Selatogrel Outcome Study in Suspected Acute Myocardial Infarction
Фаза 3 – широко изпитване преди одобрение
Заболявания:
Acute Myocardial Infarction
Спонсор: Viatris Innovation GmbH
Налично на:
БГ
Обобщение
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.
Описание
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.
Кой може да участва
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.
Места на провеждане
36
Австралия (1)
Royal Adelaide Hospital/ CNARTS
Adelaide
Белгия (1)
OLV Aalst
Aalst
Бразилия (1)
Hospital de Amor Barretos - Fundação PIO XII
Barretos
България (1)
Mbal Puls
Blagoevgrad
Канада (1)
University of Calgary Foothills Medical Centre
Calgary , Alberta
Chile (1)
Cec-Suecia
Santiago
Китай (1)
Baotou Central Hospital
Baotou
Чехия (1)
ICRC St. Anne University Hospital
Brno
Дания (1)
Aalborg University Hospital Cardiology
Aalborg
Estonia (1)
The North Estonia Medical Centre
Tallinn
Финландия (1)
Jorvi Hospital, Helsinki University Hospital
Espoo
Франция (1)
Hopital Cardiologique CHU Bordeaux
Pessac , Gironde
Georgia (1)
LTD High Technology Hospital Medcenter
Batumi
Гърция (1)
University General Hospital of Alexandroupolis
Alexandroupoli
Унгария (1)
Euréka-Center Bt.
Baja
Индия (1)
GCS Medical College, Hospital & Research Centre
Ahmedabad
Израел (1)
Soroka University Medical Center
Beersheba
Италия (1)
San Donato Hospital, U.O.C. Cardiology
Arezzo
Япония (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
Нидерландия (1)
Jeroen Bosch Ziekenhuis
's-Hertogenbosch
New Zealand (1)
Waikato Hospital
Hamilton
Норвегия (1)
Sørlandet Hospital Arendal
Arendal
Полша (1)
Invasive Cardiology Department, University Teaching Hospital in Białystok
Bialystok
Румъния (1)
Spitalul Judetean de Urgenta ""Dr. Constantin Opris" Baia Mare
Baia Mare
Сърбия (1)
Kliničko bolnički centar "Zvezdara"
Belgrade
Словакия (1)
Central Slovak Institute of Cardiovascular Diseases
Banská Bystrica
South Africa (1)
Iatros International
Bloemfontein
Южна Корея (1)
The Catholic University of Korea, Bucheon, St. Mary's Hospital