goedstrup Region Hospital
city: Herning
country: Denmark
facility: Herning Hospital
city: Odense
country: Denmark
facility: Odense Universitetshospital
city: Roskilde
country: Denmark
facility: Zealand University Hospital
city: Svendborg
country: Denmark
facility: Svendborg Hospital
city: Viborg
country: Denmark
facility: Viborg Hospital
city: Tallinn
country: Estonia
facility: The North Estonia Medical Centre
city: Tartu
country: Estonia
facility: Heart Clinic, Tartu University Hospital
city: Espoo
country: Finland
facility: Jorvi Hospital, Helsinki University Hospital
city: Helsinki
country: Finland
facility: Heart and Lung Center, Helsinki University Hospital
city: Joensuu
country: Finland
facility: North Karelian Central Hospital
city: Jyväskylä
country: Finland
facility: StudyCor
city: Kokkola
country: Finland
facility: Kokkola Central Hospital
city: Kuopio
country: Finland
facility: Kuopio University Hospital
city: Oulu
country: Finland
facility: Oulu University Hospital
city: Seinäjoki
country: Finland
facility: Seinäjoki Central Hospital
city: Tampere
country: Finland
facility: TAYS Tutkimusvastaanotto / TAYS Research Center
city: Turku
country: Finland
facility: Heart Center, Turku University Hospital
city: Pessac
country: France
facility: Hopital Cardiologique CHU Bordeaux
state: Gironde
city: Brest
country: France
facility: CHRU Brest - Cavale Blanche
city: Caen
country: France
facility: CHU Caen · Unité Cardiologie et Pathologie Vasculaire
city: La Roche-sur-Yon
country: France
facility: Hospital Center Departmental Vendée
city: Le Coudray
country: France
facility: CH Chartres
city: Marseille
country: France
facility: CHU Timone 2
city: Montpellier
country: France
facility: Hôpital Arnaud de Villeneuve
city: Montpellier
country: France
facility: Clinique du Millénaire
city: Nîmes
country: France
facility: Univ Hosp de Nimes Carémeau
city: Paris
country: France
facility: University Hospitals Pitié Salpêtrière
city: Paris
country: France
facility: Bichat-Claude Bernard Hospital
city: Strasbourg
country: France
facility: Nouvel Hopital Civil
city: Toulouse
country: France
facility: Hosp Rangueil - Cardiology A Dept
city: Vandœuvre-lès-Nancy
country: France
facility: CHRU Nancy
city: Tbilisi
country: Georgia
facility: Aleksandere Aladashvili Clinic
city: Tbilisi
country: Georgia
facility: Acad. G. Chapidze Emergency Cardiology Center
city: Tbilisi
country: Georgia
facility: Bokhua Memorial CardioVascular Center
city: Tbilisi
country: Georgia
facility: Tbilisi Heart and Vascular Clinic Ltd.
city: Tbilisi
country: Georgia
facility: TIM Hospital
city: Tbilisi
country: Georgia
facility: LTD "Tbilisi Heart Center"
city: Bad Krozingen
country: Germany
facility: Universitätsklinikum Freiburg; Universitäts-Herzzentrum Freiburg-Bad Krozingen
city: Bad Oeynhausen
country: Germany
facility: Herz- und Diabeteszentrum NRW
city: Berlin
country: Germany
facility: MedicTRials STUG - Praxis Dr. Toursarkissian
city: Berlin
country: Germany
facility: Vivantes Netzwerk für Gesundheit GmbH
city: Berlin
country: Germany
facility: Vivantes Klinikum Spandau
city: Dortmund
country: Germany
facility: St. Johannes Hospital Dortmund
city: Dresden
country: Germany
facility: Herzzentrum Dresden GmbH; Universitätsklinik an der Technischen Universität Dresden
city: Hamburg
country: Germany
facility: Universitätsklinikum Hamburg Eppendorf
city: Karlsbad
country: Germany
facility: SRH Klinikum Karlsbad-Langensteinbach GmbH
city: Köln
country: Germany
facility: Krankenhaus der Augustinerinnen Köln gGmbH
city: Köln
country: Germany
facility: Universitätsklinikum Köln
city: Leipzig
country: Germany
facility: Herzzentrum Leipzig GmbH
city: Ludwigshafen
country: Germany
facility: Gesellschaft für Klinische Forschung mbH Ludwigshafen
city: Magdeburg
country: Germany
facility: Uniklinikum Magdeburg A. ö. R.
