Back to resultsSelatogrel Outcome Study in Suspected Acute Myocardial Infarction (SOS-AMI)
Primary Purpose
Acute Myocardial Infarction
Status
Enrolling by invitation
Phase
Phase 3
Locations
International
Study Type
Interventional
Intervention
Selatogrel
Placebo
Sponsored by
About this trial
This is an interventional treatment trial for Acute Myocardial Infarction focused on measuring Platelet Aggregation Inhibitors
Eligibility Criteria
Main Inclusion Criteria:
- Discharged with a 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.
Presence of either a second prior AMI within 1 year of screening or at least 2 of the following risk factors:
- Second prior AMI more than 1 year before screening.
- Diabetes mellitus defined by ongoing glucose lowering treatment.
- Chronic kidney disease with estimated glomerular filtration rate less-than 60 mL/min/1.73 m2.
- Multivessel coronary artery disease.
- Peripheral artery disease.
- Age greater than or equal to 65 years.
- Absence of coronary revascularization of the qualifying AMI.
- Active daily smoking at screening.
- 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.
Sites / Locations
- Advanced Cardiovascular, LLC
- Birmingham VA Health Care System
- University of Alabama at Birmingham
- Grandview Medical Center and Affinity Cardiovascular Specialists, LCC
- Heart Center Research, LLC
- Dignity Health Mercy Gilbert Medical Center
- Mayo Clinic Arizona
- Northeast Arkansas Charitable Foundation, Inc.- NEA Baptist Clinic
- John Muir Health
- University of California San Diego Medical Center
- Long Beach VA Healthcare System
- San Francisco VA Health Care System"
- Lundquist Institute for Biomedical Innovation at Harbor - UCLA Medical Center
- Interventional Cardiology Medical Group
- Christiana Care Health Services, Inc.
- MedStar Washington Hospital Center
- Bay Area Cardiology Associates, P.A.
- Clearwater Cardiovascular Consultants
- University of Florida Health Science Center at Jacksonville
- Baptist Health Research Institute
- Pioneer Clinical Studies (PCS)
- Baptist Hospital
- Ascension Sacred Heart
- Clearwater Cardiovascular Consultants
- Atlanta VA Medical Center
- NorthShore University Healthsystem
- OSF HealthCare Cardiovascular Institute
- Indiana University School of Medicine
- Indiana University Health Ball Memorial Hospital
- Reid Physician Associates
- University of Louisville
- Grace Research, LLC
- Northern Light Eastern Maine Medical Center
- Sinai Hospital Baltimore, LifeBridge Health
- Adventist Healthcare White Oak Medical Center
- University of Michigan (also known as Michigan Medicine and University of Michigan Health Systems)
- MidMichigan Medical Center - Mildland
- Regions Hospital
- Cardiology Associates Research
- University of Missouri Healthcare
- North Kansas City Hospital
- Advanced Heart Care, LLC
- Saint Michael's Medical Center
- St. Joseph's Hospital Cardiology
- VA NY Harbor Healthcare System
- Columbia University Irving Medical Center
- Duke University Medical Center
- Moses H. Cone Memorial Hospital Operation Corporation d/b/a Cone Health
- NC Heart & Vascular Research, LLC
- University Hospitals Cleveland Medical Center
- University of Oklahoma Health Sciences Center
- Wellspan Chambersburg Hospital
- Penn State Health Milton S. Hershey Medical Center
- Penn State Health Medical Group - Berks Cardiology
- Prisma Health - Upstate
- Upstate Cardiology
- Monument Health Clinical Research, Monument Health Rapid City Hospital Inc.
- CHI Institute for Research and Innovation
- Baptist Clinical Research Institute
- Vanderbilt University Medical Center
- Covenant Medical Group d/b/a Parkway Cardiology Associates
- Cardiovascular Research of Knoxville
- Amarillo Heart Clinical Research Institute Inc.
- PharmaTex Research
- The Texas Heart Institute
- Wichita Falls Heart Clinic
- UVA University Hospital
- Inova Heart & Vascular Institute
- Virginia Heart
- Bon Secours St. Mary's Hospital of Richmond, LLC
- Aurora St. Luke's Medical Center
- LKH Universitätsklinikum Graz
- Klinikum Klagenfurt am Woerthersse
- Universitätsklinikum St. Pölten
- Klinik Ottakring
- Karl Landsteiner Institut für Kardiovaskuläre und Intensivmedizinische Forschung
- OLV Aalst
- ZNA Middelheim
- Imelda Hospital
- Hospital Oost-Limburg (ZOL)
- AZ Sint-Lucas
- Jessa Ziekenhuis
- University Hospital Leuven (UZ Leuven)
- AZ Delta Campus Rumbeke
- Mbal Puls
- UMHAT Deva Maria
- MHAT Ivan Skenderov EOOD
- Medical Centre Avitzena
- MHAT Cardiolife OOD
- SHATC Sveti Georgi
- MHAT South-West Hospital, Cardiology Department
- National Heart Hospital
- UMHAT "St. Ekaterina"
- UMHATEM N I Pirogov EAD
- UMHAT St. Anna - Sofia AD
- University of Calgary Foothills Medical Centre
- Royal Alexandra Hospital
- University of Alberta Hospital
- Grey Nuns Community Hospital
- Vancouver General Hospital
- Queen Elizabeth II Health Sciences Centre
- Wiliam Osler Health System
- Cambridge Cardiac Care Center
- York PCI Group, Inc.
- University of Ottawa Heart Institute
- Kawartha Cardiology Clinical Trials
- St. Michael's Hospital
- Clinique de Cardiologie de Lévis
- Montreal Heart Institute
- CHUM - Centre hospitalier de l'Universite de Montreal"
- Hôpital du Sacré-Coeur de Montréal
- CISSSL - Hopital Pierre-Le Gardeur
- Centre Intégré universitaire de santé et de services sociaux de la Mauricie-et-du-Centre-du-Québec
- Hôpital du Sacré-Coeur de Montréal
- Unity Health Toronto - Saint Michaels Site
- University Hospital Brno
- ICRC St. Anne University Hospital
- Regional Hospital Jihlava
- Nemocnice Pardubickeho kraje, a.s. - Pardubicka nemocnice
- Kardiologie Praha s.r.o.
- Institutu Klinicke a Experimentalni Mediciny (IKEM) (Institute for Clinical and Experimental Medicine)
- Univ. Hospital Vinohrady
- Kardiologie Vinohrady s.r.o.
- Všeobecná fakultní nemocnice
- Olomuc Cardiology
- University Hospital Ústí nad Labem
- Regional Hospital Ceské Budejovice
- Aalborg University Hospital Cardiology
- Aarhus University Hospital
- Rigshospitalet
- Esbjerg Hospital
- Goedstrup Region Hospital
- Herning Hospital
- Odense Universitetshospital
- Zealand University Hospital
- Svendborg Hospital
- Viborg Hospital
- The North Estonia Medical Centre
- Heart Clinic, Tartu University Hospital
- Jorvi Hospital, Helsinki University Hospital
- Heart and Lung Center, Helsinki University Hospital
- North Karelian Central Hospital
- StudyCor
- Kokkola Central Hospital
- Kuopio University Hospital
- Oulu University Hospital
- Seinäjoki Central Hospital
- TAYS Tutkimusvastaanotto / TAYS Research Center
- Heart Center, Turku University Hospital
- Hopital Cardiologique CHU Bordeaux
- CH Annecy Genevois
- CHRU Brest - Cavale Blanche
- CHU Caen · Unité Cardiologie et Pathologie Vasculaire
- Hospital Center Departmental Vendée
- CH Chartres
- CHU Timone 2
- Hôpital Arnaud de Villeneuve
- Clinique du Millénaire
- Univ Hosp de Nimes Carémeau
- University Hospitals Pitié Salpêtrière
- Bichat-Claude Bernard Hospital
- Hosp Rangueil - Cardiology A Dept
- CHRU Nancy
- Universitätsklinikum Freiburg; Universitäts-Herzzentrum Freiburg-Bad Krozingen
- Herz- und Diabeteszentrum NRW
- St. Johannes Hospital Dortmund
- Herzzentrum Dresden GmbH; Universitätsklinik an der Technischen Universität Dresden
- Universitätsklinikum Hamburg Eppendorf
- Krankenhaus der Augustinerinnen Köln gGmbH
- Universitätsklinikum Köln
- Herzzentrum Leipzig GmbH
- Gesellschaft für Klinische Forschung mbH Ludwigshafen
- Uniklinikum Magdeburg A. ö. R.
