Selatogrel Outcome Study in Suspected Acute Myocardial Infarction

Acute Myocardial Infarction Clinical Trial

— 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

Clinical Trial Details — Status: Enrolling by invitation

Administrative data

• NCT number: NCT04957719
• Other study ID #: ID-076A301
• Secondary ID: 2020-000983-41
• Status: Enrolling by invitation
• Phase: Phase 3
• Start date: August 14, 2021
• Est. completion date: August 13, 2025

Study information

• Verified date: June 2024
• Source: Idorsia Pharmaceuticals Ltd.
• Contact: n/a
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial 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.

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.

Recruitment information / eligibility

• Status: Enrolling by invitation
• Enrollment: 14000
• Est. completion date: August 13, 2025
• Est. primary completion date: August 13, 2025
• Accepts healthy volunteers: No
• Gender: All
• Age group: 18 Years and older

Eligibility

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.

Related Conditions & MeSH terms

• Acute Myocardial Infarction
• Infarction
• Myocardial Infarction

Intervention

Combination Product:
• Selatogrel
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.
• Placebo
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.

Locations

Country	Name	City	State
Austria	LKH Universitätsklinikum Graz	Graz
Austria	Klinikum Klagenfurt am Woerthersse	Klagenfurt
Austria	Universitätsklinikum St. Pölten	Sankt Pölten
Austria	Karl Landsteiner Institut für Kardiovaskuläre und Intensivmedizinische Forschung	Vienna
Austria	Klinik Ottakring	Vienna
Belgium	OLV Aalst	Aalst
Belgium	Hospital Oost-Limburg (ZOL)	Genk
Belgium	AZ Sint-Lucas	Gent
Belgium	University Hospital Leuven (UZ Leuven)	Leuven
Belgium	AZ Delta Campus Rumbeke	Roeselare
Bulgaria	Mbal Puls	Blagoevgrad
Bulgaria	UMHAT Deva Maria	Burgas
Bulgaria	MHAT Ivan Skenderov EOOD	Gotse Delchev
Bulgaria	Medical Centre Avitzena	Kardzhali
Bulgaria	MHAT Cardiolife OOD	Lovech
Bulgaria	SHATC Sveti Georgi	Pernik
Bulgaria	MHAT South-West Hospital, Cardiology Department	Sandanski
Bulgaria	UMHAT St. Anna - Sofia AD	Sofia
Bulgaria	UMHATEM N I Pirogov EAD	Sofia
Canada	Wiliam Osler Health System	Brampton	Ontario
Canada	University of Calgary Foothills Medical Centre	Calgary	Alberta
Canada	Cambridge Cardiac Care Center	Cambridge	Ontario
Canada	Grey Nuns Community Hospital	Edmonton	Alberta
Canada	Royal Alexandra Hospital	Edmonton	Alberta
Canada	University of Alberta Hospital	Edmonton	Alberta
Canada	Queen Elizabeth II Health Sciences Centre	Halifax	Nova Scotia
Canada	Clinique de Cardiologie de Lévis	Lévis	Quebec
Canada	CHUM - Centre hospitalier de l'Universite de Montreal"	Montréal	Quebec
Canada	Hôpital du Sacré-Coeur de Montréal	Montréal	Quebec
Canada	Hôpital du Sacré-Coeur de Montréal	Montréal
Canada	Montreal Heart Institute	Montréal	Quebec
Canada	York PCI Group, Inc.	Newmarket	Ontario
Canada	University of Ottawa Heart Institute	Ottawa	Ontario
Canada	Kawartha Cardiology Clinical Trials	Peterborough	Ontario
Canada	CISSSL - Hopital Pierre-Le Gardeur	Terrebonne	Quebec
Canada	St. Michael's Hospital	Toronto	Ontario
Canada	Unity Health Toronto - Saint Michaels Site	Toronto
Canada	Centre Intégré universitaire de santé et de services sociaux de la Mauricie-et-du-Centre-du-Québec	Trois-Rivières	Quebec
