Trial Review

Did you know?

The ANZCTR now automatically displays published trial results and simplifies the addition of trial documents such as unpublished protocols and statistical analysis plans.

These enhancements will offer a more comprehensive view of trials, regardless of whether their results are positive, negative, or inconclusive.

The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been endorsed by the ANZCTR. Before participating in a study, talk to your health care provider and refer to this information for consumers
Trial details imported from ClinicalTrials.gov

For full trial details, please see the original record at https://clinicaltrials.gov/study/NCT04957719




Registration number
NCT04957719
Ethics application status
Date submitted
28/06/2021
Date registered
12/07/2021
Date last updated
6/11/2024

Titles & IDs
Public title
Selatogrel Outcome Study in Suspected Acute Myocardial Infarction
Scientific 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
Secondary ID [1] 0 0
2020-000983-41
Secondary ID [2] 0 0
ID-076A301
Universal Trial Number (UTN)
Trial acronym
SOS-AMI
Linked study record

Health condition
Health condition(s) or problem(s) studied:
Acute Myocardial Infarction 0 0
Condition category
Condition code
Cardiovascular 0 0 0 0
Coronary heart disease
Cardiovascular 0 0 0 0
Other cardiovascular diseases

Intervention/exposure
Study type
Interventional
Description of intervention(s) / exposure
Other interventions - Selatogrel
Other interventions - Placebo

Experimental: Selatogrel - 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.

Placebo comparator: Placebo - 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.


Other interventions: 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.

Other interventions: 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.
Intervention code [1] 0 0
Other interventions
Comparator / control treatment
Control group

Outcomes
Primary outcome [1] 0 0
Clinical status as assessed by a 6-point ordinal scale
Timepoint [1] 0 0
Total duration: up to 7 days
Primary outcome [2] 0 0
Occurrence of Type 3 or 5 treatment-emergent bleeding events according to the Bleeding Academic Research Consortium (BARC) definition
Timepoint [2] 0 0
Total duration: up to 2 days
Secondary outcome [1] 0 0
Occurrence of death, non-fatal acute myocardial infarction, hospitalization or unplanned emergency department visit for heart failure (Composite endpoint)
Timepoint [1] 0 0
Total duration: up to 30 days

Eligibility
Key inclusion criteria
Main

* 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
Minimum age
18 Years
Maximum age
No limit
Sex
Both males and females
Can healthy volunteers participate?
No
Key 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.

Study design
Purpose of the study
Treatment
Allocation to intervention
Randomised controlled trial
Procedure for enrolling a subject and allocating the treatment (allocation concealment procedures)
Methods used to generate the sequence in which subjects will be randomised (sequence generation)
Masking / blinding
Blinded (masking used)
Who is / are masked / blinded?
The people receiving the treatment/s
The people administering the treatment/s

The people analysing the results/data
Intervention assignment
Parallel
Other design features
Phase
Phase 3
Type of endpoint/s
Statistical methods / analysis

