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Search / Trial NCT04957719

Selatogrel Outcome Study in Suspected Acute Myocardial Infarction

Launched by IDORSIA PHARMACEUTICALS LTD. · Jul 7, 2021

Trial Information

Current as of June 26, 2025

Enrolling by invitation

Keywords

Platelet Aggregation Inhibitors

ClinConnect Summary

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.

Gender

ALL

Eligibility criteria

  • Main Inclusion Criteria:
  • Confirmed diagnosis of symptomatic type 1 acute myocardial infarction (AMI) ST-Elevation Myocardial Infarction (STEMI) or Non-ST-Elevation Myocardial Infarction (NSTEMI), no longer than 4 weeks prior to randomization.
  • * Diagnosis of multivessel coronary artery disease defined as ≥ 50% stenosis on 2 or more coronary artery territories, including the left main artery, during a prior cardiac catheterization or cardiac catheterization during the qualifying AMI event and presence of at least 1 of the following risk factors:
  • Second prior AMI,
  • Diabetes mellitus defined by ongoing glucose lowering treatment,
  • Chronic kidney disease defined as estimated glomerular filtration rate less than 60 mL/min/1.73 m2 and either known history of chronic kidney disease or a biomarker of chronic kidney damage,
  • Peripheral artery disease at any time prior to randomization,
  • Absence of, or unsuccessful coronary revascularization of the qualifying AMI.
  • Successful self-administered placebo according to the autoinjector instruction for use training during screening.
  • Main Exclusion Criteria:
  • * Increased risk of serious bleeding including any of the following:
  • History of intracranial bleed at any time.
  • Known uncorrected intracranial vascular abnormality.
  • Gastrointestinal bleed requiring hospitalization or transfusion within 1 year prior to screening.
  • Already on oral triple antithrombotic therapy (i.e., Dual antiplatelet therapy and oral anticoagulant).
  • Known liver impairment significantly affecting the hepatic function.
  • Current dialysis.
  • Ischemic stroke or transient ischemic attack within 3 months of screening.
  • Chronic anemia with hemoglobin \< 10 g/dL.
  • Chronic thrombocytopenia with platelet count \< 100,000/mm3.
  • Known hypersensitivity to selatogrel, any of its excipients, or drugs of the P2Y12 class.
  • Previous exposure to an investigational drug within 3 months prior to randomization.
  • Participation in another clinical trial with an investigational product or device within 3 months prior to randomization.

About Idorsia Pharmaceuticals Ltd.

Idorsia Pharmaceuticals Ltd. is a Swiss-based biopharmaceutical company dedicated to the discovery, development, and commercialization of innovative therapies for patients with high unmet medical needs. Founded in 2017, Idorsia leverages cutting-edge science and a robust pipeline to address various conditions, particularly in the fields of neurology, cardiovascular, and sleep medicine. With a commitment to fostering patient-centric solutions, the company aims to transform scientific advancements into meaningful treatments, guided by a strong emphasis on quality, integrity, and collaboration within the global healthcare community.

