Ensayos clínicos

Main Inclusion Criteria:

- 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 m^2,

- 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.

Main Exclusion Criteria:

- 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/mm^3.

- 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.

Note: Other protocol defined Inclusion/Exclusion Criteria may apply.

Eligibility last updated 10/17/23. Questions regarding updates should be directed to the study team contact.