Recruitment
Recruitment status
Recruiting
Data analysis
Reason for early stopping/withdrawal
Other reasons
Date of first participant enrolment
Anticipated
Actual
14/08/2021
Date of last participant enrolment
Anticipated
Actual
Date of last data collection
Anticipated
13/08/2025
Actual
Sample size
Target
14000
Accrual to date
Final
Recruitment in Australia
Recruitment state(s)
Recruitment outside Australia
Country [1] 0 0
United States of America
State/province [1] 0 0
Alabama
Country [2] 0 0
United States of America
State/province [2] 0 0
Arizona
Country [3] 0 0
United States of America
State/province [3] 0 0
Arkansas
Country [4] 0 0
United States of America
State/province [4] 0 0
California
Country [5] 0 0
United States of America
State/province [5] 0 0
Colorado
Country [6] 0 0
United States of America
State/province [6] 0 0
Delaware
Country [7] 0 0
United States of America
State/province [7] 0 0
District of Columbia
Country [8] 0 0
United States of America
State/province [8] 0 0
Florida
Country [9] 0 0
United States of America
State/province [9] 0 0
Georgia
Country [10] 0 0
United States of America
State/province [10] 0 0
Illinois
Country [11] 0 0
United States of America
State/province [11] 0 0
Indiana
Country [12] 0 0
United States of America
State/province [12] 0 0
Kentucky
Country [13] 0 0
United States of America
State/province [13] 0 0
Louisiana
Country [14] 0 0
United States of America
State/province [14] 0 0
Maine
Country [15] 0 0
United States of America
State/province [15] 0 0
Maryland
Country [16] 0 0
United States of America
State/province [16] 0 0
Michigan
Country [17] 0 0
United States of America
State/province [17] 0 0
Minnesota
Country [18] 0 0
United States of America
State/province [18] 0 0
Mississippi
Country [19] 0 0
United States of America
State/province [19] 0 0
Missouri
Country [20] 0 0
United States of America
State/province [20] 0 0
New Jersey
Country [21] 0 0
United States of America
State/province [21] 0 0
New York
Country [22] 0 0
United States of America
State/province [22] 0 0
North Carolina
Country [23] 0 0
United States of America
State/province [23] 0 0
Ohio
Country [24] 0 0
United States of America
State/province [24] 0 0
Oklahoma
Country [25] 0 0
United States of America
State/province [25] 0 0
Pennsylvania
Country [26] 0 0
United States of America
State/province [26] 0 0
South Carolina
Country [27] 0 0
United States of America
State/province [27] 0 0
South Dakota
Country [28] 0 0
United States of America
State/province [28] 0 0
Tennessee
Country [29] 0 0
United States of America
State/province [29] 0 0
Texas
Country [30] 0 0
United States of America
State/province [30] 0 0
Virginia
Country [31] 0 0
United States of America
State/province [31] 0 0
Wisconsin
Country [32] 0 0
Argentina
State/province [32] 0 0
Buenos Aires
Country [33] 0 0
Argentina
State/province [33] 0 0
Corrientes
Country [34] 0 0
Argentina
State/province [34] 0 0
Córdoba
Country [35] 0 0
Argentina
State/province [35] 0 0
Mar del Plata
Country [36] 0 0
Argentina
State/province [36] 0 0
Quilmes
Country [37] 0 0
Austria
State/province [37] 0 0
Graz
Country [38] 0 0
Austria
State/province [38] 0 0
Klagenfurt
Country [39] 0 0
Austria
State/province [39] 0 0
Sankt Pölten
Country [40] 0 0
Austria
State/province [40] 0 0