Canada	Vancouver General Hospital	Vancouver	British Columbia
China	Beijing Anzhen Hospital, Capital Medical University	Beijing
China	Beijing Luhe Hospital, Capital Medical University	Beijing
China	The First Bethune Hospital of Jilin University	Changchun
China	The Second Hospital of Jilin University	Changchun
China	The Second Xiangya Hospital of Central South University	Changsha
China	The Third Xiangya Hospital of Central South University	Changsha
China	Xiangya Hospital Central South University	Changsha
China	West China Hospital of Sichuan University	Chengdu
China	Daqing Oilfield General hospital	Daqing
China	Beijing Hospital	Dongcheng
China	Fujian Provincial Hospital	Fuzhou
China	Guangdong Provincial People's Hospital	Guangzhou
China	Sir Run Run Shaw Hospital (SRRSH), affiliated with the Zhejiang University School of Medicine	Hangzhou
China	The First Affiliated Hospital, Zhejiang University School of Medicine	Hangzhou
China	The First Affiliated Hospital of USTC(Anhui Provincial Hospital)	Hefei
China	The Second Hospital of Shandong University	Jinan
China	Nanjing Drum Tower Hospital	Nanjing
China	Zhongda Hospital Southeast University	Nanjing
China	Renji Hospital, Shanghai Jiaotong University School of Medicine	Shanghai
China	Shanghai Chest Hospital ,Shanghai Jiao Tong University School of Medicine	Shanghai
China	Shanghai General Hospital	Shanghai
China	Shanghai Ninth People's hospital, Shanghai Jiaotong University School of Medicine	Shanghai
China	Shanghai Sixth People's hospital, Shanghai Jiaotong University School of Medicine	Shanghai
China	The People's Hospital of Liaoning Province	Shenyang
China	Tianjin Medical University General Hospital	Tianjin
China	Renmin Hospital of Wuhan University	Wuhan
China	The Central Hospital of Wuhan	Wuhan
China	The First Affiliated Hospital of Xi'an Jiaotong University	Xi'an
China	The First Affiliated Hospital of Zhengzhou University	Zhengzhou
Czechia	ICRC St. Anne University Hospital	Brno
Czechia	University Hospital Brno	Brno
Czechia	Regional Hospital Ceské Budejovice	Ceské Budejovice
Czechia	University hospital Hradec Králové	Hradec Kralove
Czechia	Regional Hospital Jihlava	Jihlava
Czechia	Regional Hospital Liberec	Liberec
Czechia	Nemocnice Pardubickeho kraje, a.s. - Pardubicka nemocnice	Pardubice
Czechia	Fakultní nemocnice Plzen	Pilsen
Czechia	Univ. Hospital Vinohrady	Prague
Czechia	Kardiologie Praha s.r.o.	Prague 10
Czechia	General Faculty Hospital	Prague 2
Czechia	Institutu Klinicke a Experimentalni Mediciny (IKEM) (Institute for Clinical and Experimental Medicine)	Prague 4
Czechia	Všeobecná fakultní nemocnice	Praha
Czechia	Kardiologie Vinohrady s.r.o.	Praha 1 - Nové Mesto
Czechia	Olomuc Cardiology	Prostejov
Czechia	University Hospital Ústí nad Labem	Ústí Nad Labem
Denmark	Aalborg University Hospital Cardiology	Aalborg
Denmark	Aarhus University Hospital	Aarhus
Denmark	Rigshospitalet	Copenhagen
Denmark	Esbjerg Hospital	Esbjerg
Denmark	Goedstrup Region Hospital	Herning
Denmark	Herning Hospital	Herning
Denmark	Odense Universitetshospital	Odense
Denmark	Zealand University Hospital	Roskilde
Denmark	Svendborg Hospital	Svendborg
Denmark	Viborg Hospital	Viborg
Estonia	The North Estonia Medical Centre	Tallinn
Estonia	Heart Clinic, Tartu University Hospital	Tartu
Finland	Jorvi Hospital, Helsinki University Hospital	Espoo