Locations

Ann Arbor, Michigan, United States

St. Paul, Minnesota, United States

Durham, North Carolina, United States

Indianapolis, Indiana, United States

Copenhagen, , Denmark

Edmonton, Alberta, Canada

Oklahoma City, Oklahoma, United States

Bangkok, , Thailand

Toronto, Ontario, Canada

Saint Paul, Minnesota, United States

Pomona, New Jersey, United States

Vancouver, British Columbia, Canada

Badalona, , Spain

Newark, Delaware, United States

Birmingham, Alabama, United States

Washington, District Of Columbia, United States

Louisville, Kentucky, United States

Ottawa, Ontario, Canada

Decatur, Georgia, United States

Newark, New Jersey, United States

Barcelona, , Spain

Madrid, , Spain

Edmonton, Alberta, Canada

Madrid, , Spain

Odense, , Denmark

Littleton, Colorado, United States

Edmonton, Alberta, Canada

Cambridge, Ontario, Canada

Lévis, Quebec, Canada

Santiago De Compostela, , Spain

Eindhoven, , Netherlands

Leeuwarden, , Netherlands

Kuopio, , Finland

Heidelberg, , Germany

Montpellier, , France

Oulu, , Finland

Hamburg, , Germany

Tel Aviv, , Israel

Jacksonville, Florida, United States

Sheffield, , United Kingdom

Edmonton, Alberta, Canada

Groningen, , Netherlands

Bad Oeynhausen, , Germany

La Jolla, California, United States

Athens, , Greece

Pensacola, Florida, United States

Milwaukee, Wisconsin, United States

Phoenix, Arizona, United States

Leipzig, , Germany

Viborg, , Denmark

New York, New York, United States

Patras, , Greece

Trier, , Germany

Stuttgart, , Germany

Petah Tikva, , Israel

Paris, , France

Belo Horizonte, , Brazil

Changsha, , China

Greenville, South Carolina, United States

Amarillo, Texas, United States

Pavia, , Italy

Nashville, Tennessee, United States

Hamilton, , New Zealand

Málaga, , Spain

Evanston, Illinois, United States

Huntsville, Alabama, United States

Bonheiden, , Belgium

Berlin, , Germany

Long Beach, California, United States

El Palmar, , Spain

Gdansk, , Poland

Halifax, Nova Scotia, Canada

Aguascalientes, , Mexico

Klaipeda, , Lithuania

Brno, , Czechia

Belgrade, , Serbia

Aarhus, , Denmark

'S Hertogenbosch, , Netherlands

Cleveland, Ohio, United States

Nanjing, Jiangsu, China

Esbjerg, , Denmark

Vilnius, , Lithuania

Songkhla, , Thailand

Gent, , Belgium

Mannheim, , Germany

Falls Church, Virginia, United States

North Kansas City, Missouri, United States

Ottawa, , Canada

Columbia, Missouri, United States

Concord, California, United States

Köln, , Germany

Treviso, , Italy

New York, New York, United States

Brandon, Florida, United States

Yangzhou, , China

Guangzhou, , China

Montréal, Quebec, Canada

Aalst, , Belgium

Wuhan, , China

Wuhan, , China

Daqing, , China

Zhengzhou, , China

Berlin, , Germany

Herning, , Denmark

Falls Church, Virginia, United States

Newark, New Jersey, United States

Shanghai, , China

Lørenskog, , Norway

Bossier City, Louisiana, United States

Nanjing, , China

Qingdao, , China

Wichita Falls, Texas, United States

Terrebonne, Quebec, Canada

Haifa, , Israel

Antwerp, , Belgium

Peoria, Illinois, United States

Chermside, , Australia

Beijing, , China

Clearwater, Florida, United States

Budapest, , Hungary

Berlin, , Germany

Edgewood, Kentucky, United States

Zefat, , Israel

Sofia, , Bulgaria

Belgrade, , Serbia

Bridgewater, New Jersey, United States

Heerlen, , Netherlands

