Rivaroxaban Versus Aspirin in Secondary Prevention of Stroke and Prevention of Systemic Embolism in Patients With Recent Embolic Stroke of Undetermined Source (ESUS)
(NAVIGATE ESUS Trial)
Recruiting in Palo Alto (17 mi)
+372 other locations
Age: 18+
Sex: Any
Travel: May Be Covered
Time Reimbursement: Varies
Trial Phase: Phase 3
Waitlist Available
Sponsor: Bayer
No Placebo Group
Pivotal Trial (Near Approval)
Prior Safety Data
Trial Summary
What is the purpose of this trial?
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.
Eligibility Criteria
Inclusion Criteria
Recent ischemic stroke (including transient ischemic attack with positive neuroimaging) visualized by brain imaging that is not lacunar,
Absence of cervical carotid atherosclerotic stenosis> 50% or occlusion,
No atrial fibrillation after ≥ 24-hour cardiac rhythm monitoring,
See 2 more
Treatment Details
Interventions
- Acetylsalicylic acid (Aspirin, BAY1019036) (Antiplatelet Agent)
- Rivaroxaban (Anticoagulant)
Participant Groups
2Treatment groups
Experimental Treatment
Active Control
Group I: RivaroxabanExperimental Treatment2 Interventions
Rivaroxaban 15 mg orally once daily
Group II: AspirinActive Control2 Interventions
Aspirin 100 mg orally once daily
Find a Clinic Near You
Research Locations NearbySelect from list below to view details:
NCT02313909Baltimore, MD
NCT02313909Boston, MA
NCT02313909Worcester, MA
NCT02313909Ann Arbor, MI
More Trial Locations
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Who Is Running the Clinical Trial?
BayerLead Sponsor
Janssen Research & Development, LLCIndustry Sponsor
Population Health Research InstituteCollaborator