Finland	Heart and Lung Center, Helsinki University Hospital	Helsinki
Finland	North Karelian Central Hospital	Joensuu
Finland	StudyCor	Jyväskylä
Finland	Kokkola Central Hospital	Kokkola
Finland	Kuopio University Hospital	Kuopio
Finland	Oulu University Hospital	Oulu
Finland	Seinäjoki Central Hospital	Seinäjoki
Finland	TAYS Tutkimusvastaanotto / TAYS Research Center	Tampere
Finland	Heart Center, Turku University Hospital	Turku
France	CHRU Brest - Cavale Blanche	Brest
France	CHU Caen · Unité Cardiologie et Pathologie Vasculaire	Caen
France	Hospital Center Departmental Vendée	La Roche-sur-Yon
France	CH Chartres	Le Coudray
France	CHU Timone 2	Marseille
France	Clinique du Millénaire	Montpellier
France	Hôpital Arnaud de Villeneuve	Montpellier
France	Univ Hosp de Nimes Carémeau	Nîmes
France	Bichat-Claude Bernard Hospital	Paris
France	University Hospitals Pitié Salpêtrière	Paris
France	Hopital Cardiologique CHU Bordeaux	Pessac	Gironde
France	Nouvel Hopital Civil	Strasbourg
France	Hosp Rangueil - Cardiology A Dept	Toulouse
France	CHRU Nancy	Vandœuvre-lès-Nancy
Germany	Universitätsklinikum Freiburg; Universitäts-Herzzentrum Freiburg-Bad Krozingen	Bad Krozingen
Germany	Herz- und Diabeteszentrum NRW	Bad Oeynhausen
Germany	St. Johannes Hospital Dortmund	Dortmund
Germany	Herzzentrum Dresden GmbH; Universitätsklinik an der Technischen Universität Dresden	Dresden
Germany	Universitätsklinikum Hamburg Eppendorf	Hamburg
Germany	Krankenhaus der Augustinerinnen Köln gGmbH	Köln
Germany	Universitätsklinikum Köln	Köln
Germany	Herzzentrum Leipzig GmbH	Leipzig
Germany	Gesellschaft für Klinische Forschung mbH Ludwigshafen	Ludwigshafen
Germany	Uniklinikum Magdeburg A. ö. R.	Magdeburg
Germany	Universitätsmedizin Mannheim	Mannheim
Germany	München Klinik Neuperlach	München
Germany	Studienzentrum Innere Med. II Kardiologie, Universitätsklinikum Regensburg	Regensburg
Germany	Robert-Bosch Krankenhaus Stuttgart	Stuttgart
Germany	Krankenhaus der Barmherzigen Brüder	Trier
Germany	Universitätsklinikum Tübingen, Medizinische Klinik Innere Medizin III Kardiologie und Angiologie	Tübingen
Germany	Siteworks GmbH Prüfzentrum Völklingen	Völklingen
Greece	University General Hospital of Alexandroupolis	Alexandroupolis
Greece	General Hospital Hyppokration	Athens
Greece	University General Hospital "Attikon"	Athens
Greece	University Hospital of Heraklion	Heraklion
Greece	Thriasio General Hospital	Magoula
Greece	Sismanoglion General Hospital	Marousi
Greece	Konstantopouleio - Patision General Hospital of Nea Ionia	Nea Ionia
Greece	University Hospital of Patras	Patras
Greece	Aristotle University of Thessaloniki (AUTH) - University General Hospital of Thessaloniki (AHEPA)	Thessaloníki
Greece	General Hospital of Thessaloniki G.Papanikolaou	Thessaloníki
Greece	Asklepeion General Hospital, Voula	Voula
Hungary	Állami Szívkorhaz	Balatonfüred
Hungary	Betegápoló Irgalmasrend Budai Irgalmasrendi Kórház, Kardiológia	Budapest
Hungary	Gottsegen György Országos Kardiovaszkuláris Intézet	Budapest
Hungary	Magyar Honvédség Egészségügyi Központ	Budapest
Hungary	Semmelweis Egyetem Városmajori Szív- és Érgyógyászati Klinika Kardiológia	Budapest
Hungary	Uzsoki Utcai Kórház	Budapest
Hungary	Debreceni Egyetem Klinikai Központ Kardiológiai és Szívsebészeti Klinika	Debrecen