Oslo, , Norway

Memphis, Tennessee, United States

Mar Del Plata, , Argentina

Nahariya, , Israel

Strasbourg, , France

Amarillo, Texas, United States

Hasselt, , Belgium

Peterborough, Ontario, Canada

Shanghai, , China

Alkmaar, , Netherlands

Deventer, , Netherlands

Duluth, Minnesota, United States

Alexander City, Alabama, United States

Svendborg, , Denmark

Belgrade, , Serbia

Fuzhou, , China

Xi'an, , China

Cali, , Colombia

Dortmund, , Germany

Wuppertal, , Germany

Hershey, Pennsylvania, United States

Turku, , Finland

Qingdao, , China

Amsterdam, , Netherlands

Changsha, Hunan, China

Amersfoort, , Netherlands

Tianjin, , China

Amsterdam, , Netherlands

Siegen, , Germany

Trois Rivières, Quebec, Canada

Vienna, , Austria

Belgrade, , Serbia

Portadown, , United Kingdom

Alexandroupolis, , Greece

Wrocław, , Poland

Oslo, , Norway

Changchun, , China

Zerifin, , Israel

Vandoeuvre Les Nancy, , France

Roskilde, , Denmark

Praha, , Czechia

Birmingham, Alabama, United States

Tupelo, Mississippi, United States

Saint Gallen, , Switzerland

Lugano, , Switzerland

Vandœuvre Lès Nancy, , France

Changsha, , China

Budapest, , Hungary

San Luis Potosí, , Mexico

Shanghai, , China

Shanghai, Shanghai, China

Karlsbad, , Germany

L'hospitalet De Llobregat, , Spain

Nijmegen, , Netherlands

Dordrecht, , Netherlands

Graz, , Austria

West Hills, California, United States

Safety Harbor, Florida, United States

Campinas, , Brazil

Bangor, Maine, United States

Cambridge, , United Kingdom

Kaohsiung City, , Taiwan

Tampa, Florida, United States

Greenville, South Carolina, United States

Ashdod, , Israel

Roosendaal, , Netherlands

Veldhoven, , Netherlands

Beijing, , China

Perugia, , Italy

Silver Spring, Maryland, United States

München, , Germany

Liaocheng, , China

Richmond, Indiana, United States

Aalborg, , Denmark

Heraklion, , Greece

Torrance, California, United States

Wuhan, , China

Kaunas, , Lithuania

Roeselare, , Belgium

Changchun, , China

Seinäjoki, , Finland

H̱olon, , Israel

Caserta, , Italy

Cambridge, , United Kingdom

Pensacola, Florida, United States

Leuven, , Belgium

Jacksonville, Florida, United States

Sankt Pölten, , Austria

Tallinn, , Estonia

São Paulo, , Brazil

Nanchang, , China

Amarillo, Texas, United States

Le Coudray, , France

Newmarket, Ontario, Canada

Powell, Tennessee, United States

Napoli, , Italy

Gilbert, Arizona, United States

Shanghai, , China

Tianjin, , China

Tønsberg, , Norway

Oslo, , Norway

Hefei, Anhui, China

Nijmegen, , Netherlands

Culiacán, , Mexico

Annecy, , France

Utrecht, , Netherlands

Yiyang, , China

Bad Oeynhausen, North Rhine Westphalia, Germany

Birmingham, Alabama, United States

Birmingham, Alabama, United States

Jonesboro, Arkansas, United States

San Francisco, California, United States

Miami, Florida, United States

Muncie, Indiana, United States

Baltimore, Maryland, United States

Midland, Michigan, United States

Liverpool, New York, United States

Williamsville, New York, United States

Greensboro, North Carolina, United States

Raleigh, North Carolina, United States

Chambersburg, Pennsylvania, United States

Wyomissing, Pennsylvania, United States

Rapid City, South Dakota, United States

Chattanooga, Tennessee, United States

Oak Ridge, Tennessee, United States

Charlottesville, Virginia, United States

