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Selatogrel Outcome Study in Suspected Acute Myocardial Infarction

NCT04957719 · Status: ENROLLING_BY_INVITATION · Phase: PHASE3 · Type: INTERVENTIONAL · Enrollment: 25000

Last updated 2026-05-22

No results posted yet for this study

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.

Conditions

  • Acute Myocardial Infarction

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 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.

Sponsors & Collaborators

  • Viatris Innovation GmbH

    lead INDUSTRY

Principal Investigators

  • Clinical Trials · Viatris Innovation GmbH

Study Design

Allocation
RANDOMIZED
Purpose
TREATMENT
Masking
TRIPLE
Model
PARALLEL

Eligibility

Min Age
18 Years
Sex
ALL
Healthy Volunteers
No

Timeline & Regulatory

Start
2021-08-14
Primary Completion
2026-12-31
Completion
2026-12-31
FDA Drug
Yes
FDA Device
Yes

Countries

  • United States
  • Australia
  • Austria
  • Belgium
  • Brazil
  • Bulgaria
  • Canada
  • Chile
  • China
  • Czechia
  • Denmark
  • Estonia
  • Finland
  • France
  • Georgia
  • Germany
  • Greece
  • Hungary
  • India
  • Israel
  • Italy
  • Japan
  • Latvia
  • Lithuania
  • Malaysia
  • Netherlands
  • New Zealand
  • Norway
  • Philippines
  • Poland
  • Portugal
  • Romania
  • Serbia
  • Slovakia
  • South Africa
  • South Korea
  • Spain
  • Sweden
  • Switzerland
  • Taiwan
  • Thailand
  • United Kingdom

Study Locations

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Read the full study record

This page highlights key information. For complete eligibility criteria, study locations, investigator contacts, and the full protocol, visit the original record on ClinicalTrials.gov.

View NCT04957719 on ClinicalTrials.gov