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

Idorsia Pharmaceuticals0 个研究点目标入组 1,680 人开始时间: 待定最近更新: 2024年4月15日

适应症

试验速览

暂无简介。

•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 1AMI (STEMI or 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 a second prior AMI within 1 year of screening or at
•least 2 of the following risk factors:
•- Second prior AMI more
•- 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

•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.

发起方

Idorsia Pharmaceuticals