Richmond, Virginia, United States

Klagenfurt, , Austria

Vienna, , Austria

Genk, , Belgium

Blagoevgrad, , Bulgaria

Burgas, , Bulgaria

Kardzhali, , Bulgaria

Pernik, , Bulgaria

Sandanski, , Bulgaria

Sofia, , Bulgaria

Calgary, Alberta, Canada

Brampton, Ontario, Canada

Montréal, Quebec, Canada

Montréal, Quebec, Canada

Brno, , Czechia

Jihlava, , Czechia

Pardubice, , Czechia

Prague 10, , Czechia

Prague 4, , Czechia

Prague, , Czechia

Praha 1 Nové Mesto, , Czechia

Prostějov, , Czechia

ústí Nad Labem, , Czechia

české Budějovice, , Czechia

Herning, , Denmark

Tartu, , Estonia

Espoo, , Finland

Helsinki, , Finland

Joensuu, , Finland

Jyväskylä, , Finland

Kokkola, , Finland

Brest, , France

Caen, , France

La Roche Sur Yon, , France

Marseille, , France

Montpellier, , France

Nîmes, , France

Paris, , France

Pessac, , France

Toulouse, , France

Bad Krozingen, , Germany

Bremen, , Germany

Dresden, , Germany

Köln, , Germany

Ludwigshafen, , Germany

Magdeburg, , Germany

Regensburg, , Germany

Tübingen, , Germany

Völklingen, , Germany

Budapest, , Hungary

Budapest, , Hungary

Budapest, , Hungary

Debrecen, , Hungary

Szeged, , Hungary

Zalaegerszeg, , Hungary

Dublin, , Ireland

Beer Sheva, , Israel

Hadera, , Israel

Haifa, , Israel

Jerusalem, , Israel

Jerusalem, , Israel

Kfar Sava, , Israel

Rehovot, , Israel

Tel Hashomer, , Israel

Arezzo, , Italy

Catania, , Italy

Catanzaro, , Italy

Cona, , Italy

Firenze, , Italy

La Spezia, , Italy

Messina, , Italy

Orbassano, , Italy

Perugia, , Italy

Trento, , Italy

Turin, , Italy

Panevezys, , Lithuania

Siauliai, , Lithuania

Apeldoorn, , Netherlands

Ede, , Netherlands

Hoorn, , Netherlands

Tiel, , Netherlands

Tilburg, , Netherlands

Venlo, , Netherlands

Sarpsborg, , Norway

Białystok, , Poland

Katowice, , Poland

Kraków, , Poland

Lublin, , Poland

Nowa Sól, , Poland

Olsztyn, , Poland

Poznań, , Poland

Toruń, , Poland

Warsaw, , Poland

Warsaw, , Poland

Zabrze, , Poland

Baia Mare, , Romania

Braşov, , Romania

Bucharest, , Romania

Bucharest, , Romania

Cluj Napoca, , Romania

Cluj Napoca, , Romania

Satu Mare, , Romania

Timişoara, , Romania

Târgu Mureş, , Romania

Belgrade, , Serbia

Belgrade, , Serbia

Belgrade, , Serbia

Belgrade, , Serbia

Belgrade, , Serbia

Kragujevac, , Serbia

Niš, , Serbia

Sremska Kamenica, , Serbia

Banska Bystrica, , Slovakia

Bratislava, , Slovakia

Bratislava, , Slovakia

Bratislava, , Slovakia

Barcelona, , Spain

Valencia, , Spain

Vigo, , Spain

Basel, , Switzerland

Bern, , Switzerland

Newcastle, , United Kingdom

North Shields, , United Kingdom

Stevenage, , United Kingdom

Beijing, , China

Hangzhou, , China

Taiyuan, , China

Jihlava, , Czechia

Londonderry, , United Kingdom

Poznań, , Poland

Vilnius, , Lithuania

Tianjin, , China

Belgrade, , Serbia

Belgrade, , Serbia

Portadown, , United Kingdom

Carmel, Indiana, United States

Campina Grande Do Sul, , Brazil

Pingxiang, , China

Tampere, , Finland

Pessac, Gironde, France

Salvador, , Brazil

New Plymouth, , New Zealand

Nanyang, , China

Belgrade, , Serbia

Belgrade, , Serbia

Belgrade, , Serbia

Houston, Texas, United States

Košice, , Slovakia

Martin, , Slovakia

Nitra, , Slovakia

Toronto, , Canada

Bologna, , Italy

Ann Arbor, Michigan, United States

Athens, , Greece

Gotse Delchev, , Bulgaria

Lovech, , Bulgaria

