EUCTR2013-000768-27-FI
Active, not recruiting
Phase 1
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 (NAVIGATE ESUS) - Secondary prevention of stroke in patients with ESUS
Overview
- Phase
- Phase 1
- Intervention
- Not specified
- Conditions
- Embolic stroke of undetermined source (ESUS)
- Sponsor
- Bayer HealthCare AG
- Enrollment
- 7000
- Status
- Active, not recruiting
- Last Updated
- 7 years ago
Overview
Brief Summary
No summary available.
Investigators
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 (at least 20 hours acceptable), 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)
- •Are the trial subjects under 18? no
- •Number of subjects for this age range:
- •F.1\.2 Adults (18\-64 years) yes
- •F.1\.2\.1 Number of subjects for this age range 3000
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
Outcomes
Primary Outcomes
Not specified
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