Selatogrel Outcome Study in Suspected Acute Myocardial Infarction (SOS-AMI)
M
Mohammed Madmani, MD
Primary Investigator
R
Rolf Kreutz, MD
Primary Investigator
Enrolling By Invitation
18 years and older
All
Phase
3
14000 participants needed
2 Locations
Brief description of study
This study will randomize patients recently discharged from the hospital with a confirmed
diagnosis of type 1 acute myocardial infarction (Thygesen et al. 2018) and having additionaldiovascular risk factors.
Detailed description of study
The purpose of this study is to assess the clinical efficacy of selatogrel whendministered upon occurrence of symptoms suggestive of an acute myocardial infarction
(AMI) in participants at risk of having a recurrent AMI.
Eligibility of study
You may be eligible for this study if you meet the following criteria:
- Conditions: Acute Myocardial Infarction
-
Age: 18 Years
-
Gender: All
Main Inclusion Criteria:
- Discharged with a confirmed diagnosis of symptomatic type 1 acute myocardial(AMI) ST-Elevation Myocardial Infarction (STEMI) or Non-ST-Elevationyocardial 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 thewing 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 60L/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.
- 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 yearg.
- Already on oral triple antithrombotic therapy (i.e., Dual antiplatelet therapyd 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.
- Known hypersensitivity to selatogrel, any of its excipients, or drugs of the P2Y12.
- Previous exposure to an investigational drug within 3 months prior to randomization.
- Participation in another clinical trial with an investigational product or devicewithin 3 months prior to randomization.
Updated on
01 Aug 2024.
Study ID: ID-076A301
Please visit our main page to search for other studies you may be interested in.
If you need help finding a study or have any questions, please contact us at inhealth@iu.edu