Sofia, , Bulgaria

Sofia, , Bulgaria

Tainan City, , Taiwan

Jinan, , China

Trois Rivières, Quebec, Canada

Changsha, , China

Dongcheng, , China

Hangzhou, , China

Hefei, , China

Hradec Kralove, , Czechia

Liberec, , Czechia

Pilsen, , Czechia

Prague 2, , Czechia

Balatonfüred, , Hungary

Kecskemet, , Hungary

Szolnok, , Hungary

Cluj Napoca, , Romania

Targu Mures, , Romania

Shanghai, , China

Shanghai, , China

Shenyang, , China

Nanjing, , China

Chengdu, , China

Heraklion, , Greece

Thessaloníki, , Greece

Thessaloníki, , Greece

Baia Mare, , Romania

Coral Gables, Florida, United States

Leskovac, , Serbia

Užice, , Serbia

Zaječar, , Serbia

Pensacola, Florida, United States

Glenview, Illinois, United States

Changsha, , China

Fuzhou, , China

Hefei, , China

Jihlava, , Czechia

Athens, , Greece

Magoula, , Greece

Marousi, , Greece

Nea Ionia, , Greece

Thessaloníki, , Greece

Voula, , Greece

Torino, , Italy

Pensacola, Florida, United States

Athens, , Greece

Marousi, , Greece

Kecskemét, , Hungary

Caserta, , Italy

Catania, , Italy

Bydgoszcz, , Poland

Lódz, , Poland

Poznan, , Poland

Wloclawek, , Poland

Wroclaw, , Poland

Cali, , Colombia

Tucson, Arizona, United States

Santiago, , Chile

Santiago, , Chile

Santiago, , Chile

Victoria, , Chile

Almada, , Portugal

Aveiro, , Portugal

Coimbra, , Portugal

Leiria, , Portugal

Lisboa, , Portugal

Midland, Michigan, United States

Buenos Aires, , Argentina

Buenos Aires, , Argentina

Corrientes, , Argentina

Córdoba, , Argentina

Quilmes, , Argentina

Trois Rivieres, , Canada

Victoria, , Chile

Berlin, , Germany

Nyíregyháza, , Hungary

Catania, , Italy

Ciudad De Mexico, , Mexico

Mexico City, , Mexico

Mexico City, , Mexico

Puebla, , Mexico

Queretaro, , Mexico

San Luis Potosí, , Mexico

Aveiro, , Portugal

Lisboa, , Portugal

Jinan, , China

Jinan, , China

Jining, , China

Linyi, , China

Nanjing, , China

Armenia, , Colombia

Bogota, , Colombia

Bogotá, , Colombia

Bogotá, , Colombia

Cali, , Colombia

Floridablanca, , Colombia

Medellin, , Colombia

Medellin, , Colombia

Medellín, , Colombia

Budapest, , Hungary

Belo Horizonte, , Brazil

Juiz De Fora, , Brazil

Jinan, , China

Jinan, , China

Nanchong, , China

Hellerup, , Denmark

łódź, , Poland

Phitsanulok, , Thailand

Trois Rivieres, , Canada

Tbilisi, , Georgia

Tbilisi, , Georgia

Tbilisi, , Georgia

Tbilisi, , Georgia

Tbilisi, , Georgia

Tbilisi, , Georgia

Saint Gallen, , Switzerland

Concord, , Australia

Hobart, , Australia

Jining, , China

Linyi, , China

Shijiazhuang, , China

Shijiazhuang, , China

Bydgoszcz, , Poland

Kaohsiung, , Taiwan

New Taipei City, , Taiwan

Golden, Colorado, United States

Wollongong, , Australia

Barretos, , Brazil

Campo Grande, , Brazil

Dalian, , China

Lianyungang, , China

Nanyang, , China

Shijiazhuang, , China

Tangshan, , China

Zibo, , China

Cluj Napoca, , Romania

Epping, , Australia

Milton, , Australia

St Albans, , Australia

Porto Alegre, , Brazil

Teresina, , Brazil

Guangdong, , China

Hangzhou, , China

Shaoxing, , China

Xinxiang, , China

Zhengzhou, , China

Patients applied

0 patients applied

Trial Officials

Clinical Trials

Study Director

Idorsia Pharmaceuticals Ltd.

Timeline

First submit

Trial launched

Trial updated

Estimated completion

Not reported

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