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

Not Recruiting

Trial ID: NCT02313909

Age - 50 Years-N/A Gender - All Accepting Healthy Volunteers - No

Purpose

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.

Official 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

Stanford Investigator(s)

Nirali Vora
Nirali Vora

Clinical Professor, Neurology & Neurological Sciences

Eligibility


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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Intervention(s):

drug: Rivaroxaban (Xarelto, BAY59-7939)

other: Rivaroxaban-Placebo

other: Aspirin-Placebo

drug: Acetylsalicylic acid (Aspirin, BAY1019036)

Not Recruiting

Contact Information

Stanford University
School of Medicine
300 Pasteur Drive
Stanford, CA 94305
Madelleine Garcia
stroke center

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