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Selatogrel Outcome Study in suspected Acute Myocardial Infarction (SOS-AMI)

  • Status
    Accepting Candidates
  • Age
    18 Years - N/A
  • Sexes
  • Healthy Volunteers


Multi-center, double-blind, randomized, placebo-controlled, parallel-group study to evaluate the efficacy and safety of self-administered subcutaneous selatogrel for prevention of all-cause death and treatment of acute myocardial infarction in subjects with a recent history of acute myocardial infarction (20214069)


Protocol number 1318659


  1. Signed and dated informed consent prior to any study-mandated procedure;

  2. Male or female subject ≥ 18 years old (or age of majority in local region) at the time of signing the ICF;

  3. Confirmed diagnosis of symptomatic type 1 AMI (STEMI or NSTEMI9. , no longer than 4 weeks prior to randomization.

  4. 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:

a. Second prior AMI.

b. Diabetes mellitus defined by ongoing glucose lowering treatment.

c. Chronic kidney disease with estimated glomerular filtration rate

< 60 mL/min/1.73 m2.

d. PAD defined as any of the following at any time prior to randomization:

? Ankle/brachial index < 0.85.

? Amputation, peripheral bypass, or peripheral angioplasty of the extremities

secondary to ischemia.

e. Absence of, or unsuccessful coronary revascularization of the qualifying AMI

referred to in inclusion criterion 3.

  1. Subject having successfully self-administered placebo according to the autoinjector IFU during screening.

  2. Women of childbearing potential [see definition in Section 6. 5] must fulfill the

Following criteria:

– Negative pregnancy test (urine or serum) during screening. – Agreement to use an acceptable contraceptive method as described in Section 6.5.2

from screening up to the FSV.  

Exclusion Criteria:

  1. Increased risk of serious bleeding including any of the following: a. History of intracranial bleed at any time10. b. Known uncorrected intracranial vascular abnormality. c. Gastrointestinal bleed requiring hospitalization or transfusion within 1 year prior to screening. d. Subjects on oral triple antithrombotic therapy (i.e., DAPT and oral anticoagulant). e. Known liver impairment significantly affecting the hepatic function (e.g., ascites, icterus, signs of coagulopathy). f. Current dialysis. g. For all countries, except Finland: Ischemic stroke or transient ischemic attack within 3 months prior to screening.

For Finland: Ischemic stroke or transient ischemic attack within 1 year prior to


  1. Chronic anemia with hemoglobin < 10 g/dL.

  2. Chronic thrombocytopenia with platelet count < 100,000/mm3.

  3. 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.

  4. Known hypersensitivity to selatogrel, any of its excipients, or drugs of the P2Y12 class.

  5. Previous exposure to an investigational drug within 3 months prior to randomization.

  6. Participation in another clinical trial with an investigational product or device within 3 months prior to randomization.

  7. Pregnant, planning to become pregnant, or lactating women.

  8. Known concomitant life-threatening disease with a life expectancy < 12 months.

Lead researcher

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  1. Step

    Contact the research team

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    Primary contact

  2. Step

    Get screened to confirm eligibility

    You may be asked to take part in prescreening to make sure you are eligible for a study. The prescreening process ensures it is safe for you to participate. During the prescreening process, you will be asked some questions and you may also be asked to schedule tests or procedures to confirm your eligibility.

  3. Step

    Provide your consent to participate

    If you are eligible and want to join the clinical trial or study, a member of the research team will ask for your consent to participate. To give consent, you will be asked to read and sign a consent form for the study. This consent form explains the study's purpose, procedures, risks, benefits and provides other important information, such as the study team's contact information.

  4. Step


    If you decide to participate in a clinical trial or study, the research team will keep you informed of the study requirements and what you will need to do to throughout the study. For some trials or studies, your health care provider may work with the research team to ensure there are no conflicts with other medications or treatments.