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 infarctio

Phase 3

Recruiting

Conditions: heart attack
acute myocardial infarction
10028593

Registration Number: NL-OMON54126

Lead Sponsor: Idorsia Pharmaceuticals

Brief Summary: Not available

Detailed Description: Not available

Recruitment & Eligibility

Status: Recruiting

Sex: Not specified

Target Recruitment: 1680

Inclusion Criteria

• 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
and
• 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

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/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.