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 个研究点目标入组 14,000 人开始时间: 2021年7月21日最近更新: 2024年4月15日

适应症

试验速览

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•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
•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
•Subject with 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
•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 m2;
•- Peripheral artery disease at any time prior to randomization;
•- Absence of, or unsuccessful coronary revascularization of the qualifying AMI.
•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.
•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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