Vienna
Country [41] 0 0
Belgium
State/province [41] 0 0
Aalst
Country [42] 0 0
Belgium
State/province [42] 0 0
Genk
Country [43] 0 0
Belgium
State/province [43] 0 0
Gent
Country [44] 0 0
Belgium
State/province [44] 0 0
Leuven
Country [45] 0 0
Belgium
State/province [45] 0 0
Roeselare
Country [46] 0 0
Brazil
State/province [46] 0 0
Campinas
Country [47] 0 0
Brazil
State/province [47] 0 0
São Paulo
Country [48] 0 0
Bulgaria
State/province [48] 0 0
Blagoevgrad
Country [49] 0 0
Bulgaria
State/province [49] 0 0
Burgas
Country [50] 0 0
Bulgaria
State/province [50] 0 0
Gotse Delchev
Country [51] 0 0
Bulgaria
State/province [51] 0 0
Kardzhali
Country [52] 0 0
Bulgaria
State/province [52] 0 0
Lovech
Country [53] 0 0
Bulgaria
State/province [53] 0 0
Pernik
Country [54] 0 0
Bulgaria
State/province [54] 0 0
Sandanski
Country [55] 0 0
Bulgaria
State/province [55] 0 0
Sofia
Country [56] 0 0
Canada
State/province [56] 0 0
Alberta
Country [57] 0 0
Canada
State/province [57] 0 0
Nova Scotia
Country [58] 0 0
Canada
State/province [58] 0 0
Ontario
Country [59] 0 0
Canada
State/province [59] 0 0
Quebec
Country [60] 0 0
Canada
State/province [60] 0 0
Montréal
Country [61] 0 0
Canada
State/province [61] 0 0
Ottawa
Country [62] 0 0
Canada
State/province [62] 0 0
Trois-Rivieres
Country [63] 0 0
Chile
State/province [63] 0 0
Santiago
Country [64] 0 0
Chile
State/province [64] 0 0
Victoria
Country [65] 0 0
China
State/province [65] 0 0
Beijing
Country [66] 0 0
China
State/province [66] 0 0
Changchun
Country [67] 0 0
China
State/province [67] 0 0
Changsha
Country [68] 0 0
China
State/province [68] 0 0
Chengdu
Country [69] 0 0
China
State/province [69] 0 0
Daqing
Country [70] 0 0
China
State/province [70] 0 0
Dongcheng
Country [71] 0 0
China
State/province [71] 0 0
Fuzhou
Country [72] 0 0
China
State/province [72] 0 0
Guangzhou
Country [73] 0 0
China
State/province [73] 0 0
Hangzhou
Country [74] 0 0
China
State/province [74] 0 0
Hefei
Country [75] 0 0
China
State/province [75] 0 0
Jinan
Country [76] 0 0
China
State/province [76] 0 0
Jining
Country [77] 0 0
China
State/province [77] 0 0
Linyi
Country [78] 0 0
China
State/province [78] 0 0
Nanjing
Country [79] 0 0
China
State/province [79] 0 0
Qingdao
Country [80] 0 0
China
State/province [80] 0 0
Shanghai
Country [81] 0 0
China
State/province [81] 0 0
Shenyang
Country [82] 0 0
China
State/province [82] 0 0
Tianjin
Country [83] 0 0
China
State/province [83] 0 0
Wuhan
Country [84] 0 0
China
State/province [84] 0 0
Xi'an
Country [85] 0 0
China
State/province [85] 0 0
YangZhou
Country [86] 0 0
China
State/province [86] 0 0
Zhengzhou
Country [87] 0 0
Colombia
State/province [87] 0 0
Armenia
Country [88] 0 0
Colombia
State/province [88] 0 0
Bogota
Country [89] 0 0
Colombia
State/province [89] 0 0
Bogotá
Country [90] 0 0
Colombia
State/province [90] 0 0
Cali
Country [91] 0 0
Colombia
State/province [91] 0 0
Floridablanca
Country [92] 0 0
Colombia
State/province [92] 0 0
Medellin
Country [93] 0 0
Colombia
State/province [93] 0 0
Medellín
Country [94] 0 0
Czechia
State/province [94] 0 0
Brno
Country [95] 0 0
Czechia
State/province [95] 0 0
Hradec Kralove
Country [96] 0 0
Czechia
State/province [96] 0 0
Jihlava
Country [97] 0 0
Czechia
State/province [97] 0 0
Liberec
Country [98] 0 0
Czechia
