Selatogrel Outcome Study in Suspected Acute Myocardial Infarction (NCT04957719) | Clinical Trial Compass
By InvitationPhase 3
Selatogrel Outcome Study in Suspected Acute Myocardial Infarction
United States, Australia, Austria25,000 participantsStarted 2021-08-14
Plain-language summary
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 additional cardiovascular risk factors.
Who can participate
Age range
18 Years
Sex
ALL
See this in plain English?
AI-rewrites the medical criteria so a patient or caregiver can understand them. Always confirm with the trial site.
Main Inclusion Criteria:
* Confirmed diagnosis of symptomatic type 1 acute myocardial infarction (AMI) ST-Elevation Myocardial Infarction (STEMI) or Non-ST-Elevation Myocardial Infarction (NSTEMI), no longer than 4 weeks prior to randomization.
* Diagnosis of multivessel coronary artery disease defined as ≥ 50% stenosis on 2 or more coronary artery territories, during a prior cardiac catheterization or cardiac catheterization during the qualifying AMI event and presence of at least 1 of the following risk factors:
* Second prior AMI,
* Diabetes mellitus defined by ongoing glucose lowering treatment,
* Chronic kidney disease defined as estimated glomerular filtration rate less than 60 mL/min/1.73 m2 and either known history of chronic kidney disease or a biomarker of chronic kidney damage,
* Peripheral artery disease at any time prior to randomization,
* Absence of, or unsuccessful coronary revascularization of the qualifying AMI.
* 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 year prior to screening.
* Already on oral triple antithrombotic therapy (i.e., Dual antiplatelet therapy and oral anticoagulant).
* Known liver i…
Questions worth asking your doctor
Bring these to your next appointment. They're a starting point for a shared conversation — not a sign you qualify or a recommendation to enrol.
1This is a Phase 3 trial testing selatogrel for suspected heart attacks — since it's Phase 3, there should be more safety data than earlier studies, but what do we actually know so far about how safe and effective selatogrel is compared to what I'd receive with standard treatment?
2The trial is measuring bleeding events using something called the BARC scale — given my personal medical history, how concerned should I be about serious bleeding as a risk if I were to participate in this study?
3The study is 'enrolling by invitation only' — what would it mean for my care if I'm not invited or don't qualify, and would I still have access to the best available treatments outside of the trial?
4The trial tracks patient outcomes using a 6-point scale of clinical status after a suspected heart attack — can you explain what outcomes that scale is measuring and how the results of this study might eventually change how heart attacks are treated?
5Since this trial involves a suspected acute heart attack, which can require fast decisions, how would joining this study affect the speed or type of emergency care I'd receive, and is there a scenario where standard care might be a safer or more straightforward path for me?
Generated to help you prepare — always confirm anything about your own eligibility and care with the study team and your doctor.
Questions for the trial coordinator
The trial coordinator is the person who runs the study day to day. These cover the practical side — logistics, costs, and what taking part would actually mean for your life. The study team confirms whether you meet the criteria; these are questions to ask, not a sign you qualify.
1What does taking part actually involve week to week — how many visits, where, and how long does each one take?
2What costs are covered by the study, and what might I have to pay for myself, including travel, parking, or time off work?
3What happens during screening, and what happens if the study team confirms I don't meet the criteria after those tests?
4Who pays for the scans, blood work, and other tests the trial requires — the study, my insurance, or me?
5How will being in the trial affect my regular care, and will my own doctor stay informed and involved?
6Can I leave the trial at any point if I change my mind, and what would happen to my care if I do?
A starting point for the conversation — always confirm anything about your own eligibility, costs, and care with the study team and your doctor.
What they're measuring
1
Clinical status as assessed by a 6-point ordinal scale
Timeframe: Total duration: up to 7 days
2
Occurrence of Type 3 or 5 treatment-emergent bleeding events according to the Bleeding Academic Research Consortium (BARC) definition