Hungary	Bács-Kiskun Megyei Kórház a Szegedi Tudományegyetem Általános Orvostudományi Kar Oktató Kórháza	Kecskemet
Hungary	Szegedi Tudományegyetem ÁOK Szent-Györgyi Albert Klinikai Központ II.sz. Belgyógyászati Klinika és Kardiológiai Központ	Szeged
Hungary	Jász-Nagykun-Szolnok Megyei Hetényi Géza Kórház-Rendelointézet	Szolnok
Hungary	Léda-Platán Magánklinika	Zalaegerszeg
Israel	Soroka University Medical Center	Beer-Sheva
Israel	Edith Wolfson Medical Center	H_olon
Israel	Hillel Yaffee Medical Center, Cardiology Department	Hadera
Israel	Bnai Zion Medical Center, Cardiology	Haifa
Israel	Rambam Health Care Campus	Haifa
Israel	Hadassah Hospital on Mount Scopus	Jerusalem
Israel	Shaare Zedek Medical Center, Cardiology Department	Jerusalem
Israel	Meir Medical Center	Kfar Sava
Israel	Galilee Medical Center	Nahariya
Israel	Rabin Medical Center	Petah tikva
Israel	Kaplan Medical Center, Intensive Cardiac Care Unit	Rehovot
Israel	Tel-Aviv Sourasky Medical Center	Tel Aviv
Israel	Leviev Heart Center, Sheba Medical Center	Tel Hashomer
Israel	Ziv Medical Center	Zefat
Israel	Shamir Medical Center (Assaf Harofeh)	Zerifin
Italy	San Donato Hospital, U.O.C. Cardiology	Arezzo
Italy	Ospedale Maggiore Bologna - Dept. Cardiology	Bologna
Italy	AORN Sant'Anna e San Sebastiano	Caserta
Italy	Azienda Ospedaliero-Universitaria Policlinico ""G. Rodolico - San Marco	Catania
Italy	AOU Mater Domini	Catanzaro
Italy	University Hospital of Ferrara, Cardiology Unit	Cona
Italy	"SOD Cardiologia Interventistica Strutturale, AOU Careggi	Firenze
Italy	Cardiologia - ASL5 - La Spezia	La Spezia
Italy	A.O.U. Policlinico Gaetano Martino	Messina
Italy	University of Naples "Federico II"	Napoli
Italy	AOU San Luigi Gonzaga Hospital	Orbassano
Italy	Ospedale Policlinico S. Matteo	Pavia
Italy	Azienda Ospedaliera di Perugia	Perugia
Italy	Azienda Ospedaliera di Perugia	Perugia
Italy	A.O.U.Città della Salute e della Scienza di Torino	Torino
Italy	Cardiology Department - Santa Chiara Hospital	Trento
Italy	Cardiology Department - Santa Chiara Hospital	Trento
Italy	Infermi Hospital in Rivoli (Turin)	Turin
Lithuania	Hospital of Lithuanian University of Health Sciences Kauno Klinikos	Kaunas
Lithuania	Klaipeda Seamen's Hospital	Klaipeda
Lithuania	Republican Panevezys Hospital	Panevezys
Lithuania	Vilnius University Hospital Santaros Klinikos	Vilnius
Netherlands	Jeroen Bosch Ziekenhuis	's-Hertogenbosch
Netherlands	Noordwest Ziekenhuisgroep	Alkmaar
Netherlands	Meander Medisch Centrum	Amersfoort
Netherlands	Amsterdam UMC	Amsterdam
Netherlands	Onze Lieve Vrouwe Gasthuis, locatie Oost	Amsterdam
Netherlands	Gelre Ziekenhuis Apeldoorn	Apeldoorn
Netherlands	Deventer Ziekenhuis	Deventer
Netherlands	Albert Schweitzer Ziekenhuis	Dordrecht
Netherlands	Gelderse Vallei Ziekenhuis	Ede
Netherlands	Catharina Hospital	Eindhoven
Netherlands	UMC Groningen	Groningen
Netherlands	Zuyderland Medical Center	Heerlen
Netherlands	Vasculair Onderzoek Centrum Hoorn	Hoorn
Netherlands	Medisch Centrum Leeuwarden	Leeuwarden
Netherlands	Canisius-Wilhelmina Ziekenhuis	Nijmegen
Netherlands	Radboud UMC	Nijmegen
Netherlands	Bravis Ziekenhuis	Roosendaal
Netherlands	Ziekenhuis Rivierenland	Tiel
Netherlands	Elisabeth-TweeSteden Ziekenhuis	Tilburg
Netherlands	Diakonessenhuis Utrecht	Utrecht
Netherlands	Máxima Medisch Centrum	Veldhoven
Norway	Akershus University Hospital	Lørenskog
Norway	Diakonhjemmet Hospital	Oslo
