Enrolling by invitation NCT04957719

Selatogrel Outcome Study in Suspected Acute Myocardial Infarction

Phase III Interventional Acute Myocardial Infarction

For patients and families

In plain language

An automatic summary of structured registry data. It is an orientation aid, not a substitute for the official protocol or a physician assessment.

What is being studied: The protocol lists: Selatogrel, Placebo.
Who it may be relevant to: Registry conditions: Acute Myocardial Infarction. Basic parameters: from 18 years · All.
What needs checking: Age, condition and sex are only basic indicators. Prior treatment, laboratory values and other mandatory requirements appear in the eligibility criteria below.
Where it takes place: United States, Australia, Austria, Belgium, Brazil +40
Next step: Save the trial, show it to the treating physician, and confirm current recruitment with the study center. Costs, documents and travel →

Unsure about the terms? Read our patient guide →

Official title

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

Overview

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

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.

Interventions

Combination product Selatogrel
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 pers
Combination product Placebo
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

Primary outcome measures

Clinical status as assessed by a 6-point ordinal scale [Time frame: 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 [Time frame: Total duration: up to 2 days]

Secondary outcome measures (1)

Occurrence of death, non-fatal acute myocardial infarction, hospitalization or unplanned emergency department visit for heart failure (Composite endpoint) [Time frame: Total duration: up to 30 days]

Eligibility criteria

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 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.

Criteria are shown verbatim from the registry (in English). Final eligibility is always assessed by the study center.

Healthy volunteers: No