Rivaroxaban Versus Aspirin in Secondary Prevention of Stroke and Prevention of Systemic Embolism in Patients With Recent Embolic Stroke of Undetermined Source (ESUS)

• Register: ClinicalTrials.gov
• Last refreshed on: 12 December 2020
• Main ID: NCT02313909
• Date of registration: 08/12/2014
• Prospective Registration: Yes
• Primary sponsor: Bayer
• Public title: Rivaroxaban Versus Aspirin in Secondary Prevention of Stroke and Prevention of Systemic Embolism in Patients With Recent Embolic Stroke of Undetermined Source (ESUS) NAVIGATE ESUS
• Scientific title: 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
• Date of first enrolment: December 23, 2014
• Target sample size: 7213
• Recruitment status: Terminated
• URL: https://clinicaltrials.gov/show/NCT02313909
• Study type: Interventional
• Study design: Allocation: Randomized. Intervention model: Parallel Assignment. Primary purpose: Prevention. Masking: Quadruple (Participant, Care Provider, Investigator, Outcomes Assessor).
• Phase: Phase 3

Countries of recruitment

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

Contacts

• Name: Bayer Study Director
• Affiliation: Bayer

Key inclusion & exclusion 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 either transesophageal or transthoracic echocardiography,
and

- No other specific cause of stroke (for example, arteritis, dissection,
migraine/vasospasm, drug abuse)

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 m^2



Age minimum: 50 Years
Age maximum: N/A
Gender: All

Health Condition(s) or Problem(s) studied

Stroke

Intervention(s)

Drug: Rivaroxaban (Xarelto, BAY59-7939)

Other: Rivaroxaban-Placebo

Other: Aspirin-Placebo

Drug: Acetylsalicylic acid (Aspirin, BAY1019036)

Primary Outcome(s)

Incidence Rate of a Major Bleeding Event According to the International Society on Thrombosis and Haemostasis (ISTH) Criteria (Adjudicated) [Time Frame: From randomization until the efficacy cut-off date (median 326 days)]

Incidence Rate of the Composite Efficacy Outcome (Adjudicated) [Time Frame: From randomization until the efficacy cut-off date (median 326 days)]

Secondary Outcome(s)

Incidence Rate of Any of the Following: Cardiovascular Death, Recurrent Stroke, Systemic Embolism and Myocardial Infarction [Time Frame: From randomization until the efficacy cut-off date (median 326 days)]

Incidence Rate of Life-Threatening Bleeding Events [Time Frame: From randomization until the efficacy cut-off date (median 326 days)]

Incidence Rate of Intracranial Hemorrhage [Time Frame: From randomization until the efficacy cut-off date (median 326 days)]

Incidence Rate of the Following: Stroke, Ischemic Stroke, Disabling Stroke, Cardiovascular (CV) Death, Myocardial Infarction [Time Frame: From randomization until the efficacy cut-off date (median 326 days)]

Incidence Rate of Clinically Relevant Non-Major Bleeding Events [Time Frame: From randomization until the efficacy cut-off date (median 326 days)]

Incidence Rate of All-Cause Mortality [Time Frame: From randomization until the efficacy cut-off date (median 326 days)]

Secondary ID(s)

16573

2013-000768-27

Source(s) of Monetary Support

Please refer to primary and secondary sponsors

Secondary Sponsor(s)

Population Health Research Institute

Janssen Research & Development, LLC

Results

• Results available: Yes
• Date Posted: 09/01/2019
• URL: https://clinicaltrials.gov/ct2/show/results/NCT02313909