- Universitätsmedizin Mannheim
- München Klinik Neuperlach
- Studienzentrum Innere Med. II Kardiologie, Universitätsklinikum Regensburg
- Kreisklinikum Siegen
- Robert-Bosch Krankenhaus Stuttgart
- Krankenhaus der Barmherzigen Brüder
- Universitätsklinikum Tübingen, Medizinische Klinik Innere Medizin III Kardiologie und Angiologie
- Siteworks GmbH Prüfzentrum Völklingen
- Betegápoló Irgalmasrend Budai Irgalmasrendi Kórház, Kardiológia
- Gottsegen György Országos Kardiovaszkuláris Intézet
- Semmelweis Egyetem Városmajori Szív- és Érgyógyászati Klinika Kardiológia
- Magyar Honvédség Egészségügyi Központ
- Uzsoki Utcai Kórház
- Debreceni Egyetem Klinikai Központ Kardiológiai és Szívsebészeti Klinika
- Szegedi Tudományegyetem ÁOK Szent-Györgyi Albert Klinikai Központ II.sz. Belgyógyászati Klinika és Kardiológiai Központ
- Léda-Platán Magánklinika
- St. James's Hospital
- Soroka University Medical Center
- Hillel Yaffee Medical Center, Cardiology Department
- Rambam Health Care Campus
- Bnai Zion Medical Center, Cardiology
- Edith Wolfson Medical Center
- Shaare Zedek Medical Center, Cardiology Department
- Hadassah Hospital on Mount Scopus
- Meir Medical Center
- Galilee Medical Center
- Rabin Medical Center
- Kaplan Medical Center, Intensive Cardiac Care Unit
- Tel-Aviv Sourasky Medical Center
- Leviev Heart Center, Sheba Medical Center
- Ziv Medical Center
- Shamir Medical Center (Assaf Harofeh)
- San Donato Hospital, U.O.C. Cardiology
- Ospedale Maggiore Bologna - Dept. Cardiology
- AORN Sant'Anna e San Sebastiano
- Azienda Ospedaliero-Universitaria Policlinico ""G. Rodolico - San Marco
- AOU Mater Domini
- University Hospital of Ferrara, Cardiology Unit
- "SOD Cardiologia Interventistica Strutturale, AOU Careggi
- Cardiologia - ASL5 - La Spezia
- A.O.U. Policlinico Gaetano Martino
- University of Naples "Federico II"
- AOU San Luigi Gonzaga Hospital
- Ospedale Policlinico S. Matteo
- Azienda Ospedaliera di Perugia
- Azienda Ospedaliera di Perugia
- Cardiology Department - Santa Chiara Hospital
- Cardiology Department - Santa Chiara Hospital
- Ospedale Ca' Foncello
- Infermi Hospital in Rivoli (Turin)
- Hospital of Lithuanian University of Health Sciences Kauno Klinikos
- Klaipeda Seamen's Hospital
- Republican Panevezys Hospital
- Republican Siauliai Hospital
- Vilnius University Hospital Santaros Klinikos
- Jeroen Bosch Ziekenhuis
- Noordwest Ziekenhuisgroep
- Meander Medisch Centrum
- Onze Lieve Vrouwe Gasthuis, locatie Oost
- Amsterdam UMC
- Gelre Ziekenhuis Apeldoorn
- Deventer Ziekenhuis
- Albert Schweitzer Ziekenhuis
- Gelderse Vallei Ziekenhuis
- Catharina Hospital
- UMC Groningen
- Zuyderland Medical Center
- Vasculair Onderzoek Centrum Hoorn
- Medisch Centrum Leeuwarden
- Radboud UMC
- Canisius-Wilhelmina Ziekenhuis
- Bravis Ziekenhuis
- Ziekenhuis Rivierenland
- Elisabeth-TweeSteden Ziekenhuis
- Diakonessenhuis Utrecht
- Máxima Medisch Centrum
- Viecuri Medisch Centrum
- Akershus University Hospital
- Diakonhjemmet Hospital
- Oslo University Hospital Rikshospitalet
- Oslo University Hospital, Ullevål hospital
- Sykehuset Østfold Kalnes (Trust)
- Vestfold Hospital
- Invasive Cardiology Department, University Teaching Hospital in Białystok
- Górnośląskie Centrum Medyczne w Katowicach, III Oddział Kardiologii
- Szpital Uniwersytecki w Krakowie, Oddział Kliniczny Kardiologii oraz Interwencji Sercowo-Naczyniowych
- Miedziowe Centrum Zdrowia Regionalny, Ośrodek Kardiologiczny, Pracownia Angiografii i Hemodynamiki
- Wielospecjalistyczny Szpital SPZOZ w Nowej Soli
- Wojewódzki Szpital Specjalistyczny w Olsztynie, Oddział Kardiologii
- Szpital Kliniczny im. Heliodora Swiecickiego Uniwersytetu Medycznego im. Karola Marcinkowskiego w Poznaniu
- Oddzial Kardiologii i intensywnej Terapii Kardiologicznej
- Pracownia Kardiologii Inwazyjnej I Katedry i Kliniki Kardiologii Uniwersyteckiego Centrum Klinicznego Warszawskiego Uniwersytetu Medycznego
- Narodowy Instytut Kardiologii
- Uniwersytecki Szpital Kliniczny we Wroclawiu
- SCCS Zabrze I i II Oddział Kardiologii i Angiologii
- Spitalul Judetean de Urgenta ""Dr. Constantin Opris" Baia Mare
- County Clinical Emergency Hospital Brasov
- Carol Davila University of Medicine and Pharmacy - Spitalul Universitar de Urgenta Elias
- Spitalul Clinic de Urgenta Bucuresti
- Niculae Stancioiu"" Heart Institute
- Spital Clinic Judetean de Urgentia Cluj Napoca
- Spitalul Judetean de Urgenta Satu Mare
- Institute of Cardiovascular Diseases Timisoara
- County Clinical Emergency Hospital Tirgu Mures
- Kliničko bolnički centar "Zvezdara"
- University Clinical Center of Serbia (Department for Cardiovascular Disease Cardiology Clinic)
- University Clinical Center of Serbia (Diagnostic and Catheterization Lab)
- University Clinical Center of Serbia (Emergency Cardiology Services)
- University Clinical Center of Serbia
- University Hospital Centre Dr Dragiša Mišovic - Dedinje
- Dedinje Cardiovascular Institute
- Department of Cardiology, Clinical Hospital Center Zemun
- Klinicko bolnicki centar, Bežanijska kosa
- Kliničko Bolnički Centar Bežanijska Kosa
- Klinički centar Kragujevac
- Klinički Centar Niš
- Institute of Cardiovascular Diseases, Vojvodina
- Central Slovak Institute of Cardiovascular Diseases
- Premedix Clinic
- University Hospital Bratislava
- Cardiocentre CINRE
- Východoslovenský ústav srdcových a cievnych chorôb
- University Hospital Martin
- Kardiocentrum Nitra
- Hospital Universitari Germans Trias i Pujol
- Hospital Clinic. Barcelona
- Hospital Universitario Virgen de la Arrixaca
- Hospital Universitari de Bellvitge
- Hospital Universitario de la Princesa
- Hospital Clinico San Carlos
- Hospital Clinico Universitario de Santiago
- Hospital Clinico Valencia
- Hospital Alvaro Cunqueiro, Cardiovascular Unit
- Universitätsspital Basel; Universitäres Herzzentrum
- Inselspital, Universitäatspital Bern, Universitäatklinik für Kardiologie
- Istituto Cardiocentro Ticino
- Kantonsspital St. Gallen
- Royal Papworth Hospital NHS Foundation Trust
- Altnagelvin Area Hospital (WHSCT)
- Freeman Hospital
- North Tyneside General Hospital, Northumbria Healthcare
- Southern Health & Social Care Trust
- Northern General Hospital
- Lister Hospital East and North Hertfordshire NHS Trust
Arms of the Study
Arm 1
Arm 2
Arm Type
Experimental
Placebo Comparator
Arm Label
Selatogrel
Placebo
Arm Description
Study treatment administration may occur at any time between the randomization visit and the final study visit when the participant experiences symptoms suggestive of an acute myocardial infarction. Study treatment administration triggers protocol pre-defined assessments or visits.
Study treatment administration may occur at any time between the randomization visit and the final study visit when the participant experiences symptoms suggestive of an acute myocardial infarction. Study treatment administration triggers protocol pre-defined assessments or visits.
Outcomes
Primary Outcome Measures
Clinical status as assessed by a 6-point ordinal scale
The clinical status will be assessed using a 6-point ordinal scale after any study treatment self-administration. Only the worst clinical outcome will be retained as the primary efficacy outcome. The 6 mutually exclusive outcomes ranked from worst to best are:
Death (all causes), within 7 days after study treatment administration.
Acute myocardial infarction with compromised electro-hemodynamics, within 2 days after study treatment administration.