State/province [98] 0 0
Pardubice
Country [99] 0 0
Czechia
State/province [99] 0 0
Pilsen
Country [100] 0 0
Czechia
State/province [100] 0 0
Prague 10
Country [101] 0 0
Czechia
State/province [101] 0 0
Prague 2
Country [102] 0 0
Czechia
State/province [102] 0 0
Prague 4
Country [103] 0 0
Czechia
State/province [103] 0 0
Prague
Country [104] 0 0
Czechia
State/province [104] 0 0
Praha 1 - Nové Mesto
Country [105] 0 0
Czechia
State/province [105] 0 0
Praha
Country [106] 0 0
Czechia
State/province [106] 0 0
Prostejov
Country [107] 0 0
Czechia
State/province [107] 0 0
Ústí Nad Labem
Country [108] 0 0
Czechia
State/province [108] 0 0
Ceské Budejovice
Country [109] 0 0
Denmark
State/province [109] 0 0
Aalborg
Country [110] 0 0
Denmark
State/province [110] 0 0
Aarhus
Country [111] 0 0
Denmark
State/province [111] 0 0
Copenhagen
Country [112] 0 0
Denmark
State/province [112] 0 0
Esbjerg
Country [113] 0 0
Denmark
State/province [113] 0 0
Herning
Country [114] 0 0
Denmark
State/province [114] 0 0
Odense
Country [115] 0 0
Denmark
State/province [115] 0 0
Roskilde
Country [116] 0 0
Denmark
State/province [116] 0 0
Svendborg
Country [117] 0 0
Denmark
State/province [117] 0 0
Viborg
Country [118] 0 0
Estonia
State/province [118] 0 0
Tallinn
Country [119] 0 0
Estonia
State/province [119] 0 0
Tartu
Country [120] 0 0
Finland
State/province [120] 0 0
Espoo
Country [121] 0 0
Finland
State/province [121] 0 0
Helsinki
Country [122] 0 0
Finland
State/province [122] 0 0
Joensuu
Country [123] 0 0
Finland
State/province [123] 0 0
Jyväskylä
Country [124] 0 0
Finland
State/province [124] 0 0
Kokkola
Country [125] 0 0
Finland
State/province [125] 0 0
Kuopio
Country [126] 0 0
Finland
State/province [126] 0 0
Oulu
Country [127] 0 0
Finland
State/province [127] 0 0
Seinäjoki
Country [128] 0 0
Finland
State/province [128] 0 0
Tampere
Country [129] 0 0
Finland
State/province [129] 0 0
Turku
Country [130] 0 0
France
State/province [130] 0 0
Gironde
Country [131] 0 0
France
State/province [131] 0 0
Brest
Country [132] 0 0
France
State/province [132] 0 0
Caen
Country [133] 0 0
France
State/province [133] 0 0
La Roche-sur-Yon
Country [134] 0 0
France
State/province [134] 0 0
Le Coudray
Country [135] 0 0
France
State/province [135] 0 0
Marseille
Country [136] 0 0
France
State/province [136] 0 0
Montpellier
Country [137] 0 0
France
State/province [137] 0 0
Nîmes
Country [138] 0 0
France
State/province [138] 0 0
Paris
Country [139] 0 0
France
State/province [139] 0 0
Strasbourg
Country [140] 0 0
France
State/province [140] 0 0
Toulouse
Country [141] 0 0
France
State/province [141] 0 0
Vandœuvre-lès-Nancy
Country [142] 0 0
Germany
State/province [142] 0 0
Bad Krozingen
Country [143] 0 0
Germany
State/province [143] 0 0
Bad Oeynhausen
Country [144] 0 0
Germany
State/province [144] 0 0
Berlin
Country [145] 0 0
Germany
State/province [145] 0 0
Dortmund
Country [146] 0 0
Germany
State/province [146] 0 0
Dresden
Country [147] 0 0
Germany
State/province [147] 0 0
Hamburg
Country [148] 0 0
Germany
State/province [148] 0 0
Karlsbad
Country [149] 0 0
Germany
State/province [149] 0 0
Köln
Country [150] 0 0
Germany
State/province [150] 0 0
Leipzig
Country [151] 0 0
Germany
State/province [151] 0 0
Ludwigshafen
Country [152] 0 0
Germany
State/province [152] 0 0
Magdeburg