Norway	Oslo University Hospital Rikshospitalet	Oslo
Norway	Oslo University Hospital, Ullevål hospital	Oslo
Norway	Sykehuset Østfold Kalnes (Trust)	Sarpsborg
Norway	Vestfold Hospital	Tønsberg
Poland	Invasive Cardiology Department, University Teaching Hospital in Bialystok	Bialystok
Poland	Górnoslaskie Centrum Medyczne w Katowicach, III Oddzial Kardiologii	Katowice
Poland	Szpital Uniwersytecki w Krakowie, Oddzial Kliniczny Kardiologii oraz Interwencji Sercowo-Naczyniowych	Kraków
Poland	Miedziowe Centrum Zdrowia Regionalny, Osrodek Kardiologiczny, Pracownia Angiografii i Hemodynamiki	Lublin
Poland	Wojewódzki Szpital Specjalistyczny w Olsztynie, Oddzial Kardiologii	Olsztyn
Poland	Szpital Kliniczny im. Heliodora Swiecickiego Uniwersytetu Medycznego im. Karola Marcinkowskiego w Poznaniu	Poznan
Poland	Oddzial Kardiologii i intensywnej Terapii Kardiologicznej	Torun
Poland	Narodowy Instytut Kardiologii	Warsaw
Poland	Pracownia Kardiologii Inwazyjnej I Katedry i Kliniki Kardiologii Uniwersyteckiego Centrum Klinicznego Warszawskiego Uniwersytetu Medycznego	Warsaw
Poland	Uniwersytecki Szpital Kliniczny we Wroclawiu	Wroclaw
Poland	SCCS Zabrze I i II Oddzial Kardiologii i Angiologii	Zabrze
Romania	Spitalul Judetean de Urgenta ""Dr. Constantin Opris" Baia Mare	Baia Mare
Romania	Spitalul Judetean de Urgenta "Dr. Constantin Opris" Baia Mare	Baia Mare
Romania	County Clinical Emergency Hospital Brasov	Brasov
Romania	Spitalul Clinic de Urgenta Bucuresti	Bucharest
Romania	Niculae Stancioiu"" Heart Institute	Cluj-Napoca
Romania	Spitalul Clinic Judetean de Urgenta Cluj Napoca	Cluj-Napoca
Romania	Spitalul Judetean de Urgenta Satu Mare	Satu Mare
Romania	County Clinical Emergency Hospital Targu Mures	Targu Mures
Romania	Institute of Cardiovascular Diseases Timisoara	Timisoara
Serbia	Clin Hosp Ctr Zemun - Cardiology Dept	Belgrade
Serbia	Dedinje Cardiovascular Institute	Belgrade
Serbia	Department of Cardiology, Clinical Hospital Center Zemun	Belgrade
Serbia	Klinicko bolnicki centar "Zvezdara"	Belgrade
Serbia	Klinicko Bolnicki Centar Bežanijska Kosa	Belgrade
Serbia	Klinicko bolnicki centar, Bežanijska kosa	Belgrade
Serbia	University Clinical Center of Serbia	Belgrade
Serbia	University Clinical Center of Serbia (Department for Cardiovascular Disease Cardiology Clinic)	Belgrade
Serbia	University Clinical Center of Serbia (Diagnostic and Catheterization Lab)	Belgrade
Serbia	University Clinical Center of Serbia (Emergency Cardiology Services)	Belgrade
Serbia	University Hospital Centre Dr Dragiša Mišovic - Dedinje	Belgrade
Serbia	Klinicki centar Kragujevac	Kragujevac
Serbia	Opšta bolnica Leskovac	Leskovac
Serbia	Klinicki Centar Niš	Niš
Serbia	Institute of Cardiovascular Diseases, Vojvodina	Sremska Kamenica
Serbia	Opšta bolnica Užice	Užice
Serbia	Zdravstveni Centar Zajecar	Zajecar
Slovakia	Central Slovak Institute of Cardiovascular Diseases	Banska Bystrica
Slovakia	Cardiocentre CINRE	Bratislava
Slovakia	Premedix Clinic	Bratislava
Slovakia	University Hospital Bratislava	Bratislava
Slovakia	Východoslovenský ústav srdcových a cievnych chorôb	Košice
Slovakia	Kardiocentrum Nitra	Nitra
Spain	Hospital Universitari Germans Trias i Pujol	Badalona
Spain	Hospital Clinic. Barcelona	Barcelona
Spain	Hospital de La Santa Creu I Sant Pau	Barcelona
Spain	Hospital Universitario Virgen de la Arrixaca	El Palmar
