Secondary prevention of stroke in patients with ESUS

• Research type

  Research Study

• Full title

  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 (NAVIGATE ESUS)

• IRAS ID

  166537

• Contact name

  Keith Muir

• Contact email

  keith.muir@glasgow.ac.uk

• Sponsor organisation

  Bayer HealthCare AG

• Eudract number

  2013-000768-27

• Duration of Study in the UK

  2 years, 10 months, 19 days

• Research summary

  This is a study in patients who recently had a brain attack (stroke) and in whom no clear cause of the stroke could be identified. These strokes are likely due to a blood clot and therefore, can be called embolic stroke of undetermined source. The abbreviation is ESUS. The study will compare 2 blood thinners. Patients will be randomly assigned to either rivaroxaban 15 mg or aspirin 100 mg and the study is intended to show, if patients given rivaroxaban have fewer blood clots in the brain (stroke) or in other blood vessels.

• REC name

  West of Scotland REC 1

• REC reference

  14/WS/1146

• Date of REC Opinion

  26 Jan 2015

• REC opinion

  Further Information Favourable Opinion