Selatogrel Outcome Study in Suspected Acute Myocardial Infarction

Study Overview
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Brief Summary
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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.

Detailed Description
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The purpose of this study is to assess the clinical efficacy of selatogrel when self-administered upon occurrence of symptoms suggestive of an acute myocardial infarction (AMI) in participants at risk of having a recurrent AMI.

Official Title
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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 Infarction

Conditions
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Acute Myocardial Infarction

Intervention / Treatment
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* Combination Product: Selatogrel
* Combination Product: Placebo


Participation Criteria
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Eligibility Criteria
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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 or on the left main artery during a prior cardiac catheterization or cardiac catheterization during the qualifying AMI event and presence of at least 2 of the following risk factors: Second prior AMI, 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. 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 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.

Ages Eligible for Study
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Minimum Age: 18 Years

Sexes Eligible for Study
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All

Accepts Healthy Volunteers
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No

Study Plan
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How is the study designed?
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Design Details

Primary Purpose: Treatment
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Triple


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Experimental: Selatogrel<br>Study treatment administration may occur at any time between the randomization visit and the final study visit when the participant experiences symptoms suggestive of an acute myocardial infarction. Study treatment administration triggers protocol pre-defined assessments or visits. | Combination Product: Selatogrel<br>* Selatogrel is a reversible P2Y12 receptor antagonist for subcutaneous administration. Selatogrel will be administered as a liquid formulation in a sealed prefilled syringe in an autoinjector forming an integral ready-to-use, single-dose drug delivery system. Participants will self-administer 16 mg of selatogrel subcutaneously with the autoinjector upon occurrence of symptoms suggestive of an acute myocardial infarction. Self-administration encompasses the use of the autoinjector by another person (e.g., partner, close relative, friend, caregiver) who may be called for help during the emergency situation of a suspected AMI.<br>* Other names: ACT-246475;|
| Placebo Comparator: Placebo<br>Study treatment administration may occur at any time between the randomization visit and the final study visit when the participant experiences symptoms suggestive of an acute myocardial infarction. Study treatment administration triggers protocol pre-defined assessments or visits. | Combination Product: Placebo<br>* Placebo will be administered as a liquid formulation in a sealed prefilled syringe in an autoinjector forming an integral ready-to-use, single-dose drug delivery system. Participants will self-administer placebo subcutaneously with the autoinjector upon occurrence of symptoms suggestive of an acute myocardial infarction. Self-administration encompasses the use of the autoinjector by another person (e.g., partner, close relative, friend, caregiver) who may be called for help during the emergency situation of a suspected AMI.<br>|

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Clinical status as assessed by a 6-point ordinal scale | 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: Death (all causes), within 7 days after study treatment administration. Acute myocardial infarction with compromised electro-hemodynamics, within 2 days after study treatment administration. ST-Elevation Myocardial Infarction (STEMI), within 2 days after study treatment administration. High-risk Non-ST-Elevation Myocardial Infarction (NSTEMI), within 2 days after study treatment administration. NSTEMI with peak cardiac troponin greater than 10 times upper limit of normal, within 2 days after study drug administration. None of the above | Total duration: up to 7 days | 
| Occurrence of Type 3 or 5 treatment-emergent bleeding events according to the Bleeding Academic Research Consortium (BARC) definition | 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. | Total duration: up to 2 days | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Occurrence of death, non-fatal acute myocardial infarction, hospitalization or unplanned emergency department visit for heart failure (Composite endpoint) | Occurrence death, non-fatal acute myocardial infarction, hospitalization or unplanned emergency department visit for heart failure within 30 days after any self-administration. | Total duration: up to 30 days | 

 Terms related to the study
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Keywords Provided by Centre Hospitalier Valida
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Platelet Aggregation Inhibitors