city: Mannheim
country: Germany
facility: Universitätsmedizin Mannheim
city: München
country: Germany
facility: München Klinik Neuperlach
city: Regensburg
country: Germany
facility: Studienzentrum Innere Med. II Kardiologie, Universitätsklinikum Regensburg
city: Stuttgart
country: Germany
facility: Robert-Bosch Krankenhaus Stuttgart
city: Trier
country: Germany
facility: Krankenhaus der Barmherzigen Brüder
city: Tübingen
country: Germany
facility: Universitätsklinikum Tübingen, Medizinische Klinik Innere Medizin III Kardiologie und Angiologie
city: Völklingen
country: Germany
facility: Siteworks GmbH Prüfzentrum Völklingen
city: Wuppertal
country: Germany
facility: Helios Universitätsklinikum Wuppertal
city: Alexandroupolis
country: Greece
facility: University General Hospital of Alexandroupolis
city: Athens
country: Greece
facility: Ippokrateio (Hyppokration) General Hospital of Athens
city: Athens
country: Greece
facility: University General Hospital "Attikon"
city: Heraklion
country: Greece
facility: University Hospital of Heraklion
city: Magoula
country: Greece
facility: Thriasio General Hospital
city: Marousi
country: Greece
facility: Sismanoglio Hospital of GNA "Sismanoglio - Amalia Fleming
city: Nea Ionia
country: Greece
facility: Konstantopouleio - Patision General Hospital of Nea Ionia
city: Patras
country: Greece
facility: University Hospital of Patras
city: Thessaloníki
country: Greece
facility: Aristotle University of Thessaloniki (AUTH) - University General Hospital of Thessaloniki (AHEPA)
city: Thessaloníki
country: Greece
facility: General Hospital of Thessaloniki G.Papanikolaou
city: Voula
country: Greece
facility: Asklepeion General Hospital, Voula
city: Balatonfüred
country: Hungary
facility: Állami Szívkorhaz
city: Budapest
country: Hungary
facility: Betegápoló Irgalmasrend Budai Irgalmasrendi Kórház, Kardiológia
city: Budapest
country: Hungary
facility: Gottsegen György Országos Kardiovaszkuláris Intézet
city: Budapest
country: Hungary
facility: Budapesti Bajcsy-Zsilinszky Hospital
city: Budapest
country: Hungary
facility: Semmelweis Egyetem Városmajori Szív- és Érgyógyászati Klinika Kardiológia
city: Budapest
country: Hungary
facility: Magyar Honvédség Egészségügyi Központ
city: Budapest
country: Hungary
facility: Uzsoki Utcai Kórház
city: Debrecen
country: Hungary
facility: Debreceni Egyetem Klinikai Központ Kardiológiai és Szívsebészeti Klinika
city: Kecskemét
country: Hungary
facility: Bács-Kiskun Megyei Kórház a Szegedi Tudományegyetem Általános Orvostudományi Kar Oktató Kórháza
city: Nyíregyháza
country: Hungary
facility: SzSzBV Egyetemi Oktatókórház, Nyíregyházi Jósa András Tagkórház, Kardiológia
city: Szeged
country: Hungary
facility: Szegedi Tudományegyetem ÁOK Szent-Györgyi Albert Klinikai Központ II.sz. Belgyógyászati Klinika és Kardiológiai Központ
city: Szolnok
country: Hungary
facility: Jász-Nagykun-Szolnok Megyei Hetényi Géza Kórház-Rendelőintézet
city: Zalaegerszeg
country: Hungary
facility: Léda-Platán Magánklinika
city: Beer-Sheva
country: Israel
facility: Soroka University Medical Center
city: Hadera
country: Israel
facility: Hillel Yaffee Medical Center, Cardiology Department
city: Haifa
country: Israel
facility: Rambam Health Care Campus
city: Haifa
country: Israel
facility: Bnai Zion Medical Center, Cardiology
city: H̱olon
country: Israel