Country [153] 0 0
Germany
State/province [153] 0 0
Mannheim
Country [154] 0 0
Germany
State/province [154] 0 0
München
Country [155] 0 0
Germany
State/province [155] 0 0
Regensburg
Country [156] 0 0
Germany
State/province [156] 0 0
Stuttgart
Country [157] 0 0
Germany
State/province [157] 0 0
Trier
Country [158] 0 0
Germany
State/province [158] 0 0
Tübingen
Country [159] 0 0
Germany
State/province [159] 0 0
Völklingen
Country [160] 0 0
Germany
State/province [160] 0 0
Wuppertal
Country [161] 0 0
Greece
State/province [161] 0 0
Alexandroupolis
Country [162] 0 0
Greece
State/province [162] 0 0
Athens
Country [163] 0 0
Greece
State/province [163] 0 0
Heraklion
Country [164] 0 0
Greece
State/province [164] 0 0
Magoula
Country [165] 0 0
Greece
State/province [165] 0 0
Marousi
Country [166] 0 0
Greece
State/province [166] 0 0
Nea Ionia
Country [167] 0 0
Greece
State/province [167] 0 0
Patras
Country [168] 0 0
Greece
State/province [168] 0 0
Thessaloníki
Country [169] 0 0
Greece
State/province [169] 0 0
Voula
Country [170] 0 0
Hungary
State/province [170] 0 0
Balatonfüred
Country [171] 0 0
Hungary
State/province [171] 0 0
Budapest
Country [172] 0 0
Hungary
State/province [172] 0 0
Debrecen
Country [173] 0 0
Hungary
State/province [173] 0 0
Kecskemét
Country [174] 0 0
Hungary
State/province [174] 0 0
Nyíregyháza
Country [175] 0 0
Hungary
State/province [175] 0 0
Szeged
Country [176] 0 0
Hungary
State/province [176] 0 0
Szolnok
Country [177] 0 0
Hungary
State/province [177] 0 0
Zalaegerszeg
Country [178] 0 0
Israel
State/province [178] 0 0
Beer-Sheva
Country [179] 0 0
Israel
State/province [179] 0 0
Hadera
Country [180] 0 0
Israel
State/province [180] 0 0
Haifa
Country [181] 0 0
Israel
State/province [181] 0 0
H_olon
Country [182] 0 0
Israel
State/province [182] 0 0
Jerusalem
Country [183] 0 0
Israel
State/province [183] 0 0
Kfar Sava
Country [184] 0 0
Israel
State/province [184] 0 0
Nahariya
Country [185] 0 0
Israel
State/province [185] 0 0
Petah tikva
Country [186] 0 0
Israel
State/province [186] 0 0
Rehovot
Country [187] 0 0
Israel
State/province [187] 0 0
Tel Aviv
Country [188] 0 0
Israel
State/province [188] 0 0
Tel Hashomer
Country [189] 0 0
Israel
State/province [189] 0 0
Zefat
Country [190] 0 0
Israel
State/province [190] 0 0
Zerifin
Country [191] 0 0
Italy
State/province [191] 0 0
Arezzo
Country [192] 0 0
Italy
State/province [192] 0 0
Bologna
Country [193] 0 0
Italy
State/province [193] 0 0
Caserta
Country [194] 0 0
Italy
State/province [194] 0 0
Catania
Country [195] 0 0
Italy
State/province [195] 0 0
Catanzaro
Country [196] 0 0
Italy
State/province [196] 0 0
Cona
Country [197] 0 0
Italy
State/province [197] 0 0
Firenze
Country [198] 0 0
Italy
State/province [198] 0 0
Messina
Country [199] 0 0
Italy
State/province [199] 0 0
Napoli
Country [200] 0 0
Italy
State/province [200] 0 0
Orbassano
Country [201] 0 0
Italy
State/province [201] 0 0
Perugia
Country [202] 0 0
Italy
State/province [202] 0 0
Torino
Country [203] 0 0
Italy
State/province [203] 0 0
Trento
Country [204] 0 0
Italy
State/province [204] 0 0
Turin
Country [205] 0 0
Lithuania
State/province [205] 0 0
Kaunas
Country [206] 0 0
Lithuania
State/province [206] 0 0
Klaipeda
Country [207] 0 0
Lithuania
State/province [207] 0 0
Panevezys
Country [208] 0 0