ST-Elevation Myocardial Infarction (STEMI), within 2 days after study treatment administration.
High-risk Non-ST-Elevation Myocardial Infarction (NSTEMI), within 2 days after study treatment administration.
NSTEMI with peak cardiac troponin greater than 10 times upper limit of normal, within 2 days after study drug administration.
None of the above
Occurrence of Type 3 or 5 treatment-emergent bleeding events according to the Bleeding Academic Research Consortium (BARC) definition
The number of:
Type 3 treatment-emergent bleeding events and
Type 5 treatment-emergent bleeding events
will be assessed according to the Bleeding Academic Research Consortium (BARC) definition (Mehran et al. 2011), within 2 days after study treatment administration.
The Bleeding Academic Research Consortium (BARC) definitions are:
Type 3, bleeding is divided into 3 categories, a through c, and includes clinical, laboratory, and/or imaging evidence of bleeding with specific healthcare provider responses.
Type 5, bleeding is fatal.
Secondary Outcome Measures
Occurrence of death, non-fatal acute myocardial infarction, hospitalization or unplanned emergency department visit for heart failure (Composite endpoint)
Occurrence death, non-fatal acute myocardial infarction, hospitalization or unplanned emergency department visit for heart failure within 30 days after any self-administration.
Full Information
NCT ID
NCT04957719
First Posted
June 28, 2021
Last Updated
September 21, 2023
Sponsor
Idorsia Pharmaceuticals Ltd.
1. Study Identification
Unique Protocol Identification Number
NCT04957719
Brief Title
Selatogrel Outcome Study in Suspected Acute Myocardial Infarction
Acronym
SOS-AMI
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
2. Study Status
Record Verification Date
September 2023
Overall Recruitment Status
Enrolling by invitation
Study Start Date
August 14, 2021 (Actual)
Primary Completion Date
August 2025 (Anticipated)
Study Completion Date
August 2025 (Anticipated)
3. Sponsor/Collaborators
Responsible Party, by Official Title
Sponsor
Name of the Sponsor
Idorsia Pharmaceuticals Ltd.
4. Oversight
Studies a U.S. FDA-regulated Drug Product
Yes
Studies a U.S. FDA-regulated Device Product
Yes
Device Product Not Approved or Cleared by U.S. FDA
Yes
Data Monitoring Committee
Yes
5. Study Description
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.
6. Conditions and Keywords
Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Acute Myocardial Infarction
Keywords
Platelet Aggregation Inhibitors
7. Study Design
Primary Purpose
Treatment
Study Phase
Phase 3
Interventional Study Model
Parallel Assignment
Masking
ParticipantCare ProviderInvestigator
Allocation
Randomized
Enrollment
14000 (Anticipated)
8. Arms, Groups, and Interventions
Arm Title
Selatogrel
Arm Type
Experimental
Arm Description
Study treatment administration may occur at any time between the randomization visit and the final study visit when the participant experiences symptoms suggestive of an acute myocardial infarction. Study treatment administration triggers protocol pre-defined assessments or visits.
Arm Title
Placebo
Arm Type
Placebo Comparator
Arm Description
Study treatment administration may occur at any time between the randomization visit and the final study visit when the participant experiences symptoms suggestive of an acute myocardial infarction. Study treatment administration triggers protocol pre-defined assessments or visits.
Intervention Type
Combination Product
Intervention Name(s)
Selatogrel
Other Intervention Name(s)
ACT-246475
Intervention Description
Selatogrel is a reversible P2Y12 receptor antagonist for subcutaneous administration. Selatogrel will be administered as a liquid formulation in a sealed prefilled syringe in an autoinjector forming an integral ready-to-use, single-dose drug delivery system.
Participants will self-administer 16 mg of selatogrel subcutaneously with the autoinjector upon occurrence of symptoms suggestive of an acute myocardial infarction. Self-administration encompasses the use of the autoinjector by another person (e.g., partner, close relative, friend, caregiver) who may be called for help during the emergency situation of a suspected AMI.
Intervention Type
Combination Product
Intervention Name(s)
Placebo
Intervention Description
Placebo will be administered as a liquid formulation in a sealed prefilled syringe in an autoinjector forming an integral ready-to-use, single-dose drug delivery system.
Participants will self-administer placebo subcutaneously with the autoinjector upon occurrence of symptoms suggestive of an acute myocardial infarction. Self-administration encompasses the use of the autoinjector by another person (e.g., partner, close relative, friend, caregiver) who may be called for help during the emergency situation of a suspected AMI.
Primary Outcome Measure Information:
Title
Clinical status as assessed by a 6-point ordinal scale
Description
The clinical status will be assessed using a 6-point ordinal scale after any study treatment self-administration. Only the worst clinical outcome will be retained as the primary efficacy outcome. The 6 mutually exclusive outcomes ranked from worst to best are:
Death (all causes), within 7 days after study treatment administration.
Acute myocardial infarction with compromised electro-hemodynamics, within 2 days after study treatment administration.
ST-Elevation Myocardial Infarction (STEMI), within 2 days after study treatment administration.
High-risk Non-ST-Elevation Myocardial Infarction (NSTEMI), within 2 days after study treatment administration.
NSTEMI with peak cardiac troponin greater than 10 times upper limit of normal, within 2 days after study drug administration.
None of the above
Time Frame
Total duration: up to 7 days
Title
Occurrence of Type 3 or 5 treatment-emergent bleeding events according to the Bleeding Academic Research Consortium (BARC) definition
Description
The number of:
Type 3 treatment-emergent bleeding events and
Type 5 treatment-emergent bleeding events
will be assessed according to the Bleeding Academic Research Consortium (BARC) definition (Mehran et al. 2011), within 2 days after study treatment administration.
The Bleeding Academic Research Consortium (BARC) definitions are:
Type 3, bleeding is divided into 3 categories, a through c, and includes clinical, laboratory, and/or imaging evidence of bleeding with specific healthcare provider responses.
Type 5, bleeding is fatal.
Time Frame
Total duration: up to 2 days
Secondary Outcome Measure Information:
Title
Occurrence of death, non-fatal acute myocardial infarction, hospitalization or unplanned emergency department visit for heart failure (Composite endpoint)
Description
Occurrence death, non-fatal acute myocardial infarction, hospitalization or unplanned emergency department visit for heart failure within 30 days after any self-administration.
Time Frame
Total duration: up to 30 days
10. Eligibility
Sex
All
Minimum Age & Unit of Time
18 Years
Accepts Healthy Volunteers
No
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 or on the left main artery during a prior cardiac catheterization or cardiac catheterization during the qualifying AMI event and presence of at least 2 of the following risk factors:
Second prior AMI,
Diabetes mellitus defined by ongoing glucose lowering treatment,
Chronic kidney disease with estimated glomerular filtration rate less-than 60 mL/min/1.73 m2,
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.
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Clinical Trials
Organizational Affiliation
Idorsia Pharmaceuticals Ltd.
Official's Role
Study Director
Facility Information:
Facility Name
Advanced Cardiovascular, LLC
City
Alexander City
State/Province
Alabama
ZIP/Postal Code
35010
Country
United States
Facility Name
Birmingham VA Health Care System
City
Birmingham
State/Province
Alabama
ZIP/Postal Code
35233
Country
United States
Facility Name
University of Alabama at Birmingham
City
Birmingham
State/Province
Alabama
ZIP/Postal Code
35233
Country
United States
Facility Name
Grandview Medical Center and Affinity Cardiovascular Specialists, LCC
City
Birmingham
State/Province
Alabama
ZIP/Postal Code
35243
Country
United States
Facility Name
Heart Center Research, LLC
City
Huntsville
State/Province
Alabama
ZIP/Postal Code
35801
Country
United States
Facility Name
Dignity Health Mercy Gilbert Medical Center
City
Gilbert
State/Province
Arizona
ZIP/Postal Code
85297
Country
United States
Facility Name
Mayo Clinic Arizona
City
Phoenix
State/Province
Arizona
ZIP/Postal Code
85054
Country
United States
Facility Name
Northeast Arkansas Charitable Foundation, Inc.- NEA Baptist Clinic
City
Jonesboro
State/Province
Arkansas
ZIP/Postal Code
72405
Country
United States
Facility Name
John Muir Health
City
Concord
State/Province
California
ZIP/Postal Code
94520
Country
United States
Facility Name
University of California San Diego Medical Center
City
La Jolla
State/Province
California
ZIP/Postal Code
92037
Country
United States
Facility Name
Long Beach VA Healthcare System
City
Long Beach
State/Province
California
ZIP/Postal Code
90822
Country
United States
Facility Name
San Francisco VA Health Care System"
City
San Francisco
State/Province
California
ZIP/Postal Code
94121
Country
United States
Facility Name
Lundquist Institute for Biomedical Innovation at Harbor - UCLA Medical Center
City
Torrance
State/Province
California
ZIP/Postal Code
90502
Country
United States
Facility Name
Interventional Cardiology Medical Group
City
West Hills
State/Province
California
ZIP/Postal Code
91307
Country
United States
Facility Name
Christiana Care Health Services, Inc.
