NCT04957719

Selatogrel Outcome Study in Suspected Acute Myocardial Infarction

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

• Status: Enrolling By Invitation
• Phase: Phase 3
• Study type: Interventional
• Enrollment: 14,000 (estimated)
• Sponsor: Viatris Innovation GmbH · Industry
• Sex: All
• Age: 18 Years
• Healthy volunteers: Not accepted

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.

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.

Conditions

• Acute Myocardial Infarction

Interventions

Type	Name	Description
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 person (e.g., partner, close relative, friend, caregiver) who may be called for help during the emergency situation of a suspected AMI.
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 situation of a suspected AMI.

Timeline

• Start date: 2021-08-14
• Primary completion: 2026-12-01
• Completion: 2026-12-01
• First posted: 2021-07-12
• Last updated: 2026-03-19

Locations

716 sites across 39 countries: United States, Australia, Austria, Belgium, Brazil, Bulgaria, Canada, Chile, China, Czechia, Denmark, Estonia, Finland, France, Georgia, Germany, Greece, Hungary, India, Israel, Italy, Japan, Lithuania, Malaysia, Netherlands, New Zealand, Norway, Poland, Portugal, Romania, Serbia, Slovakia, South Africa, South Korea, Spain, Switzerland, Taiwan, Thailand, United Kingdom

Regulatory

• FDA-regulated drug study
• FDA-regulated device study