Lithuania
State/province [208] 0 0
Vilnius
Country [209] 0 0
Mexico
State/province [209] 0 0
Aguascalientes
Country [210] 0 0
Mexico
State/province [210] 0 0
Ciudad de Mexico
Country [211] 0 0
Mexico
State/province [211] 0 0
Culiacán
Country [212] 0 0
Mexico
State/province [212] 0 0
Mexico City
Country [213] 0 0
Mexico
State/province [213] 0 0
Puebla
Country [214] 0 0
Mexico
State/province [214] 0 0
Queretaro
Country [215] 0 0
Mexico
State/province [215] 0 0
San Luis Potosí
Country [216] 0 0
Netherlands
State/province [216] 0 0
's-Hertogenbosch
Country [217] 0 0
Netherlands
State/province [217] 0 0
Alkmaar
Country [218] 0 0
Netherlands
State/province [218] 0 0
Amersfoort
Country [219] 0 0
Netherlands
State/province [219] 0 0
Amsterdam
Country [220] 0 0
Netherlands
State/province [220] 0 0
Apeldoorn
Country [221] 0 0
Netherlands
State/province [221] 0 0
Deventer
Country [222] 0 0
Netherlands
State/province [222] 0 0
Dordrecht
Country [223] 0 0
Netherlands
State/province [223] 0 0
Ede
Country [224] 0 0
Netherlands
State/province [224] 0 0
Eindhoven
Country [225] 0 0
Netherlands
State/province [225] 0 0
Groningen
Country [226] 0 0
Netherlands
State/province [226] 0 0
Heerlen
Country [227] 0 0
Netherlands
State/province [227] 0 0
Hoorn
Country [228] 0 0
Netherlands
State/province [228] 0 0
Leeuwarden
Country [229] 0 0
Netherlands
State/province [229] 0 0
Nijmegen
Country [230] 0 0
Netherlands
State/province [230] 0 0
Roosendaal
Country [231] 0 0
Netherlands
State/province [231] 0 0
Tiel
Country [232] 0 0
Netherlands
State/province [232] 0 0
Tilburg
Country [233] 0 0
Netherlands
State/province [233] 0 0
Utrecht
Country [234] 0 0
Netherlands
State/province [234] 0 0
Veldhoven
Country [235] 0 0
New Zealand
State/province [235] 0 0
Hamilton
Country [236] 0 0
New Zealand
State/province [236] 0 0
New Plymouth
Country [237] 0 0
Norway
State/province [237] 0 0
Lørenskog
Country [238] 0 0
Norway
State/province [238] 0 0
Oslo
Country [239] 0 0
Norway
State/province [239] 0 0
Sarpsborg
Country [240] 0 0
Norway
State/province [240] 0 0
Tønsberg
Country [241] 0 0
Poland
State/province [241] 0 0
Bialystok
Country [242] 0 0
Poland
State/province [242] 0 0
Bydgoszcz
Country [243] 0 0
Poland
State/province [243] 0 0
Gdansk
Country [244] 0 0
Poland
State/province [244] 0 0
Katowice
Country [245] 0 0
Poland
State/province [245] 0 0
Kraków
Country [246] 0 0
Poland
State/province [246] 0 0
Lublin
Country [247] 0 0
Poland
State/province [247] 0 0
Lódz
Country [248] 0 0
Poland
State/province [248] 0 0
Olsztyn
Country [249] 0 0
Poland
State/province [249] 0 0
Poznan
Country [250] 0 0
Poland
State/province [250] 0 0
Torun
Country [251] 0 0
Poland
State/province [251] 0 0
Warsaw
Country [252] 0 0
Poland
State/province [252] 0 0
Wloclawek
Country [253] 0 0
Poland
State/province [253] 0 0
Wroclaw
Country [254] 0 0
Poland
State/province [254] 0 0
Zabrze
Country [255] 0 0
Portugal
State/province [255] 0 0
Almada
Country [256] 0 0
Portugal
State/province [256] 0 0
Aveiro
Country [257] 0 0
Portugal
State/province [257] 0 0
Coimbra
Country [258] 0 0
Portugal
State/province [258] 0 0
Leiria
Country [259] 0 0
Portugal
State/province [259] 0 0
Lisboa
Country [260] 0 0
Romania
State/province [260] 0 0
Baia Mare
Country [261] 0 0
Romania
State/province [261] 0 0
