Rivaroxaban Versus Aspirin in Secondary Prevention of Stroke and Prevention of Systemic Embolism in Patients With Recent Embolic Stroke of Undetermined Source (ESUS)



Status:Terminated
Conditions:Cardiology, Neurology
Therapuetic Areas:Cardiology / Vascular Diseases, Neurology
Healthy:No
Age Range:50 - Any
Updated:1/11/2019
Start Date:December 23, 2014
End Date:February 15, 2018

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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:

- Recent ESUS (between 7 days and 6 months), defined as:

- Recent ischemic stroke (including transient ischemic attack with positive
neuroimaging) visualized by brain imaging that is not lacunar, and

- Absence of cervical carotid atherosclerotic stenosis> 50% or occlusion, and

- No atrial fibrillation after ≥ 24-hour cardiac rhythm monitoring, and

- No intra-cardiac thrombus on either transesophageal or transthoracic echocardiography,
and

- No other specific cause of stroke (for example, arteritis, dissection,
migraine/vasospasm, drug abuse)

Exclusion Criteria:

- Severely disabling stroke (modified Rankin score ≥4)

- Indication for chronic anticoagulation or antiplatelet therapy

- Estimated glomerular filtration rate (eGFR) < 30 mL/min/1.73 m^2
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