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

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

Status

Active, not recruiting

Phases

Phase 3

Study type

Interventional

Source

EU CTR

Registry ID

EUCTR2013-000768-27-SE

Enrollment

7000

Registered

2014-09-22

Start date

2015-01-29

Completion date

Unknown

Last updated

2017-11-13

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

Embolic stroke of undetermined source (ESUS) MedDRA version: 17.0 Level: PT Classification code 10014498 Term: Embolic stroke System Organ Class: 10029205 - Nervous system disorders

Interventions

Trade Name: Xarelto 15 mg film-coated tablets Product Name: Rivaroxaban 15 mg Product Code: BAY 59-7939 Pharmaceutical Form: Film-coated tablet INN or Proposed INN: RIVAROXABAN CAS Number: 366789-02-

Eligibility

Sex/Gender

All

Inclusion 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 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

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

Design outcomes

Primary

Measure	Time frame
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. 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: • Stroke (ischemic, hemorrhagic, and undefined stroke, TIA with positive neuroimaging) • Systemic embolism 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	—

Measure

Time frame

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. 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: • Stroke (ischemic, hemorrhagic, and undefined stroke, TIA with positive neuroimaging) • Systemic embolism 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

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Secondary

Measure	Time frame
Secondary end point(s): 1. Time from randomization to first occurrence of: • Cardiovascular death (including death due to hemorrhage), recurrent stroke, systemic embolism, and myocardial infarction 2. Time from randomization to first occurrence of: • All-cause mortality 3. Time from randomization to first occurrence of: 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) 4. Time from randomization to the first occurrence of life-threatening bleeding 5. Time from randomization to the first occurrence of clinically relevant non-major bleeding 6. Time from randomization to the first occurrence of intracranial hemorrhage;Timepoint(s) of evaluation of this end point: Monitored throughout study	—

Measure

Time frame

Secondary end point(s): 1. Time from randomization to first occurrence of: • Cardiovascular death (including death due to hemorrhage), recurrent stroke, systemic embolism, and myocardial infarction 2. Time from randomization to first occurrence of: • All-cause mortality 3. Time from randomization to first occurrence of: 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) 4. Time from randomization to the first occurrence of life-threatening bleeding 5. Time from randomization to the first occurrence of clinically relevant non-major bleeding 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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Countries

Argentina, Australia, Austria, Belgium, Brazil, Canada, Chile, China, Czech Republic, Denmark, Finland, France, Germany, Greece, Hungary, Ireland, Italy, Japan, Korea, Republic of, Mexico, Poland, Portugal, Russian Federation, South Africa, Spain, Sweden, Switzerland, United Kingdom, United States

Contacts

Public ContactBayer Clinical Trials Contact

Bayer HealthCare AG

clinical-trials-contact@bayerhealthcare.com

Outcome results

None listed

Source: EU CTR (via WHO ICTRP) · Data processed: Feb 4, 2026