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 for prevention of all-cause death and treatment of acute myocardial infarction in subjects with a recent history of acute myocardial infarction (20214069)

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

screening.

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.