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Selatogrel Outcome Study in Suspected Acute Myocardial Infarction

Enrolling By InvitationPhase 3

Sponsor: Viatris Innovation GmbH

Conditions: Acute Myocardial Infarction

Interventions: Selatogrel, Placebo

Countries: United States, Australia, Austria, Belgium, Brazil, Bulgaria, Canada, Chile

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.

Eligibility overview

Sex: ALL

Age: 18 Years to —

Healthy volunteers: No

Study type: INTERVENTIONAL

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, 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 (821)

Alexander City, Alabama, United States
Birmingham, Alabama, United States
Birmingham, Alabama, United States
Birmingham, Alabama, United States
Huntsville, Alabama, United States
Gilbert, Arizona, United States
Phoenix, Arizona, United States
Tucson, Arizona, United States
Anaheim, California, United States
Concord, California, United States
La Jolla, California, United States
San Francisco, California, United States
Santa Maria, California, United States
Torrance, California, United States
Van Nuys, California, United States
West Hills, California, United States
Golden, Colorado, United States
Littleton, Colorado, United States
Newark, Delaware, United States
Washington D.C., District of Columbia, United States
Boca Raton, Florida, United States
Brandon, Florida, United States
Clearwater, Florida, United States
Jacksonville, Florida, United States
Miami, Florida, United States
Pensacola, Florida, United States
Pensacola, Florida, United States
Safety Harbor, Florida, United States
Saint Augustine, Florida, United States
Columbus, Georgia, United States
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