City
Newark
State/Province
Delaware
ZIP/Postal Code
19718
Country
United States
Facility Name
MedStar Washington Hospital Center
City
Washington
State/Province
District of Columbia
ZIP/Postal Code
20010
Country
United States
Facility Name
Bay Area Cardiology Associates, P.A.
City
Brandon
State/Province
Florida
ZIP/Postal Code
33511
Country
United States
Facility Name
Clearwater Cardiovascular Consultants
City
Clearwater
State/Province
Florida
ZIP/Postal Code
33756
Country
United States
Facility Name
University of Florida Health Science Center at Jacksonville
City
Jacksonville
State/Province
Florida
ZIP/Postal Code
32209
Country
United States
Facility Name
Baptist Health Research Institute
City
Jacksonville
State/Province
Florida
ZIP/Postal Code
32258
Country
United States
Facility Name
Pioneer Clinical Studies (PCS)
City
Miami
State/Province
Florida
ZIP/Postal Code
33155
Country
United States
Facility Name
Baptist Hospital
City
Pensacola
State/Province
Florida
ZIP/Postal Code
32501
Country
United States
Facility Name
Ascension Sacred Heart
City
Pensacola
State/Province
Florida
ZIP/Postal Code
32504
Country
United States
Facility Name
Clearwater Cardiovascular Consultants
City
Safety Harbor
State/Province
Florida
ZIP/Postal Code
34695
Country
United States
Facility Name
Atlanta VA Medical Center
City
Decatur
State/Province
Georgia
ZIP/Postal Code
30033
Country
United States
Facility Name
NorthShore University Healthsystem
City
Evanston
State/Province
Illinois
ZIP/Postal Code
60201
Country
United States
Facility Name
OSF HealthCare Cardiovascular Institute
City
Peoria
State/Province
Illinois
ZIP/Postal Code
61614
Country
United States
Facility Name
Indiana University School of Medicine
City
Indianapolis
State/Province
Indiana
ZIP/Postal Code
46202
Country
United States
Facility Name
Indiana University Health Ball Memorial Hospital
City
Muncie
State/Province
Indiana
ZIP/Postal Code
47304
Country
United States
Facility Name
Reid Physician Associates
City
Richmond
State/Province
Indiana
ZIP/Postal Code
47374
Country
United States
Facility Name
University of Louisville
City
Louisville
State/Province
Kentucky
ZIP/Postal Code
40202
Country
United States
Facility Name
Grace Research, LLC
City
Bossier City
State/Province
Louisiana
ZIP/Postal Code
71111
Country
United States
Facility Name
Northern Light Eastern Maine Medical Center
City
Bangor
State/Province
Maine
ZIP/Postal Code
04401
Country
United States
Facility Name
Sinai Hospital Baltimore, LifeBridge Health
City
Baltimore
State/Province
Maryland
ZIP/Postal Code
21215
Country
United States
Facility Name
Adventist Healthcare White Oak Medical Center
City
Silver Spring
State/Province
Maryland
ZIP/Postal Code
20904
Country
United States
Facility Name
University of Michigan (also known as Michigan Medicine and University of Michigan Health Systems)
City
Ann Arbor
State/Province
Michigan
ZIP/Postal Code
48109
Country
United States
Facility Name
MidMichigan Medical Center - Mildland
City
Midland
State/Province
Michigan
ZIP/Postal Code
48670
Country
United States
Facility Name
Regions Hospital
City
Saint Paul
State/Province
Minnesota
ZIP/Postal Code
55101
Country
United States
Facility Name
Cardiology Associates Research
City
Tupelo
State/Province
Mississippi
ZIP/Postal Code
38801
Country
United States
Facility Name
University of Missouri Healthcare
City
Columbia
State/Province
Missouri
ZIP/Postal Code
65212
Country
United States
Facility Name
North Kansas City Hospital
City
North Kansas City
State/Province
Missouri
ZIP/Postal Code
64116
Country
United States
Facility Name
Advanced Heart Care, LLC
City
Bridgewater
State/Province
New Jersey
ZIP/Postal Code
08807
Country
United States
Facility Name
Saint Michael's Medical Center
City
Newark
State/Province
New Jersey
ZIP/Postal Code
07102
Country
United States
Facility Name
St. Joseph's Hospital Cardiology
City
Liverpool
State/Province
New York
ZIP/Postal Code
13088
Country
United States
Facility Name
VA NY Harbor Healthcare System
City
New York
State/Province
New York
ZIP/Postal Code
10010
Country
United States
Facility Name
Columbia University Irving Medical Center
City
New York
State/Province
New York
ZIP/Postal Code
10032
Country
United States
Facility Name
Duke University Medical Center
City
Durham
State/Province
North Carolina
ZIP/Postal Code
27710
Country
United States
Facility Name
Moses H. Cone Memorial Hospital Operation Corporation d/b/a Cone Health
City
Greensboro
State/Province
North Carolina
ZIP/Postal Code
27401
Country
United States
Facility Name
NC Heart & Vascular Research, LLC
City
Raleigh
State/Province
North Carolina
ZIP/Postal Code
27607
Country
United States
Facility Name
University Hospitals Cleveland Medical Center
City
Cleveland
State/Province
Ohio
ZIP/Postal Code
44106
Country
United States
Facility Name
University of Oklahoma Health Sciences Center
City
Oklahoma City
State/Province
Oklahoma
ZIP/Postal Code
73104
Country
United States
Facility Name
Wellspan Chambersburg Hospital
City
Chambersburg
State/Province
Pennsylvania
ZIP/Postal Code
17201
Country
United States
Facility Name
Penn State Health Milton S. Hershey Medical Center
City
Hershey
State/Province
Pennsylvania
ZIP/Postal Code
17033
Country
United States
Facility Name
Penn State Health Medical Group - Berks Cardiology
City
Wyomissing
State/Province
Pennsylvania
ZIP/Postal Code
19160
Country
United States
Facility Name
Prisma Health - Upstate
City
Greenville
State/Province
South Carolina
ZIP/Postal Code
29605
Country
United States
Facility Name
Upstate Cardiology
City
Greenville
State/Province
South Carolina
ZIP/Postal Code
29607
Country
United States
Facility Name
Monument Health Clinical Research, Monument Health Rapid City Hospital Inc.
City
Rapid City
State/Province
South Dakota
ZIP/Postal Code
57701
Country
United States
Facility Name
CHI Institute for Research and Innovation
City
Chattanooga
State/Province
Tennessee
ZIP/Postal Code
37404
Country
United States
Facility Name
Baptist Clinical Research Institute
City
Memphis
State/Province
Tennessee
ZIP/Postal Code
38120
Country
United States
Facility Name
Vanderbilt University Medical Center
City
Nashville
State/Province
Tennessee
ZIP/Postal Code
27232
Country
United States
Facility Name
Covenant Medical Group d/b/a Parkway Cardiology Associates
City
Oak Ridge
State/Province
Tennessee
ZIP/Postal Code
37830
Country
United States
Facility Name
Cardiovascular Research of Knoxville
City
Powell
State/Province
Tennessee
ZIP/Postal Code
37849
Country
United States
Facility Name
Amarillo Heart Clinical Research Institute Inc.
