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"

Terminated

Phase 3 Results N/A

Eligibility Criteria

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 m2