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By invitation only Phase 3 NCT04957719

Selatogrel Outcome Study in Suspected Acute Myocardial Infarction

Phase 3 – large-scale trial before approval
Conditions: Acute Myocardial Infarction

Sponsor: Viatris Innovation GmbH

trial.available_in: БГ
Overview
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.
Who can participate
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.
Locations 36
Australia (1)
Royal Adelaide Hospital/ CNARTS
Adelaide
Belgium (1)
OLV Aalst
Aalst
Brazil (1)
Hospital de Amor Barretos - Fundação PIO XII
Barretos
Bulgaria (1)
Mbal Puls
Blagoevgrad
Canada (1)
University of Calgary Foothills Medical Centre
Calgary , Alberta
Chile (1)
Cec-Suecia
Santiago
China (1)
Baotou Central Hospital
Baotou
Czech Republic (1)
ICRC St. Anne University Hospital
Brno
Denmark (1)
Aalborg University Hospital Cardiology
Aalborg
Estonia (1)
The North Estonia Medical Centre
Tallinn
Finland (1)
Jorvi Hospital, Helsinki University Hospital
Espoo
France (1)
Hopital Cardiologique CHU Bordeaux
Pessac , Gironde
Georgia (1)
LTD High Technology Hospital Medcenter
Batumi
Greece (1)
University General Hospital of Alexandroupolis
Alexandroupoli
Hungary (1)
Euréka-Center Bt.
Baja
India (1)
GCS Medical College, Hospital & Research Centre
Ahmedabad
Israel (1)
Soroka University Medical Center
Beersheba
Italy (1)
San Donato Hospital, U.O.C. Cardiology
Arezzo
Japan (1)
Hyogo Prefectural Amagasaki General Medical Center
Amagasaki-shi
Lithuania (1)
Hospital of Lithuanian University of Health Sciences Kauno Klinikos
Kaunas
Malaysia (1)
Hospital Raja Perempuan Zainab II
Kota Bharu
Netherlands (1)
Jeroen Bosch Ziekenhuis
's-Hertogenbosch
New Zealand (1)
Waikato Hospital
Hamilton
Norway (1)
Sørlandet Hospital Arendal
Arendal
Poland (1)
Invasive Cardiology Department, University Teaching Hospital in Białystok
Bialystok
Romania (1)
Spitalul Judetean de Urgenta ""Dr. Constantin Opris" Baia Mare
Baia Mare
Serbia (1)
Kliničko bolnički centar "Zvezdara"
Belgrade
Slovakia (1)
Central Slovak Institute of Cardiovascular Diseases
Banská Bystrica
South Africa (1)
Iatros International
Bloemfontein
South Korea (1)
The Catholic University of Korea, Bucheon, St. Mary's Hospital
Bucheon-si
Spain (1)
Hospital Universitari Germans Trias i Pujol
Badalona
Switzerland (1)
Universitätsspital Basel; Universitäres Herzzentrum
Basel
Taiwan (1)
Changhua Christian Hospital
Changhua
Thailand (1)
Bhumibol Adulyadej Hospital
Bangkok
United Kingdom (1)
Bradford Teaching Hospitals NHS Foundation Trust
Bradford
United States (1)
Advanced Cardiovascular, LLC
Alexander City , Alabama
Technical details
Status
By invitation only
Phase
Phase 3
Study type
INTERVENTIONAL
Sex
Male and female
Minimum age
18 Years
Healthy volunteers
No
Start date
14.08.2021
Completion date
01.12.2026
Registry ID
NCT04957719
Source
anzctr
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