Selatogrel Outcome Study in Suspected Acute Myocardial Infarction

Open to people ages 18 years and up

• 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.

• 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.