City
Amarillo
State/Province
Texas
ZIP/Postal Code
79106
Country
United States
Facility Name
PharmaTex Research
City
Amarillo
State/Province
Texas
ZIP/Postal Code
79109
Country
United States
Facility Name
The Texas Heart Institute
City
Houston
State/Province
Texas
ZIP/Postal Code
77030
Country
United States
Facility Name
Wichita Falls Heart Clinic
City
Wichita Falls
State/Province
Texas
ZIP/Postal Code
76301
Country
United States
Facility Name
UVA University Hospital
City
Charlottesville
State/Province
Virginia
ZIP/Postal Code
22908
Country
United States
Facility Name
Inova Heart & Vascular Institute
City
Falls Church
State/Province
Virginia
ZIP/Postal Code
22042
Country
United States
Facility Name
Virginia Heart
City
Falls Church
State/Province
Virginia
ZIP/Postal Code
22042
Country
United States
Facility Name
Bon Secours St. Mary's Hospital of Richmond, LLC
City
Richmond
State/Province
Virginia
ZIP/Postal Code
23226
Country
United States
Facility Name
Aurora St. Luke's Medical Center
City
Milwaukee
State/Province
Wisconsin
ZIP/Postal Code
53215
Country
United States
Facility Name
LKH Universitätsklinikum Graz
City
Graz
ZIP/Postal Code
8036
Country
Austria
Facility Name
Klinikum Klagenfurt am Woerthersse
City
Klagenfurt
ZIP/Postal Code
9020
Country
Austria
Facility Name
Universitätsklinikum St. Pölten
City
Sankt Pölten
ZIP/Postal Code
3100
Country
Austria
Facility Name
Klinik Ottakring
City
Vienna
ZIP/Postal Code
1160
Country
Austria
Facility Name
Karl Landsteiner Institut für Kardiovaskuläre und Intensivmedizinische Forschung
City
Vienna
ZIP/Postal Code
1210
Country
Austria
Facility Name
OLV Aalst
City
Aalst
ZIP/Postal Code
9300
Country
Belgium
Facility Name
ZNA Middelheim
City
Antwerp
ZIP/Postal Code
2020
Country
Belgium
Facility Name
Imelda Hospital
City
Bonheiden
ZIP/Postal Code
2820
Country
Belgium
Facility Name
Hospital Oost-Limburg (ZOL)
City
Genk
ZIP/Postal Code
3600
Country
Belgium
Facility Name
AZ Sint-Lucas
City
Gent
ZIP/Postal Code
9000
Country
Belgium
Facility Name
Jessa Ziekenhuis
City
Hasselt
ZIP/Postal Code
3500
Country
Belgium
Facility Name
University Hospital Leuven (UZ Leuven)
City
Leuven
ZIP/Postal Code
3000
Country
Belgium
Facility Name
AZ Delta Campus Rumbeke
City
Roeselare
ZIP/Postal Code
8800
Country
Belgium
Facility Name
Mbal Puls
City
Blagoevgrad
ZIP/Postal Code
2700
Country
Bulgaria
Facility Name
UMHAT Deva Maria
City
Burgas
ZIP/Postal Code
8127
Country
Bulgaria
Facility Name
MHAT Ivan Skenderov EOOD
City
Gotse Delchev
ZIP/Postal Code
2900
Country
Bulgaria
Facility Name
Medical Centre Avitzena
City
Kardzhali
ZIP/Postal Code
6600
Country
Bulgaria
Facility Name
MHAT Cardiolife OOD
City
Lovech
ZIP/Postal Code
5500
Country
Bulgaria
Facility Name
SHATC Sveti Georgi
City
Pernik
ZIP/Postal Code
2300
Country
Bulgaria
Facility Name
MHAT South-West Hospital, Cardiology Department
City
Sandanski
ZIP/Postal Code
2802
Country
Bulgaria
Facility Name
National Heart Hospital
City
Sofia
ZIP/Postal Code
1309
Country
Bulgaria
Facility Name
UMHAT "St. Ekaterina"
City
Sofia
ZIP/Postal Code
1431
Country
Bulgaria
Facility Name
UMHATEM N I Pirogov EAD
City
Sofia
ZIP/Postal Code
1606
Country
Bulgaria
Facility Name
UMHAT St. Anna - Sofia AD
City
Sofia
ZIP/Postal Code
1784
Country
Bulgaria
Facility Name
University of Calgary Foothills Medical Centre
City
Calgary
State/Province
Alberta
ZIP/Postal Code
T2N 4Z6
Country
Canada
Facility Name
Royal Alexandra Hospital
City
Edmonton
State/Province
Alberta
ZIP/Postal Code
T5H 3V9
Country
Canada
Facility Name
University of Alberta Hospital
City
Edmonton
State/Province
Alberta
ZIP/Postal Code
T6G 2B7
Country
Canada
Facility Name
Grey Nuns Community Hospital
City
Edmonton
State/Province
Alberta
ZIP/Postal Code
T6L 5X8
Country
Canada
Facility Name
Vancouver General Hospital
City
Vancouver
State/Province
British Columbia
ZIP/Postal Code
V5Z 1M9
Country
Canada
Facility Name
Queen Elizabeth II Health Sciences Centre
City
Halifax
State/Province
Nova Scotia
ZIP/Postal Code
B3H3A7
Country
Canada
Facility Name
Wiliam Osler Health System
City
Brampton
State/Province
Ontario
ZIP/Postal Code
L6R 3J7
Country
Canada
Facility Name
Cambridge Cardiac Care Center
City
Cambridge
State/Province
Ontario
ZIP/Postal Code
N1R 6V6
Country
Canada
Facility Name
York PCI Group, Inc.
City
Newmarket
State/Province
Ontario
ZIP/Postal Code
L3Y 2P7
Country
Canada
Facility Name
University of Ottawa Heart Institute
City
Ottawa
State/Province
Ontario
ZIP/Postal Code
K1Y 4W7
Country
Canada
Facility Name
Kawartha Cardiology Clinical Trials
City
Peterborough
State/Province
Ontario
ZIP/Postal Code
K9J 0B2
Country
Canada
Facility Name
St. Michael's Hospital
City
Toronto
State/Province
Ontario
ZIP/Postal Code
M5B1W8
Country
Canada
Facility Name
Clinique de Cardiologie de Lévis
City
Lévis
State/Province
Quebec
ZIP/Postal Code
G6V 4Z5
Country
Canada
Facility Name
Montreal Heart Institute
City
Montréal
State/Province
Quebec
ZIP/Postal Code
H1T 1C8
Country
Canada
Facility Name
CHUM - Centre hospitalier de l'Universite de Montreal"
City
Montréal
State/Province
Quebec
ZIP/Postal Code
H2X 0A9
Country
Canada
Facility Name
Hôpital du Sacré-Coeur de Montréal
City
Montréal
State/Province
Quebec
ZIP/Postal Code
H4J1C5
Country
Canada
Facility Name
CISSSL - Hopital Pierre-Le Gardeur
City
Terrebonne
State/Province
Quebec
ZIP/Postal Code
J6V 2H2
Country
Canada
Facility Name
Centre Intégré universitaire de santé et de services sociaux de la Mauricie-et-du-Centre-du-Québec
City
Trois-Rivières
State/Province
Quebec
ZIP/Postal Code
G8Z 3R9
Country
Canada
Facility Name
Hôpital du Sacré-Coeur de Montréal
City
Montréal
ZIP/Postal Code
H4J 1C5
Country
Canada
Facility Name
Unity Health Toronto - Saint Michaels Site
City
Toronto
ZIP/Postal Code
M5B 1W8
Country
Canada
Facility Name
University Hospital Brno
City
Brno
ZIP/Postal Code
62500
Country
Czechia
Facility Name
ICRC St. Anne University Hospital
City
Brno
ZIP/Postal Code
65691
Country
Czechia
Facility Name
Regional Hospital Jihlava
City
Jihlava
ZIP/Postal Code
586 33
Country
Czechia
Facility Name
Nemocnice Pardubickeho kraje, a.s. - Pardubicka nemocnice
City
Pardubice
ZIP/Postal Code
53203
Country
Czechia
Facility Name
Kardiologie Praha s.r.o.
City
Prague 10
ZIP/Postal Code
10100
Country
Czechia
Facility Name
Institutu Klinicke a Experimentalni Mediciny (IKEM) (Institute for Clinical and Experimental Medicine)
City
Prague 4
ZIP/Postal Code
140 21
Country
Czechia
Facility Name
Univ. Hospital Vinohrady
City
Prague
ZIP/Postal Code
10034
Country
Czechia
Facility Name
Kardiologie Vinohrady s.r.o.
