Multicenter, Randomized, Double-blind, Double-dummy, Active-comparator, Event-driven, Superiority Phase III Study of Secondary Prevention of Stroke and Prevention of Systemic Embolism in Patients With a Recent Embolic Stroke of Undetermined Source (ESUS), Comparing Rivaroxaban 15 mg Once Daily With Aspirin 100 mg

Trial Profile

Multicenter, Randomized, Double-blind, Double-dummy, Active-comparator, Event-driven, Superiority Phase III Study of Secondary Prevention of Stroke and Prevention of Systemic Embolism in Patients With a Recent Embolic Stroke of Undetermined Source (ESUS), Comparing Rivaroxaban 15 mg Once Daily With Aspirin 100 mg

Discontinued
Phase of Trial: Phase III

Latest Information Update: 16 Oct 2017

At a glance

  • Drugs Rivaroxaban (Primary) ; Aspirin
  • Indications Embolism; Stroke
  • Focus Adverse reactions; Registrational; Therapeutic Use
  • Acronyms NAVIGATE ESUS
  • Sponsors Bayer
  • Most Recent Events

    • 14 Oct 2017 This trial has been completed in Belgium (End date: 2017-10-03).
    • 05 Oct 2017 Primary endpoint (Time from randomization to first occurrence of any of the components of the composite outcome (adjudicated), including: Stroke (ischemic, hemorrhagic, and undefined stroke, TIA with positive neuroimaging), Systemic embolism) has not been met, according to a Bayer media release.
    • 05 Oct 2017 Status changed from recruiting to discontinued according to a Janssen Research & Development media release.
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