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
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
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.
Inclusion Criteria:
Exclusion Criteria:
Ciudad Auton. de Buenos Aires, Buenos Aires C1405CNF, Argentina
Ciudad Auton. de Buenos Aires, C1425DND, Argentina
Bruxelles - Brussel, 1070, Belgium
Valdivia, Los Lagos Region, Chile
Ostrava Vitkovice, Czechia
Ostrava-Poruba, 708 52, Czechia
OYS, 90029, Finland
Sairaalamäki, 45750, Finland
Bunkyo-ku, Tokyo 113-8603, Japan
Shinjuku-ku, Tokyo 162-8666, Japan
Sumida-ku, Tokyo 130-8575, Japan
México D.F., México 06720, Mexico
México D.F., Mexico
Vilanova de Gaia, Porto District 4434-502, Portugal