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: 18.1Level: PTClassification code 10014498Term: Embolic strokeSystem Organ Class: 10029205 - Nervous system disorders
Therapeutic area: Diseases [C] - Nervous System Diseases [C10]

Registration Number: EUCTR2013-000768-27-FI

Lead Sponsor: Bayer HealthCare AG

Brief Summary: Not available

Detailed Description: Not available

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 (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

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

Primary Outcome Measures

Name	Time	Method
Main Objective: The primary efficacy objective is to evaluate whether rivaroxaban is superior to aspirin in reducing the risk of recurrent stroke and systemic embolism in patients with a recent ESUS.;Secondary Objective: The secondary efficacy objective is to evaluate whether rivaroxaban is superior to aspirin in reducing cerebrovascular events, cardiovascular events, and mortality in patients with a recent ESUS.<br><br>The safety objective is to document the incidence of clinically relevant bleeding.;Primary end point(s): 1. Time from randomization to first occurrence of any of the components of the composite outcome (adjudicated), including:<br>• Stroke (ischemic, hemorrhagic, and undefined stroke, TIA with positive neuroimaging)<br>• Systemic embolism <br><br>2. Time from randomization to the first occurrence of major bleeding (International Society on Thrombosis and Haemostasis);Timepoint(s) of evaluation of this end point: Monitored throughout study

Secondary Outcome Measures

Name	Time	Method
Secondary end point(s): 1. Time from randomization to first occurrence of:<br>• Cardiovascular death (including death due to hemorrhage), recurrent stroke, systemic embolism, and myocardial infarction<br><br>2. Time from randomization to first occurrence of:<br>• All-cause mortality<br><br>3. Time from randomization to first occurrence of:<br>Individual components of the primary and secondary efficacy outcomes (stroke, CV death, and myocardial infarction) as well as ischemic stroke, and disabling stroke (modified Rankin score 4 and 5)<br><br>4. Time from randomization to the first occurrence of life-threatening bleeding <br><br>5. Time from randomization to the first occurrence of clinically relevant non-major bleeding<br><br>6. Time from randomization to the first occurrence of intracranial hemorrhage;Timepoint(s) of evaluation of this end point: Monitored throughout study

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