facility: Edith Wolfson Medical Center
city: Jerusalem
country: Israel
facility: Shaare Zedek Medical Center, Cardiology Department
city: Jerusalem
country: Israel
facility: Hadassah Hospital on Mount Scopus
city: Kfar Sava
country: Israel
facility: Meir Medical Center
city: Nahariya
country: Israel
facility: Galilee Medical Center
city: Petah tikva
country: Israel
facility: Rabin Medical Center
city: Rehovot
country: Israel
facility: Kaplan Medical Center, Intensive Cardiac Care Unit
city: Tel Aviv
country: Israel
facility: Tel-Aviv Sourasky Medical Center
city: Tel Hashomer
country: Israel
facility: Leviev Heart Center, Sheba Medical Center
city: Zefat
country: Israel
facility: Ziv Medical Center
city: Zerifin
country: Israel
facility: Shamir Medical Center (Assaf Harofeh)
city: Arezzo
country: Italy
facility: San Donato Hospital, U.O.C. Cardiology
city: Bologna
country: Italy
facility: Ospedale Maggiore Bologna - Dept. Cardiology
city: Caserta
country: Italy
facility: AORN "Sant'Anna e San Sebastiano"
city: Catania
country: Italy
facility: Azienda Ospedaliero-Universitaria Policlinico ""G. Rodolico - San Marco
city: Catania
country: Italy
facility: Azienda Ospedaliero-Universitaria Policlinico "G. Rodolico - San Marco"
city: Catanzaro
country: Italy
facility: AOU Mater Domini
city: Cona
country: Italy
facility: University Hospital of Ferrara, Cardiology Unit
city: Firenze
country: Italy
facility: "SOD Cardiologia Interventistica Strutturale, AOU Careggi
city: Messina
country: Italy
facility: A.O.U. Policlinico Gaetano Martino
city: Napoli
country: Italy
facility: University of Naples "Federico II"
city: Orbassano
country: Italy
facility: AOU San Luigi Gonzaga Hospital
city: Perugia
country: Italy
facility: Azienda Ospedaliera di Perugia
city: Perugia
country: Italy
facility: Azienda Ospedaliera di Perugia
city: Torino
country: Italy
facility: A.O.U.Città della Salute e della Scienza di Torino
city: Trento
country: Italy
facility: Cardiology Department - Santa Chiara Hospital
city: Trento
country: Italy
facility: Cardiology Department - Santa Chiara Hospital
city: Turin
country: Italy
facility: Infermi Hospital in Rivoli (Turin)
city: Kaunas
country: Lithuania
facility: Hospital of Lithuanian University of Health Sciences Kauno Klinikos
city: Klaipeda
country: Lithuania
facility: Klaipeda Seamen's Hospital
city: Panevezys
country: Lithuania
facility: Republican Panevezys Hospital
city: Vilnius
country: Lithuania
facility: Vilnius University Hospital Santaros Klinikos
city: Aguascalientes
country: Mexico
facility: Hospital Cardiológica Aguascalientes
city: Ciudad de Mexico
country: Mexico
facility: Boca Clinical Trials México, SC (CDMX)
city: Culiacán
country: Mexico
facility: Centro para el desarrollo de la medicina y de asistencia médica especializada S.C.
city: Mexico City
country: Mexico
facility: Instituto Nacional de Cardiología "Ignacio Chávez"
city: Mexico City
country: Mexico
facility: Fundación de Atención e Investigación Médica Lindavista S.C
city: Puebla
country: Mexico
facility: Boca Clinical Trials México, SC (Puebla)
city: Queretaro
country: Mexico
facility: SMIQ / Boca Clinical Trials México
city: San Luis Potosí
country: Mexico
facility: Centro de Atención e Investigación Cardiovascular del Potosí, S.C.
city: San Luis Potosí
country: Mexico
facility: Centro Potosino de Investigación Médica S.C.