Brasov
Country [262] 0 0
Romania
State/province [262] 0 0
Bucharest
Country [263] 0 0
Romania
State/province [263] 0 0
Cluj-Napoca
Country [264] 0 0
Romania
State/province [264] 0 0
Satu Mare
Country [265] 0 0
Romania
State/province [265] 0 0
Targu Mures
Country [266] 0 0
Romania
State/province [266] 0 0
Timisoara
Country [267] 0 0
Serbia
State/province [267] 0 0
Belgrade
Country [268] 0 0
Serbia
State/province [268] 0 0
Kragujevac
Country [269] 0 0
Serbia
State/province [269] 0 0
Leskovac
Country [270] 0 0
Serbia
State/province [270] 0 0
Niš
Country [271] 0 0
Serbia
State/province [271] 0 0
Sremska Kamenica
Country [272] 0 0
Serbia
State/province [272] 0 0
Užice
Country [273] 0 0
Serbia
State/province [273] 0 0
Zajecar
Country [274] 0 0
Slovakia
State/province [274] 0 0
Banska Bystrica
Country [275] 0 0
Slovakia
State/province [275] 0 0
Bratislava
Country [276] 0 0
Slovakia
State/province [276] 0 0
Košice
Country [277] 0 0
Slovakia
State/province [277] 0 0
Nitra
Country [278] 0 0
Spain
State/province [278] 0 0
Badalona
Country [279] 0 0
Spain
State/province [279] 0 0
Barcelona
Country [280] 0 0
Spain
State/province [280] 0 0
El Palmar
Country [281] 0 0
Spain
State/province [281] 0 0
L'Hospitalet De Llobregat
Country [282] 0 0
Spain
State/province [282] 0 0
Madrid
Country [283] 0 0
Spain
State/province [283] 0 0
Málaga
Country [284] 0 0
Spain
State/province [284] 0 0
Santiago De Compostela
Country [285] 0 0
Spain
State/province [285] 0 0
Valencia
Country [286] 0 0
Spain
State/province [286] 0 0
Vigo
Country [287] 0 0
Switzerland
State/province [287] 0 0
Basel
Country [288] 0 0
Switzerland
State/province [288] 0 0
Bern
Country [289] 0 0
Switzerland
State/province [289] 0 0
Lugano
Country [290] 0 0
Switzerland
State/province [290] 0 0
Saint Gallen
Country [291] 0 0
Taiwan
State/province [291] 0 0
Kaohsiung City
Country [292] 0 0
Thailand
State/province [292] 0 0
Bangkok
Country [293] 0 0
Thailand
State/province [293] 0 0
Songkhla
Country [294] 0 0
United Kingdom
State/province [294] 0 0
Cambridge
Country [295] 0 0
United Kingdom
State/province [295] 0 0
Londonderry
Country [296] 0 0
United Kingdom
State/province [296] 0 0
Newcastle
Country [297] 0 0
United Kingdom
State/province [297] 0 0
North Shields
Country [298] 0 0
United Kingdom
State/province [298] 0 0
Portadown
Country [299] 0 0
United Kingdom
State/province [299] 0 0
Sheffield
Country [300] 0 0
United Kingdom
State/province [300] 0 0
Stevenage

Funding & Sponsors
Primary sponsor type
Commercial sector/industry
Name
Idorsia Pharmaceuticals Ltd.
Address
Country

Ethics approval
Ethics application status

Summary
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.
Trial website
https://clinicaltrials.gov/study/NCT04957719
Trial related presentations / publications
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.
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.
Public notes

Contacts
Principal investigator
Name 0 0
Clinical Trials
Address 0 0
Idorsia Pharmaceuticals Ltd.
Country 0 0
Phone 0 0
Fax 0 0
Email 0 0
Contact person for public queries
Name 0 0
Address 0 0
Country 0 0
Phone 0 0
Fax 0 0
Email 0 0
Contact person for scientific queries



Summary Results

For IPD and results data, please see https://clinicaltrials.gov/study/NCT04957719