City
Praha 1 - Nové Mesto
ZIP/Postal Code
11000
Country
Czechia
Facility Name
Všeobecná fakultní nemocnice
City
Praha
ZIP/Postal Code
12808
Country
Czechia
Facility Name
Olomuc Cardiology
City
Prostějov
ZIP/Postal Code
79601
Country
Czechia
Facility Name
University Hospital Ústí nad Labem
City
Ústí Nad Labem
ZIP/Postal Code
40013
Country
Czechia
Facility Name
Regional Hospital Ceské Budejovice
City
České Budějovice
ZIP/Postal Code
37001
Country
Czechia
Facility Name
Aalborg University Hospital Cardiology
City
Aalborg
ZIP/Postal Code
9000
Country
Denmark
Facility Name
Aarhus University Hospital
City
Aarhus
ZIP/Postal Code
8200
Country
Denmark
Facility Name
Rigshospitalet
City
Copenhagen
ZIP/Postal Code
2100
Country
Denmark
Facility Name
Esbjerg Hospital
City
Esbjerg
ZIP/Postal Code
6700
Country
Denmark
Facility Name
Goedstrup Region Hospital
City
Herning
ZIP/Postal Code
7400
Country
Denmark
Facility Name
Herning Hospital
City
Herning
ZIP/Postal Code
7400
Country
Denmark
Facility Name
Odense Universitetshospital
City
Odense
ZIP/Postal Code
5000
Country
Denmark
Facility Name
Zealand University Hospital
City
Roskilde
ZIP/Postal Code
4000
Country
Denmark
Facility Name
Svendborg Hospital
City
Svendborg
ZIP/Postal Code
5700
Country
Denmark
Facility Name
Viborg Hospital
City
Viborg
ZIP/Postal Code
8800
Country
Denmark
Facility Name
The North Estonia Medical Centre
City
Tallinn
ZIP/Postal Code
13419
Country
Estonia
Facility Name
Heart Clinic, Tartu University Hospital
City
Tartu
ZIP/Postal Code
50406
Country
Estonia
Facility Name
Jorvi Hospital, Helsinki University Hospital
City
Espoo
ZIP/Postal Code
02740
Country
Finland
Facility Name
Heart and Lung Center, Helsinki University Hospital
City
Helsinki
ZIP/Postal Code
00290
Country
Finland
Facility Name
North Karelian Central Hospital
City
Joensuu
ZIP/Postal Code
80210
Country
Finland
Facility Name
StudyCor
City
Jyväskylä
ZIP/Postal Code
40620
Country
Finland
Facility Name
Kokkola Central Hospital
City
Kokkola
ZIP/Postal Code
67200
Country
Finland
Facility Name
Kuopio University Hospital
City
Kuopio
ZIP/Postal Code
70210
Country
Finland
Facility Name
Oulu University Hospital
City
Oulu
ZIP/Postal Code
90220
Country
Finland
Facility Name
Seinäjoki Central Hospital
City
Seinäjoki
ZIP/Postal Code
60220
Country
Finland
Facility Name
TAYS Tutkimusvastaanotto / TAYS Research Center
City
Tampere
ZIP/Postal Code
335200
Country
Finland
Facility Name
Heart Center, Turku University Hospital
City
Turku
ZIP/Postal Code
20520
Country
Finland
Facility Name
Hopital Cardiologique CHU Bordeaux
City
Pessac
State/Province
Gironde
ZIP/Postal Code
33604
Country
France
Facility Name
CH Annecy Genevois
City
Annecy
ZIP/Postal Code
74370
Country
France
Facility Name
CHRU Brest - Cavale Blanche
City
Brest
ZIP/Postal Code
29200
Country
France
Facility Name
CHU Caen · Unité Cardiologie et Pathologie Vasculaire
City
Caen
ZIP/Postal Code
14033
Country
France
Facility Name
Hospital Center Departmental Vendée
City
La Roche-sur-Yon
ZIP/Postal Code
85925
Country
France
Facility Name
CH Chartres
City
Le Coudray
ZIP/Postal Code
28630
Country
France
Facility Name
CHU Timone 2
City
Marseille
ZIP/Postal Code
13385
Country
France
Facility Name
Hôpital Arnaud de Villeneuve
City
Montpellier
ZIP/Postal Code
34295
Country
France
Facility Name
Clinique du Millénaire
City
Montpellier
ZIP/Postal Code
34680
Country
France
Facility Name
Univ Hosp de Nimes Carémeau
City
Nîmes
ZIP/Postal Code
30000
Country
France
Facility Name
University Hospitals Pitié Salpêtrière
City
Paris
ZIP/Postal Code
75013
Country
France
Facility Name
Bichat-Claude Bernard Hospital
City
Paris
ZIP/Postal Code
75018
Country
France
Facility Name
Hosp Rangueil - Cardiology A Dept
City
Toulouse
ZIP/Postal Code
31059
Country
France
Facility Name
CHRU Nancy
City
Vandœuvre-lès-Nancy
ZIP/Postal Code
54500
Country
France
Facility Name
Universitätsklinikum Freiburg; Universitäts-Herzzentrum Freiburg-Bad Krozingen
City
Bad Krozingen
ZIP/Postal Code
79189
Country
Germany
Facility Name
Herz- und Diabeteszentrum NRW
City
Bad Oeynhausen
ZIP/Postal Code
32545
Country
Germany
Facility Name
St. Johannes Hospital Dortmund
City
Dortmund
ZIP/Postal Code
44137
Country
Germany
Facility Name
Herzzentrum Dresden GmbH; Universitätsklinik an der Technischen Universität Dresden
City
Dresden
ZIP/Postal Code
01307
Country
Germany
Facility Name
Universitätsklinikum Hamburg Eppendorf
City
Hamburg
ZIP/Postal Code
20246
Country
Germany
Facility Name
Krankenhaus der Augustinerinnen Köln gGmbH
City
Köln
ZIP/Postal Code
50678
Country
Germany
Facility Name
Universitätsklinikum Köln
City
Köln
ZIP/Postal Code
50937
Country
Germany
Facility Name
Herzzentrum Leipzig GmbH
City
Leipzig
ZIP/Postal Code
04289
Country
Germany
Facility Name
Gesellschaft für Klinische Forschung mbH Ludwigshafen
City
Ludwigshafen
ZIP/Postal Code
67063
Country
Germany
Facility Name
Uniklinikum Magdeburg A. ö. R.
City
Magdeburg
ZIP/Postal Code
39120
Country
Germany
Facility Name
Universitätsmedizin Mannheim
City
Mannheim
ZIP/Postal Code
68167
Country
Germany
Facility Name
München Klinik Neuperlach
City
München
ZIP/Postal Code
81737
Country
Germany
Facility Name
Studienzentrum Innere Med. II Kardiologie, Universitätsklinikum Regensburg
City
Regensburg
ZIP/Postal Code
93053
Country
Germany
Facility Name
Kreisklinikum Siegen
City
Siegen
ZIP/Postal Code
57076
Country
Germany
Facility Name
Robert-Bosch Krankenhaus Stuttgart
City
Stuttgart
ZIP/Postal Code
70376
Country
Germany
Facility Name
Krankenhaus der Barmherzigen Brüder
City
Trier
ZIP/Postal Code
54292
Country
Germany
Facility Name
Universitätsklinikum Tübingen, Medizinische Klinik Innere Medizin III Kardiologie und Angiologie
City
Tübingen
ZIP/Postal Code
72076
Country
Germany
Facility Name
Siteworks GmbH Prüfzentrum Völklingen
City
Völklingen
ZIP/Postal Code
66333
Country
Germany
Facility Name
Betegápoló Irgalmasrend Budai Irgalmasrendi Kórház, Kardiológia
City
Budapest
ZIP/Postal Code
1023
Country
Hungary
Facility Name
Gottsegen György Országos Kardiovaszkuláris Intézet
City
Budapest
ZIP/Postal Code
1096
Country
Hungary
Facility Name
Semmelweis Egyetem Városmajori Szív- és Érgyógyászati Klinika Kardiológia
City
Budapest
ZIP/Postal Code
1122
Country
Hungary
Facility Name
Magyar Honvédség Egészségügyi Központ
City
Budapest
ZIP/Postal Code
1134
Country
Hungary
Facility Name
Uzsoki Utcai Kórház
City
Budapest
ZIP/Postal Code
1145
Country
Hungary
Facility Name
Debreceni Egyetem Klinikai Központ Kardiológiai és Szívsebészeti Klinika
City
Debrecen
ZIP/Postal Code
4032
Country
Hungary
Facility Name
Szegedi Tudományegyetem ÁOK Szent-Györgyi Albert Klinikai Központ II.sz. Belgyógyászati Klinika és Kardiológiai Központ
City
Szeged
ZIP/Postal Code
6725
Country
Hungary
Facility Name
Léda-Platán Magánklinika
City
Zalaegerszeg
ZIP/Postal Code
8900
Country
Hungary
Facility Name
St. James's Hospital
City
Dublin
ZIP/Postal Code
D08 A978
Country
Ireland
Facility Name
Soroka University Medical Center
City
Beer-Sheva
ZIP/Postal Code