city: 's-Hertogenbosch
country: Netherlands
facility: Jeroen Bosch Ziekenhuis
city: Alkmaar
country: Netherlands
facility: Noordwest Ziekenhuisgroep
city: Amersfoort
country: Netherlands
facility: Meander Medisch Centrum
city: Amsterdam
country: Netherlands
facility: Onze Lieve Vrouwe Gasthuis, locatie Oost
city: Amsterdam
country: Netherlands
facility: Amsterdam UMC
city: Apeldoorn
country: Netherlands
facility: Gelre Ziekenhuis Apeldoorn
city: Deventer
country: Netherlands
facility: Deventer Ziekenhuis
city: Dordrecht
country: Netherlands
facility: Albert Schweitzer Ziekenhuis
city: Ede
country: Netherlands
facility: Gelderse Vallei Ziekenhuis
city: Eindhoven
country: Netherlands
facility: Catharina Hospital
city: Groningen
country: Netherlands
facility: UMC Groningen
city: Heerlen
country: Netherlands
facility: Zuyderland Medical Center
city: Hoorn
country: Netherlands
facility: Vasculair Onderzoek Centrum Hoorn
city: Leeuwarden
country: Netherlands
facility: Medisch Centrum Leeuwarden
city: Nijmegen
country: Netherlands
facility: Radboud UMC
city: Nijmegen
country: Netherlands
facility: Canisius-Wilhelmina Ziekenhuis
city: Roosendaal
country: Netherlands
facility: Bravis Ziekenhuis
city: Tiel
country: Netherlands
facility: Ziekenhuis Rivierenland
city: Tilburg
country: Netherlands
facility: Elisabeth-TweeSteden Ziekenhuis
city: Utrecht
country: Netherlands
facility: Diakonessenhuis Utrecht
city: Veldhoven
country: Netherlands
facility: Máxima Medisch Centrum
city: Hamilton
country: New Zealand
facility: Waikato Hospital
city: New Plymouth
country: New Zealand
facility: Taranaki Base Hospital
city: Lørenskog
country: Norway
facility: Akershus University Hospital
city: Oslo
country: Norway
facility: Diakonhjemmet Hospital
city: Oslo
country: Norway
facility: Oslo University Hospital Rikshospitalet
city: Oslo
country: Norway
facility: Oslo University Hospital, Ullevål hospital
city: Sarpsborg
country: Norway
facility: Sykehuset Østfold Kalnes (Trust)
city: Tønsberg
country: Norway
facility: Vestfold Hospital
city: Białystok
country: Poland
facility: Invasive Cardiology Department, University Teaching Hospital in Białystok
city: Bydgoszcz
country: Poland
facility: Specjalistyczna Praktyka Lekarska Paweł Grzelakowski Centrum Kardiologii Paewł Grzelakowski
city: Gdansk
country: Poland
facility: Uniwersyteckie Centrum Kliniczne
city: Katowice
country: Poland
facility: Górnośląskie Centrum Medyczne w Katowicach, III Oddział Kardiologii
city: Kraków
country: Poland
facility: Szpital Uniwersytecki w Krakowie, Oddział Kliniczny Kardiologii oraz Interwencji Sercowo-Naczyniowych
city: Lublin
country: Poland
facility: Miedziowe Centrum Zdrowia Regionalny, Ośrodek Kardiologiczny, Pracownia Angiografii i Hemodynamiki
city: Lódz
country: Poland
facility: Wojewodzki Szpital Specj im.W Bieganskiego
city: Olsztyn
country: Poland
facility: Wojewódzki Szpital Specjalistyczny w Olsztynie, Oddział Kardiologii
city: Poznan
country: Poland
facility: INKARD Sp. Z O.O. Sp. JAWNA
city: Poznań
country: Poland
facility: Szpital Kliniczny im. Heliodora Swiecickiego Uniwersytetu Medycznego im. Karola Marcinkowskiego w Poznaniu
city: Toruń
country: Poland
facility: Oddzial Kardiologii i intensywnej Terapii Kardiologicznej
city: Warsaw
country: Poland
facility: Pracownia Kardiologii Inwazyjnej I Katedry i Kliniki Kardiologii Uniwersyteckiego Centrum Klinicznego Warszawskiego Uniwersytetu Medycznego
city: Warsaw
country: Poland
facility: Narodowy Instytut Kardiologii
city: Wloclawek
country: Poland
facility: The Provincial Specialist Hospital in Wloclawek
city: Wroclaw
country: Poland
facility: T.Marciniak Hosp
city: Wrocław
country: Poland
facility: Uniwersytecki Szpital Kliniczny we Wroclawiu
city: Zabrze
country: Poland
facility: SCCS Zabrze I i II Oddział Kardiologii i Angiologii
city: Łódź
country: Poland
facility: Nzoz Salusmed Jan Zbigniew Peruga Pphu Salus Poradnia Kardiologiczna
city: Almada
country: Portugal
facility: Unidade Local de Saúde de Almada-Seixal, E.P.E.