Spain	Hospital Universitari de Bellvitge	L'Hospitalet De Llobregat
Spain	Hospital Clinico San Carlos	Madrid
Spain	Hospital Universitario Virgen de la Victoria	Málaga
Spain	Hospital Clinico Universitario de Santiago	Santiago De Compostela
Spain	Hospital Clinico Valencia	Valencia
Spain	Hospital Alvaro Cunqueiro, Cardiovascular Unit	Vigo
Switzerland	Universitätsspital Basel; Universitäres Herzzentrum	Basel
Switzerland	Inselspital, Universitäatspital Bern, Universitäatklinik für Kardiologie	Bern
Switzerland	Istituto Cardiocentro Ticino	Lugano
Switzerland	Kantonsspital St. Gallen	Saint Gallen
United Kingdom	Royal Papworth Hospital NHS Foundation Trust	Cambridge
United Kingdom	Altnagelvin Area Hospital (WHSCT)	Londonderry
United Kingdom	Freeman Hospital	Newcastle
United Kingdom	North Tyneside General Hospital, Northumbria Healthcare	North Shields
United Kingdom	Southern Health & Social Care Trust	Portadown
United Kingdom	Northern General Hospital	Sheffield
United Kingdom	Lister Hospital East and North Hertfordshire NHS Trust	Stevenage
United States	Advanced Cardiovascular, LLC	Alexander City	Alabama
United States	Amarillo Heart Clinical Research Institute Inc.	Amarillo	Texas
United States	PharmaTex Research	Amarillo	Texas
United States	Sinai Hospital Baltimore, LifeBridge Health	Baltimore	Maryland
United States	Northern Light Eastern Maine Medical Center	Bangor	Maine
United States	Birmingham VA Health Care System	Birmingham	Alabama
United States	Grandview Medical Center and Affinity Cardiovascular Specialists, LCC	Birmingham	Alabama
United States	University of Alabama at Birmingham	Birmingham	Alabama
United States	Grace Research, LLC	Bossier City	Louisiana
United States	Bay Area Cardiology Associates, P.A.	Brandon	Florida
United States	Advanced Heart Care, LLC	Bridgewater	New Jersey
United States	Wellspan Chambersburg Hospital	Chambersburg	Pennsylvania
United States	UVA University Hospital	Charlottesville	Virginia
United States	CHI Institute for Research and Innovation	Chattanooga	Tennessee
United States	Clearwater Cardiovascular Consultants	Clearwater	Florida
United States	University Hospitals Cleveland Medical Center	Cleveland	Ohio
United States	University of Missouri Healthcare	Columbia	Missouri
United States	John Muir Health	Concord	California
United States	Pioneer Clinical Studies (PCS)	Coral Gables	Florida
United States	Atlanta VA Medical Center	Decatur	Georgia
United States	Duke University Medical Center	Durham	North Carolina
United States	Inova Heart & Vascular Institute	Falls Church	Virginia
United States	Virginia Heart	Falls Church	Virginia
United States	Dignity Health Mercy Gilbert Medical Center	Gilbert	Arizona
United States	Endeavor Health	Glenview	Illinois
United States	Moses H. Cone Memorial Hospital Operation Corporation d/b/a Cone Health	Greensboro	North Carolina
United States	Prisma Health - Upstate	Greenville	South Carolina
United States	Upstate Cardiology	Greenville	South Carolina
United States	Penn State Health Milton S. Hershey Medical Center	Hershey	Pennsylvania
United States	Heart Center Research, LLC	Huntsville	Alabama
United States	Indiana University School of Medicine	Indianapolis	Indiana
United States	Baptist Health Research Institute	Jacksonville	Florida
United States	University of Florida Health Science Center at Jacksonville	Jacksonville	Florida
