Selatogrel Outcome Study in Suspected Acute Myocardial Infarctio

Phase 1

• Conditions: Acute myocardial infarction; MedDRA version: 20.0Level: PTClassification code 10000891Term: Acute myocardial infarctionSystem Organ Class: 10007541 - Cardiac disorders; Therapeutic area: Diseases [C] - Cardiovascular Diseases [C14]

• Registration Number: EUCTR2020-000983-41-ES
• Lead Sponsor: Idorsia Pharmaceuticals Ltd

Brief Summary

Not available

Detailed Description

Not available

Study Timeline

• Results First Posted: 1900-01-01
• Study Start: 2021-07-09
• Last Update Posted: 8 October 2021

Recruitment & Eligibility

• Status: Authorised-recruitment may be ongoing or finished
• Sex: All
• Target Recruitment: 14000

Inclusion Criteria

• Signed and dated informed consent prior to any study-mandated procedure
• Male or female subject > or = 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

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.

Study & Design

• Study Type: Interventional clinical trial of medicinal product
• Study Design: Not specified