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 study will enroll 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 (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.
-Ages Eligible for Study: 50 Years and older.
-Recent ESUS (between 7 days and 6 months).
-Severely disabling stroke (modified Rankin Score ≥4).
-Indication for chronic anticoagulation or antiplatelet therapy.
**Other protocol-defined inclusion/exclusion criteria may apply. Please click on the NCT Number (below) to learn more about the study at clinicaltrials.gov.**
Ted Lowenkopf, M.D.
- Providence Portland Medical Center
- Providence St. Vincent Medical Center