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 - SOS-AMI

Idorsia Pharmaceuticals Ltd0 sites14,000 target enrollmentStarted: February 14, 2023Last updated: February 26, 2024

Conditions

Trial Snapshot

No summary available.

•Signed and dated informed consent prior to any study-mandated procedure
•Male or female subject = 18 years old at the time of signing the informed consent form
•Discharged with a confirmed diagnosis of symptomatic Type 1 acute myocardial infarction ST-elevation myocardial infarction (STEMI) or Non-ST-elevation myocardial infarction (NSTEMI), 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 less-than 60 mL/min/1.73 m2,
•- Multivessel coronary artery disease,
•- Peripheral artery disease,
•- Age greater than or equal to 65 years,
•- Absence of coronary revascularization of the qualifying AMI,
•- Active daily smoking at screening.
•Successfully self-administered placebo according to the autoinjector Instructions for use during screening
•Are the trial subjects under 18? no
•Number of subjects for this age range:
•F.1.2 Adults (18-64 years) yes
•F.1.2.1 Number of subjects for this age range 5600
•F.1.3 Elderly (>=65 years) yes
•F.1.3.1 Number of subjects for this age range 8400

•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.
•Concomitant diseases or conditions 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.

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