A Study to Learn How Well the Study Treatment Asundexian Works and How Safe it is Compared to Apixaban to Prevent Stroke or Systemic Embolism in People With Irregular and Often Rapid Heartbeat (Atrial Fibrillation), and at Risk for Stroke (OCEANIC-AF)

In by alicia.green

Locations
St. Augustine
Condition
Atrial Fibrillation, Heart Disease

A Study to Learn How Well the Study Treatment Asundexian Works and How Safe it is Compared to Apixaban to Prevent Stroke or Systemic Embolism in People With Irregular and Often Rapid Heartbeat (Atrial Fibrillation), and at Risk for Stroke (OCEANIC-AF)

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clinicaltrials.gov

Eligibility

Inclusion Criteria
  • 18 years of age or older (at legal age of consent according to local legislation) at the time of signing the informed consent
  • Atrial fibrillation documented by ECG evidence with an indication for indefinite treatment with an oral anticoagulant
  • CHA2DS2-VASc score ≥ 3 if male or ≥ 4 if female, OR CHA2DS2-VASc score of 2 if male or 3 if female and enrichment criteria.
Exclusion Criteria
  • Mechanical heart valve prosthesis
  • Moderate-to-severe mitral stenosis at the time of inclusion into the study
  • Atrial fibrillation only due to reversible cause
  • Requirement for chronic anticoagulation for a different indication than AF
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