Rivaroxaban versus Aspirin in secondary prevention of stroke and prevention of systemic embolism in patients with recent embolic stroke of undetermined source (ESUS)
- Conditions
- Embolic stroke of undetermined source (ESUS)MedDRA version: 19.0Level: PTClassification code 10014498Term: Embolic strokeSystem Organ Class: 10029205 - Nervous system disordersTherapeutic area: Diseases [C] - Nervous System Diseases [C10]
- Registration Number
- EUCTR2013-000768-27-DK
- Lead Sponsor
- Bayer AG
- Brief Summary
Not available
- Detailed Description
Not available
Recruitment & Eligibility
- Status
- ot Recruiting
- Sex
- All
- Target Recruitment
- 7000
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
F.1.3 Elderly (>=65 years) yes
F.1.3.1 Number of subjects for this age range 4000
• 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
Study & Design
- Study Type
- Interventional clinical trial of medicinal product
- Study Design
- Not specified
- Primary Outcome Measures
Name Time Method
- Secondary Outcome Measures
Name Time Method