United States	Northeast Arkansas Charitable Foundation, Inc.- NEA Baptist Clinic	Jonesboro	Arkansas
United States	South Denver Cardiology Associates, PC	Littleton	Colorado
United States	St. Joseph's Hospital Cardiology	Liverpool	New York
United States	Long Beach VA Healthcare System	Long Beach	California
United States	University of Louisville	Louisville	Kentucky
United States	Baptist Clinical Research Institute	Memphis	Tennessee
United States	MidMichigan Medical Center - Mildland	Midland	Michigan
United States	Aurora St. Luke's Medical Center	Milwaukee	Wisconsin
United States	Indiana University Health Ball Memorial Hospital	Muncie	Indiana
United States	Vanderbilt University Medical Center	Nashville	Tennessee
United States	VA NY Harbor Healthcare System	New York	New York
United States	Christiana Care Health Services, Inc.	Newark	Delaware
United States	Saint Michael's Medical Center	Newark	New Jersey
United States	North Kansas City Hospital	North Kansas City	Missouri
United States	Covenant Medical Group d/b/a Parkway Cardiology Associates	Oak Ridge	Tennessee
United States	University of Oklahoma Health Sciences Center	Oklahoma City	Oklahoma
United States	Ascension Sacred Heart	Pensacola	Florida
United States	Baptist Hospital, Inc. d/b/a Baptist Hospital Cardiology	Pensacola	Florida
United States	OSF HealthCare Cardiovascular Institute	Peoria	Illinois
United States	Mayo Clinic Arizona	Phoenix	Arizona
United States	Cardiovascular Research of Knoxville	Powell	Tennessee
United States	Monument Health Clinical Research, Monument Health Rapid City Hospital Inc.	Rapid City	South Dakota
United States	Bon Secours St. Mary's Hospital of Richmond, LLC	Richmond	Virginia
United States	Reid Physician Associates	Richmond	Indiana
United States	Clearwater Cardiovascular Consultants	Safety Harbor	Florida
United States	Regions Hospital	Saint Paul	Minnesota
United States	San Francisco VA Health Care System"	San Francisco	California
United States	Adventist Healthcare White Oak Medical Center	Silver Spring	Maryland
United States	Lundquist Institute for Biomedical Innovation at Harbor - UCLA Medical Center	Torrance	California
United States	Cardiology Associates Research	Tupelo	Mississippi
United States	MedStar Washington Hospital Center	Washington	District of Columbia
United States	Interventional Cardiology Medical Group	West Hills	California
United States	Penn State Health Medical Group - Berks Cardiology	Wyomissing	Pennsylvania

Sponsors (1)

Lead Sponsor	Collaborator
Idorsia Pharmaceuticals Ltd.

Countries where clinical trial is conducted

United States,  Austria,  Belgium,  Bulgaria,  Canada,  China,  Czechia,  Denmark,  Estonia,  Finland,  France,  Germany,  Greece,  Hungary,  Israel,  Italy,  Lithuania,  Netherlands,  Norway,  Poland,  Romania,  Serbia,  Slovakia,  Spain,  Switzerland,  United Kingdom, 

References & Publications (2)

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. — View 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. — View Citation

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	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	Total duration: up to 7 days
Primary	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.	Total duration: up to 2 days
Secondary	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.	Total duration: up to 30 days