84100
Country
Israel
Facility Name
Hillel Yaffee Medical Center, Cardiology Department
City
Hadera
ZIP/Postal Code
3810101
Country
Israel
Facility Name
Rambam Health Care Campus
City
Haifa
ZIP/Postal Code
3109601
Country
Israel
Facility Name
Bnai Zion Medical Center, Cardiology
City
Haifa
ZIP/Postal Code
3339419
Country
Israel
Facility Name
Edith Wolfson Medical Center
City
H̱olon
ZIP/Postal Code
5822012
Country
Israel
Facility Name
Shaare Zedek Medical Center, Cardiology Department
City
Jerusalem
ZIP/Postal Code
9103102
Country
Israel
Facility Name
Hadassah Hospital on Mount Scopus
City
Jerusalem
ZIP/Postal Code
9765422
Country
Israel
Facility Name
Meir Medical Center
City
Kfar Sava
ZIP/Postal Code
4428164
Country
Israel
Facility Name
Galilee Medical Center
City
Nahariya
ZIP/Postal Code
2210001
Country
Israel
Facility Name
Rabin Medical Center
City
Petah tikva
ZIP/Postal Code
49100
Country
Israel
Facility Name
Kaplan Medical Center, Intensive Cardiac Care Unit
City
Rehovot
ZIP/Postal Code
76100
Country
Israel
Facility Name
Tel-Aviv Sourasky Medical Center
City
Tel Aviv
ZIP/Postal Code
6423906
Country
Israel
Facility Name
Leviev Heart Center, Sheba Medical Center
City
Tel Hashomer
ZIP/Postal Code
5265601
Country
Israel
Facility Name
Ziv Medical Center
City
Zefat
ZIP/Postal Code
13100
Country
Israel
Facility Name
Shamir Medical Center (Assaf Harofeh)
City
Zerifin
ZIP/Postal Code
6093000
Country
Israel
Facility Name
San Donato Hospital, U.O.C. Cardiology
City
Arezzo
ZIP/Postal Code
52100
Country
Italy
Facility Name
Ospedale Maggiore Bologna - Dept. Cardiology
City
Bologna
ZIP/Postal Code
40133
Country
Italy
Facility Name
AORN Sant'Anna e San Sebastiano
City
Caserta
ZIP/Postal Code
81100
Country
Italy
Facility Name
Azienda Ospedaliero-Universitaria Policlinico ""G. Rodolico - San Marco
City
Catania
ZIP/Postal Code
95100
Country
Italy
Facility Name
AOU Mater Domini
City
Catanzaro
ZIP/Postal Code
88100
Country
Italy
Facility Name
University Hospital of Ferrara, Cardiology Unit
City
Cona
ZIP/Postal Code
44124
Country
Italy
Facility Name
"SOD Cardiologia Interventistica Strutturale, AOU Careggi
City
Firenze
ZIP/Postal Code
50134
Country
Italy
Facility Name
Cardiologia - ASL5 - La Spezia
City
La Spezia
ZIP/Postal Code
19121
Country
Italy
Facility Name
A.O.U. Policlinico Gaetano Martino
City
Messina
ZIP/Postal Code
98124
Country
Italy
Facility Name
University of Naples "Federico II"
City
Napoli
ZIP/Postal Code
80131
Country
Italy
Facility Name
AOU San Luigi Gonzaga Hospital
City
Orbassano
ZIP/Postal Code
10043
Country
Italy
Facility Name
Ospedale Policlinico S. Matteo
City
Pavia
ZIP/Postal Code
27100
Country
Italy
Facility Name
Azienda Ospedaliera di Perugia
City
Perugia
ZIP/Postal Code
06129
Country
Italy
Facility Name
Azienda Ospedaliera di Perugia
City
Perugia
ZIP/Postal Code
6129
Country
Italy
Facility Name
Cardiology Department - Santa Chiara Hospital
City
Trento
ZIP/Postal Code
338122
Country
Italy
Facility Name
Cardiology Department - Santa Chiara Hospital
City
Trento
ZIP/Postal Code
38122
Country
Italy
Facility Name
Ospedale Ca' Foncello
City
Treviso
ZIP/Postal Code
31100
Country
Italy
Facility Name
Infermi Hospital in Rivoli (Turin)
City
Turin
ZIP/Postal Code
10098
Country
Italy
Facility Name
Hospital of Lithuanian University of Health Sciences Kauno Klinikos
City
Kaunas
ZIP/Postal Code
50161
Country
Lithuania
Facility Name
Klaipeda Seamen's Hospital
City
Klaipeda
ZIP/Postal Code
92288
Country
Lithuania
Facility Name
Republican Panevezys Hospital
City
Panevezys
ZIP/Postal Code
35144
Country
Lithuania
Facility Name
Republican Siauliai Hospital
City
Siauliai
ZIP/Postal Code
76231
Country
Lithuania
Facility Name
Vilnius University Hospital Santaros Klinikos
City
Vilnius
ZIP/Postal Code
08661
Country
Lithuania
Facility Name
Jeroen Bosch Ziekenhuis
City
's-Hertogenbosch
ZIP/Postal Code
5223 GZ
Country
Netherlands
Facility Name
Noordwest Ziekenhuisgroep
City
Alkmaar
ZIP/Postal Code
1815 JD
Country
Netherlands
Facility Name
Meander Medisch Centrum
City
Amersfoort
ZIP/Postal Code
3813TZ
Country
Netherlands
Facility Name
Onze Lieve Vrouwe Gasthuis, locatie Oost
City
Amsterdam
ZIP/Postal Code
1091 AC
Country
Netherlands
Facility Name
Amsterdam UMC
City
Amsterdam
ZIP/Postal Code
1105 AZ
Country
Netherlands
Facility Name
Gelre Ziekenhuis Apeldoorn
City
Apeldoorn
ZIP/Postal Code
7334 DZ
Country
Netherlands
Facility Name
Deventer Ziekenhuis
City
Deventer
ZIP/Postal Code
7416SE
Country
Netherlands
Facility Name
Albert Schweitzer Ziekenhuis
City
Dordrecht
ZIP/Postal Code
3318AT
Country
Netherlands
Facility Name
Gelderse Vallei Ziekenhuis
City
Ede
ZIP/Postal Code
6716 RP
Country
Netherlands
Facility Name
Catharina Hospital
City
Eindhoven
ZIP/Postal Code
5623 EJ
Country
Netherlands
Facility Name
UMC Groningen
City
Groningen
ZIP/Postal Code
9700 RB
Country
Netherlands
Facility Name
Zuyderland Medical Center
City
Heerlen
ZIP/Postal Code
6419 PC
Country
Netherlands
Facility Name
Vasculair Onderzoek Centrum Hoorn
City
Hoorn
ZIP/Postal Code
1624 NP
Country
Netherlands
Facility Name
Medisch Centrum Leeuwarden
City
Leeuwarden
ZIP/Postal Code
8934 AD
Country
Netherlands
Facility Name
Radboud UMC
City
Nijmegen
ZIP/Postal Code
6525GA
Country
Netherlands
Facility Name
Canisius-Wilhelmina Ziekenhuis
City
Nijmegen
ZIP/Postal Code
6532SZ
Country
Netherlands
Facility Name
Bravis Ziekenhuis
City
Roosendaal
ZIP/Postal Code
4708AE
Country
Netherlands
Facility Name
Ziekenhuis Rivierenland
City
Tiel
ZIP/Postal Code
4002WP
Country
Netherlands
Facility Name
Elisabeth-TweeSteden Ziekenhuis
City
Tilburg
ZIP/Postal Code
5042AD
Country
Netherlands
Facility Name
Diakonessenhuis Utrecht
City
Utrecht
ZIP/Postal Code
3582KE
Country
Netherlands
Facility Name
Máxima Medisch Centrum
City
Veldhoven
ZIP/Postal Code
5504DB
Country
Netherlands
Facility Name
Viecuri Medisch Centrum
City
Venlo
ZIP/Postal Code
5912BL
Country
Netherlands
Facility Name
Akershus University Hospital
City
Lørenskog
ZIP/Postal Code
1478
Country
Norway
Facility Name
Diakonhjemmet Hospital
City
Oslo
ZIP/Postal Code
0370
Country
Norway
Facility Name
Oslo University Hospital Rikshospitalet
City
Oslo
ZIP/Postal Code
0372
Country
Norway
Facility Name
Oslo University Hospital, Ullevål hospital
City
Oslo
ZIP/Postal Code
0450
Country
Norway
Facility Name
Sykehuset Østfold Kalnes (Trust)
City
Sarpsborg
ZIP/Postal Code
1714
Country
Norway
Facility Name
Vestfold Hospital
City
Tønsberg
ZIP/Postal Code
3103
Country
Norway
Facility Name
Invasive Cardiology Department, University Teaching Hospital in Białystok
City
Białystok
ZIP/Postal Code
15-276
Country
Poland
Facility Name
Górnośląskie Centrum Medyczne w Katowicach, III Oddział Kardiologii
City
Katowice
ZIP/Postal Code
40-635
Country
Poland
Facility Name
Szpital Uniwersytecki w Krakowie, Oddział Kliniczny Kardiologii oraz Interwencji Sercowo-Naczyniowych
City
Kraków
ZIP/Postal Code
30-688
Country
Poland
Facility Name
Miedziowe Centrum Zdrowia Regionalny, Ośrodek Kardiologiczny, Pracownia Angiografii i Hemodynamiki
