Selatogrel Outcome Study in suspected Acute Myocardial Infarction (SOS-AMI) Multi-center, double-blind, randomized, placebo-controlled, parallel-group study to evaluate the efficacy and safety of self-administered subcutaneous selatogrel

The primary objective of the study is to assess the clinical efficacy of selatogrel when self-administered upon occurrence of symptoms suggestive of an acute myocardial infarction (AMI) in subjects at risk of having a recurrent AMI.

Inova Cardiology-Fairfax
8081 Innovation Park Drive, Suite 700
Fairfax, VA 22031

• Signed and dated informed consent prior to any study-mandated procedure
• Male or female subject ≥ 18 years old (or age of majority in local region) at the time of signing the ICF
• Discharged with a confirmed diagnosis of symptomatic type 1 AMI (STEMI or NSTEMI2), no longer than 4 weeks prior to randomization
• Presence of either a second prior AMI within 1 year of screening or at least 2 of the following risk factors:
  • Second prior AMI more than 1 year before screening
  • Diabetes mellitus defined by ongoing glucose lowering treatment
  • Chronic kidney disease with estimated glomerular filtration rate < 60 mL/min/1.73 m2
  • Multivessel coronary artery disease (≥ 50% stenosis in at least 2 coronary territories)
  • Peripheral artery disease defined as any of the following:
    • Ankle/brachial index < 0.85
    • Amputation, peripheral bypass, or peripheral angioplasty of the extremities secondary to ischemia
  • Age ≥ 65 years
  • Absence of coronary revascularization of the qualifying AMI referred to in inclusion criterion 3
  • Active daily smoking at screening
• Subject having successfully self-administered placebo according to the autoinjector IFU during screening
• Women of childbearing potential [see definition inSection 6.5] who fulfill the following criteria:
  • Negative pregnancy test (urine or serum) at randomization
  • Agreement to use an acceptable contraceptive method as described in Section 6.5.2 from screening up to the FSV

• 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
  • Subjects on oral triple antithrombotic therapy (i.e., dual antiplatelet therapy and oral anticoagulant)
  • Known liver impairment significantly affecting the hepatic function (e.g., ascites, icterus, signs ofcoagulopathy)
  • Current dialysis
  • Ischemic stroke or transient ischemic attack within3 months of screening
• Chronic anemia with hemoglobin < 10 g/dL
• Chronic thrombocytopenia with platelet count < 100,000/mm3
• Concomitant diseases (e.g., mental illness, significant cognitive deficits, neurodegenerative disease, terminal malignancy…) or conditions (e.g., inability to communicate well with the investigator in the local language, unwillingness to comply with study procedures/instructions, inability to understand the study-specific training, vulnerable subject…) that, in the opinion of the investigator, are not compatible with study participation
• 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
• Pregnant, planning to become pregnant, or lactating women
• Known concomitant life-threatening disease with a life expectancy < 12 months

Additional information can be found at https://clinicaltrials.gov/ct2/show/NCT04957719