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Selatogrel for Suspected Acute Myocardial Infarction

This study is looking into whether Selatogrel can help people who are at risk of having another heart attack (acute myocardial infarction or AMI). Selatogrel is a medication that you would give yourself using an autoinjector if you start having symptoms that suggest a heart attack. The study will compare Selatogrel to a placebo (an inactive substance that looks just like the study drug). You might be able to join if you are 18 or older, have recently had a type 1 heart attack, and have narrowing in multiple heart arteries. The researchers will be looking at your overall health status up to 7 days after treatment and checking for bleeding events up to 2 days after treatment. The current status of this study is unclear, and it plans to enroll 25,000 participants.

Study design
This is an interventional study comparing Selatogrel to a placebo, with a planned enrollment of 25,000 participants.
What's involved
Participants will self-administer either Selatogrel or placebo using an autoinjector when they experience symptoms of a heart attack.
Compensation
Not stated in the trial record.
Follow-up
Your clinical status will be assessed for up to 7 days, and bleeding events will be monitored for up to 2 days after treatment.

AI-generated from the public study record. Only the study team can confirm whether you're eligible — confirm details with them before making decisions.

NCT04957719

Selatogrel Outcome Study in Suspected Acute Myocardial Infarction

Enrolling by Invitation
PHASE3Ages 18+InterventionalTreatment
Viatris Innovation GmbH
~25,000 participants
Updated 2026-07-23 on ClinicalTrials.gov
What's tested:SelatogrelPlacebo

At a glance

Recruiting sites
0 of 821 listed sites are recruiting right now
RecruitingSuspended, closed, or not yet open
What they're measuring
Clinical status as assessed by a 6-point ordinal scale
Measured over Total duration: up to 7 days
+1 more outcome measured

Conditions

Acute Myocardial Infarction

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Acute Myocardial InfarctionChronic Kidney DiseaseCoronary Artery DiseaseDiabetes MellitusPeripheral Artery DiseasePURINERGIC RECEPTOR P2Y, G PROTEIN-COUPLED, 12

Where it's being run

821 sites across 78 states
China100
India79
Japan65
Poland33
Bulgaria28
Netherlands25
Brazil22
Germany22

Study leadership

  • Clinical Trials · STUDY_DIRECTOR · Viatris Innovation GmbH

Who to contact

This trial hasn't published a contact. View it on ClinicalTrials.gov

Do you actually qualify for this trial?

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Eligibility criteria

Inclusion

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.

Exclusion

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.
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.

What this trial measures

  • Clinical status as assessed by a 6-point ordinal scaleTotal duration: up to 7 days

    The clinical status will be assessed using a 6-point ordinal scale after any study treatment self-administration. Only the worst clinical outcome will be retained as the primary efficacy outcome. The 6 mutually exclusive outcomes ranked from worst to best are: 1. Death (all causes), within 7 days after study treatment administration. 2. Acute myocardial infarction with compromised electro-hemodynamics, within 2 days after study treatment administration. 3. ST-Elevation Myocardial Infarction (STEMI), within 2 days after study treatment administration. 4. High-risk Non-ST-Elevation Myocardial Infarction (NSTEMI), within 2 days after study treatment administration. 5. NSTEMI with peak cardiac troponin greater than 10 times upper limit of normal, within 2 days after study drug administration. 6. None of the above

  • Occurrence of Type 3 or 5 treatment-emergent bleeding events according to the Bleeding Academic Research Consortium (BARC) definitionTotal duration: up to 2 days

    The number of: * Type 3 treatment-emergent bleeding events and * Type 5 treatment-emergent bleeding events will be assessed according to the Bleeding Academic Research Consortium (BARC) definition (Mehran et al. 2011), within 2 days after study treatment administration. The Bleeding Academic Research Consortium (BARC) definitions are: * Type 3, bleeding is divided into 3 categories, a through c, and includes clinical, laboratory, and/or imaging evidence of bleeding with specific healthcare provider responses. * Type 5, bleeding is fatal.