city: Aveiro
country: Portugal
facility: Unidade Local de Saúde da Região de Aveiro, E.P.E.
city: Coimbra
country: Portugal
facility: Unidade Local de Saude de Coimbra EPE
city: Leiria
country: Portugal
facility: Unidade Local de Saúde da Região de Leiria, E.P.E.
city: Lisboa
country: Portugal
facility: Unidade Local de Saúde de Santa Maria, E.P.E.
city: Baia Mare
country: Romania
facility: Spitalul Judetean de Urgenta ""Dr. Constantin Opris" Baia Mare
city: Baia Mare
country: Romania
facility: Spitalul Judetean de Urgenta "Dr. Constantin Opris" Baia Mare
city: Braşov
country: Romania
facility: County Clinical Emergency Hospital Brasov
city: Bucharest
country: Romania
facility: Spitalul Clinic de Urgenta Bucuresti
city: Bucharest
country: Romania
facility: Spitalul Clinic de Urgenta Bucuresti
city: Cluj-Napoca
country: Romania
facility: Institutul Inimii de Urgență pentru Boli Cardiovasculare "Niculae Stăncioiu"
city: Cluj-Napoca
country: Romania
facility: Spitalul Clinic Judetean de Urgenta Cluj Napoca
city: Satu Mare
country: Romania
facility: Spitalul Judetean de Urgenta Satu Mare
city: Targu Mures
country: Romania
facility: County Clinical Emergency Hospital Targu Mures
city: Timişoara
country: Romania
facility: Institute of Cardiovascular Diseases Timisoara
city: Belgrade
country: Serbia
facility: Kliničko bolnički centar "Zvezdara"
city: Belgrade
country: Serbia
facility: University Clinical Center of Serbia (Department for Cardiovascular Disease Cardiology Clinic)
city: Belgrade
country: Serbia
facility: University Clinical Center of Serbia (Diagnostic and Catheterization Lab)
city: Belgrade
country: Serbia
facility: University Clinical Center of Serbia (Emergency Cardiology Services)
city: Belgrade
country: Serbia
facility: University Clinical Center of Serbia
city: Belgrade
country: Serbia
facility: University Hospital Centre Dr Dragiša Mišovic - Dedinje
city: Belgrade
country: Serbia
facility: Dedinje Cardiovascular Institute
city: Belgrade
country: Serbia
facility: Clin Hosp Ctr Zemun - Cardiology Dept
city: Belgrade
country: Serbia
facility: Department of Cardiology, Clinical Hospital Center Zemun
city: Belgrade
country: Serbia
facility: Klinicko bolnicki centar, Bežanijska kosa
city: Belgrade
country: Serbia
facility: Kliničko Bolnički Centar Bežanijska Kosa
city: Kragujevac
country: Serbia
facility: Klinički centar Kragujevac
city: Leskovac
country: Serbia
facility: Opšta bolnica Leskovac
city: Niš
country: Serbia
facility: Klinički Centar Niš
city: Sremska Kamenica
country: Serbia
facility: Institute of Cardiovascular Diseases, Vojvodina
city: Užice
country: Serbia
facility: Opšta bolnica Užice
city: Zaječar
country: Serbia
facility: Zdravstveni Centar Zajecar
city: Banska Bystrica
country: Slovakia
facility: Central Slovak Institute of Cardiovascular Diseases
city: Bratislava
country: Slovakia
facility: Premedix Clinic
city: Bratislava
country: Slovakia
facility: University Hospital Bratislava
city: Bratislava
country: Slovakia
facility: Cardiocentre CINRE
city: Košice
country: Slovakia
facility: Východoslovenský ústav srdcových a cievnych chorôb
city: Nitra
country: Slovakia
facility: Kardiocentrum Nitra
city: Badalona
country: Spain
facility: Hospital Universitari Germans Trias i Pujol
city: Barcelona
country: Spain
facility: Hospital de La Santa Creu I Sant Pau
