Rivaroxaban versus Aspirin in secondary prevention of stroke and prevention of systemic embolism in patients with recent embolic stroke of undetermined source (ESUS)

Phase 1

• Conditions: Embolic stroke of undetermined source (ESUS); MedDRA version: 17.1Level: PTClassification code 10014498Term: Embolic strokeSystem Organ Class: 10029205 - Nervous system disorders; Therapeutic area: Diseases [C] - Nervous System Diseases [C10]

• Registration Number: EUCTR2013-000768-27-ES
• Lead Sponsor: Bayer HealthCare AG

Brief Summary

Not available

Detailed Description

Not available

Study Timeline

• Study Start: 2014-11-27
• Last Update Posted: 5 March 2018

Recruitment & Eligibility

• Status: ot Recruiting
• Sex: All
• Target Recruitment: 7000

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 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 2500
F.1.3 Elderly (>=65 years) yes
F.1.3.1 Number of subjects for this age range 4500

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

Study & Design

• Study Type: Interventional clinical trial of medicinal product
• Study Design: Not specified