City
Lublin
ZIP/Postal Code
59-301
Country
Poland
Facility Name
Wielospecjalistyczny Szpital SPZOZ w Nowej Soli
City
Nowa Sól
ZIP/Postal Code
67-100
Country
Poland
Facility Name
Wojewódzki Szpital Specjalistyczny w Olsztynie, Oddział Kardiologii
City
Olsztyn
ZIP/Postal Code
10-561
Country
Poland
Facility Name
Szpital Kliniczny im. Heliodora Swiecickiego Uniwersytetu Medycznego im. Karola Marcinkowskiego w Poznaniu
City
Poznań
ZIP/Postal Code
61-848
Country
Poland
Facility Name
Oddzial Kardiologii i intensywnej Terapii Kardiologicznej
City
Toruń
ZIP/Postal Code
87-100
Country
Poland
Facility Name
Pracownia Kardiologii Inwazyjnej I Katedry i Kliniki Kardiologii Uniwersyteckiego Centrum Klinicznego Warszawskiego Uniwersytetu Medycznego
City
Warsaw
ZIP/Postal Code
02-097
Country
Poland
Facility Name
Narodowy Instytut Kardiologii
City
Warsaw
ZIP/Postal Code
04-628
Country
Poland
Facility Name
Uniwersytecki Szpital Kliniczny we Wroclawiu
City
Wrocław
ZIP/Postal Code
50-556
Country
Poland
Facility Name
SCCS Zabrze I i II Oddział Kardiologii i Angiologii
City
Zabrze
ZIP/Postal Code
41-800
Country
Poland
Facility Name
Spitalul Judetean de Urgenta ""Dr. Constantin Opris" Baia Mare
City
Baia Mare
ZIP/Postal Code
430110
Country
Romania
Facility Name
County Clinical Emergency Hospital Brasov
City
Braşov
ZIP/Postal Code
500236
Country
Romania
Facility Name
Carol Davila University of Medicine and Pharmacy - Spitalul Universitar de Urgenta Elias
City
Bucharest
ZIP/Postal Code
011461
Country
Romania
Facility Name
Spitalul Clinic de Urgenta Bucuresti
City
Bucharest
ZIP/Postal Code
014461
Country
Romania
Facility Name
Niculae Stancioiu"" Heart Institute
City
Cluj-Napoca
ZIP/Postal Code
400001
Country
Romania
Facility Name
Spital Clinic Judetean de Urgentia Cluj Napoca
City
Cluj-Napoca
ZIP/Postal Code
400659
Country
Romania
Facility Name
Spitalul Judetean de Urgenta Satu Mare
City
Satu Mare
ZIP/Postal Code
440192
Country
Romania
Facility Name
Institute of Cardiovascular Diseases Timisoara
City
Timişoara
ZIP/Postal Code
300310
Country
Romania
Facility Name
County Clinical Emergency Hospital Tirgu Mures
City
Târgu-Mureş
ZIP/Postal Code
540136
Country
Romania
Facility Name
Kliničko bolnički centar "Zvezdara"
City
Belgrade
ZIP/Postal Code
11000
Country
Serbia
Facility Name
University Clinical Center of Serbia (Department for Cardiovascular Disease Cardiology Clinic)
City
Belgrade
ZIP/Postal Code
11000
Country
Serbia
Facility Name
University Clinical Center of Serbia (Diagnostic and Catheterization Lab)
City
Belgrade
ZIP/Postal Code
11000
Country
Serbia
Facility Name
University Clinical Center of Serbia (Emergency Cardiology Services)
City
Belgrade
ZIP/Postal Code
11000
Country
Serbia
Facility Name
University Clinical Center of Serbia
City
Belgrade
ZIP/Postal Code
11000
Country
Serbia
Facility Name
University Hospital Centre Dr Dragiša Mišovic - Dedinje
City
Belgrade
ZIP/Postal Code
11000
Country
Serbia
Facility Name
Dedinje Cardiovascular Institute
City
Belgrade
ZIP/Postal Code
11040
Country
Serbia
Facility Name
Department of Cardiology, Clinical Hospital Center Zemun
City
Belgrade
ZIP/Postal Code
11080
Country
Serbia
Facility Name
Klinicko bolnicki centar, Bežanijska kosa
City
Belgrade
ZIP/Postal Code
11080
Country
Serbia
Facility Name
Kliničko Bolnički Centar Bežanijska Kosa
City
Belgrade
ZIP/Postal Code
11080
Country
Serbia
Facility Name
Klinički centar Kragujevac
City
Kragujevac
ZIP/Postal Code
34000
Country
Serbia
Facility Name
Klinički Centar Niš
City
Niš
ZIP/Postal Code
18000
Country
Serbia
Facility Name
Institute of Cardiovascular Diseases, Vojvodina
City
Sremska Kamenica
ZIP/Postal Code
21204
Country
Serbia
Facility Name
Central Slovak Institute of Cardiovascular Diseases
City
Banska Bystrica
ZIP/Postal Code
97401
Country
Slovakia
Facility Name
Premedix Clinic
City
Bratislava
ZIP/Postal Code
811 02
Country
Slovakia
Facility Name
University Hospital Bratislava
City
Bratislava
ZIP/Postal Code
813 69
Country
Slovakia
Facility Name
Cardiocentre CINRE
City
Bratislava
ZIP/Postal Code
851 05
Country
Slovakia
Facility Name
Východoslovenský ústav srdcových a cievnych chorôb
City
Košice
ZIP/Postal Code
04011
Country
Slovakia
Facility Name
University Hospital Martin
City
Martin
ZIP/Postal Code
03659
Country
Slovakia
Facility Name
Kardiocentrum Nitra
City
Nitra
ZIP/Postal Code
94901
Country
Slovakia
Facility Name
Hospital Universitari Germans Trias i Pujol
City
Badalona
ZIP/Postal Code
08916
Country
Spain
Facility Name
Hospital Clinic. Barcelona
City
Barcelona
ZIP/Postal Code
08036
Country
Spain
Facility Name
Hospital Universitario Virgen de la Arrixaca
City
El Palmar
ZIP/Postal Code
30120
Country
Spain
Facility Name
Hospital Universitari de Bellvitge
City
L'Hospitalet De Llobregat
ZIP/Postal Code
08907
Country
Spain
Facility Name
Hospital Universitario de la Princesa
City
Madrid
ZIP/Postal Code
28006
Country
Spain
Facility Name
Hospital Clinico San Carlos
City
Madrid
ZIP/Postal Code
28040
Country
Spain
Facility Name
Hospital Clinico Universitario de Santiago
City
Santiago De Compostela
ZIP/Postal Code
15706
Country
Spain
Facility Name
Hospital Clinico Valencia
City
Valencia
ZIP/Postal Code
46010
Country
Spain
Facility Name
Hospital Alvaro Cunqueiro, Cardiovascular Unit
City
Vigo
ZIP/Postal Code
36213
Country
Spain
Facility Name
Universitätsspital Basel; Universitäres Herzzentrum
City
Basel
ZIP/Postal Code
4031
Country
Switzerland
Facility Name
Inselspital, Universitäatspital Bern, Universitäatklinik für Kardiologie
City
Bern
ZIP/Postal Code
3010
Country
Switzerland
Facility Name
Istituto Cardiocentro Ticino
City
Lugano
ZIP/Postal Code
6900
Country
Switzerland
Facility Name
Kantonsspital St. Gallen
City
Saint Gallen
ZIP/Postal Code
9007
Country
Switzerland
Facility Name
Royal Papworth Hospital NHS Foundation Trust
City
Cambridge
ZIP/Postal Code
CB2 0AY
Country
United Kingdom
Facility Name
Altnagelvin Area Hospital (WHSCT)
City
Londonderry
ZIP/Postal Code
BT47 65B
Country
United Kingdom
Facility Name
Freeman Hospital
City
Newcastle
ZIP/Postal Code
NE77DN
Country
United Kingdom
Facility Name
North Tyneside General Hospital, Northumbria Healthcare
City
North Shields
ZIP/Postal Code
NE29 8NH
Country
United Kingdom
Facility Name
Southern Health & Social Care Trust
City
Portadown
ZIP/Postal Code
BT63 5QQ
Country
United Kingdom
Facility Name
Northern General Hospital
City
Sheffield
ZIP/Postal Code
S5 7AU
Country
United Kingdom
Facility Name
Lister Hospital East and North Hertfordshire NHS Trust
City
Stevenage
ZIP/Postal Code
SG1 4AB
Country
United Kingdom
12. IPD Sharing Statement
Plan to Share IPD
No
Citations:
PubMed Identifier
30153967
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.
Results Reference
background
PubMed Identifier
21670242
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.
Results Reference
background
Learn more about this trial
Selatogrel Outcome Study in Suspected Acute Myocardial Infarction
We'll reach out to this number within 24 hrs