city: Barcelona
country: Spain
facility: Hospital Clinic. Barcelona
city: El Palmar
country: Spain
facility: Hospital Universitario Virgen de la Arrixaca
city: L'Hospitalet De Llobregat
country: Spain
facility: Hospital Universitari de Bellvitge
city: Madrid
country: Spain
facility: Hospital Universitario de la Princesa
city: Madrid
country: Spain
facility: Hospital Clinico San Carlos
city: Málaga
country: Spain
facility: Hospital Universitario Virgen de la Victoria
city: Santiago De Compostela
country: Spain
facility: Hospital Clinico Universitario de Santiago
city: Valencia
country: Spain
facility: Hospital Clinico Valencia
city: Vigo
country: Spain
facility: Hospital Alvaro Cunqueiro, Cardiovascular Unit
city: Basel
country: Switzerland
facility: Universitätsspital Basel; Universitäres Herzzentrum
city: Bern
country: Switzerland
facility: Inselspital, Universitäatspital Bern, Universitäatklinik für Kardiologie
city: Lugano
country: Switzerland
facility: Istituto Cardiocentro Ticino
city: Saint Gallen
country: Switzerland
facility: HOCH Health Ostschweiz, Kantonsspital St. Gallen
city: Kaohsiung City
country: Taiwan
facility: Kaohsiung Medical University Chung-Ho Memorial Hospital
city: Kaohsiung
country: Taiwan
facility: Chang Gung Medical Foundation-Kaohsiung
city: New Taipei City
country: Taiwan
facility: Mackay Memorial Hospital Tamsui
city: Tainan City
country: Taiwan
facility: Chi Mei Medical Center
city: Bangkok
country: Thailand
facility: Siriraj Hospital
city: Phitsanulok
country: Thailand
facility: Buddhachinaraj Phitsanulok Hospital
city: Songkhla
country: Thailand
facility: Songklanagarind Hospital
city: Cambridge
country: United Kingdom
facility: Royal Papworth Hospital NHS Foundation Trust
city: Londonderry
country: United Kingdom
facility: Altnagelvin Area Hospital (WHSCT)
city: Newcastle
country: United Kingdom
facility: Freeman Hospital
city: North Shields
country: United Kingdom
facility: North Tyneside General Hospital, Northumbria Healthcare
city: Portadown
country: United Kingdom
facility: Southern Health & Social Care Trust
city: Sheffield
country: United Kingdom
facility: Northern General Hospital
city: Stevenage
country: United Kingdom
facility: Lister Hospital East and North Hertfordshire NHS Trust
Study officials:
affiliation: Idorsia Pharmaceuticals Ltd.
name: Clinical Trials
role: STUDY_DIRECTOR
References:
citation: Thygesen K, Alpert JS, Jaffe AS, Chaitman BR, Bax JJ, Morrow DA, White HD; Executive Group on behalf of the Joint European Society of Cardiology (ESC)/American College of Cardiology (ACC)/American Heart Association (AHA)/World Heart Federation (WHF) Task Force for the Universal Definition of Myocardial Infarction. Fourth Universal Definition of Myocardial Infarction (2018). J Am Coll Cardiol. 2018 Oct 30;72(18):2231-2264. doi: 10.1016/j.jacc.2018.08.1038. Epub 2018 Aug 25. No abstract available.
citation: Mehran R, Rao SV, Bhatt DL, Gibson CM, Caixeta A, Eikelboom J, Kaul S, Wiviott SD, Menon V, Nikolsky E, Serebruany V, Valgimigli M, Vranckx P, Taggart D, Sabik JF, Cutlip DE, Krucoff MW, Ohman EM, Steg PG, White H. Standardized bleeding definitions for cardiovascular clinical trials: a consensus report from the Bleeding Academic Research Consortium. Circulation. 2011 Jun 14;123(23):2736-47. doi: 10.1161/CIRCULATIONAHA.110.009449. No abstract available.