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Trial details imported from ClinicalTrials.gov
For full trial details, please see the original record at
https://clinicaltrials.gov/ct2/show/NCT02313909
Registration number
NCT02313909
Ethics application status
Date submitted
8/12/2014
Date registered
10/12/2014
Date last updated
9/01/2019
Titles & IDs
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)
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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
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Secondary ID [1]
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0
2013-000768-27
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Secondary ID [2]
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0
16573
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Universal Trial Number (UTN)
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Trial acronym
NAVIGATE ESUS
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Linked study record
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Health condition
Health condition(s) or problem(s) studied:
Stroke
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0
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Condition category
Condition code
Stroke
0
0
0
0
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Haemorrhagic
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Stroke
0
0
0
0
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Ischaemic
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Cardiovascular
0
0
0
0
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Diseases of the vasculature and circulation including the lymphatic system
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Blood
0
0
0
0
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Clotting disorders
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Intervention/exposure
Study type
Interventional
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Description of intervention(s) / exposure
Treatment: Drugs - Rivaroxaban (Xarelto, BAY59-7939)
Treatment: Drugs - Acetylsalicylic acid (Aspirin, BAY1019036)
Other interventions - Rivaroxaban-Placebo
Other interventions - Aspirin-Placebo
Experimental: Rivaroxaban - Rivaroxaban 15 mg orally once daily
Active Comparator: Aspirin - Aspirin 100 mg orally once daily
Treatment: Drugs: Rivaroxaban (Xarelto, BAY59-7939)
15 mg, once daily, orally, tablet
Treatment: Drugs: Acetylsalicylic acid (Aspirin, BAY1019036)
100 mg, once daily, orally, tablet
Other interventions: Rivaroxaban-Placebo
Matching placebo, once daily, orally, tablet
Other interventions: Aspirin-Placebo
Matching placebo, once daily, orally, tablet
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Intervention code [1]
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Treatment: Drugs
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Intervention code [2]
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Other interventions
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Comparator / control treatment
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Control group
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Outcomes
Primary outcome [1]
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Incidence Rate of the Composite Efficacy Outcome (Adjudicated)
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Assessment method [1]
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Components of composite efficacy outcome (adjudicated) includes stroke (ischemic, hemorrhagic, and undefined stroke, TIA with positive neuroimaging) and systemic embolism. Incidence rate estimated as number of participants with incident events divided by cumulative at-risk time, where participant is no longer at risk once an incident event occurred.
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Timepoint [1]
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From randomization until the efficacy cut-off date (median 326 days)
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Primary outcome [2]
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Incidence Rate of a Major Bleeding Event According to the International Society on Thrombosis and Haemostasis (ISTH) Criteria (Adjudicated)
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Assessment method [2]
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Major bleeding event (as per ISTH), defined as bleeding event that met at least one of following: fatal bleeding; symptomatic bleeding in a critical area or organ (intraarticular, intramuscular with compartment syndrome, intraocular, intraspinal, pericardial, or retroperitoneal); symptomatic intracranial haemorrhage; clinically overt bleeding associated with a recent decrease in the hemoglobin level of greater than or equal to (>=) 2 grams per decilitre (g/dL) (20 grams per liter [g/L]; 1.24 millimoles per liter [mmol/L]) compared to the most recent hemoglobin value available before the event; clinically overt bleeding leading to transfusion of 2 or more units of packed red blood cells or whole blood. The results were based on classification of events that have been positively adjudicated as major bleeding events. Incidence rate estimated as number of subjects with incident events divided by cumulative at-risk time, where subject is no longer at risk once an incident event occurred.
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Timepoint [2]
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From randomization until the efficacy cut-off date (median 326 days)
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Secondary outcome [1]
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Incidence Rate of Any of the Following: Cardiovascular Death, Recurrent Stroke, Systemic Embolism and Myocardial Infarction
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Assessment method [1]
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Incidence rate estimated as number of participants with incident events divided by cumulative at-risk time, where participant is no longer at risk once an incident event occurred. Cardiovascular death includes death due to hemorrhage and death with undetermined/unknown cause. Systemic embolism is defined as abrupt vascular insufficiency associated with clinical or radiological evidence of arterial occlusion in the absence of other likely mechanisms. The diagnosis of myocardial infarction requires the combination of: 1)evidence of myocardial necrosis (either changes in cardiac biomarkers or post-mortem pathological findings); and 2)supporting information derived from the clinical presentation, electrocardiographic changes, or the results of myocardial or coronary artery imaging.
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Timepoint [1]
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From randomization until the efficacy cut-off date (median 326 days)
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Secondary outcome [2]
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Incidence Rate of All-Cause Mortality
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Assessment method [2]
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All-cause mortality includes all deaths of participants due to any cause.
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Timepoint [2]
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From randomization until the efficacy cut-off date (median 326 days)
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Secondary outcome [3]
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Incidence Rate of the Following: Stroke, Ischemic Stroke, Disabling Stroke, Cardiovascular (CV) Death, Myocardial Infarction
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Assessment method [3]
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Disabling stroke is defined as stroke with modified Rankin score (mRS) greater than or equal to (>=) 4 as assessed by investigator. mRS spans 0-6, running from perfect health to death. A score of 0-3 indicates functional status ranging from no symptoms to "moderate disability" (defined in the mRS as requiring some help, but able to walk without assistance); mRS 4-6 indicates functional status ranging from "moderately severe disability" (unable to walk or to attend to own bodily needs without assistance)through to death. CV death includes death due to hemorrhage and death with undetermined/unknown cause. Diagnosis of myocardial infarction requires combination of: 1) evidence of myocardial necrosis either changes in cardiac biomarkers or post-mortem pathological findings); 2) supporting information derived from clinical presentation, electrocardiographic changes, or results of myocardial or coronary artery imaging.
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Timepoint [3]
0
0
From randomization until the efficacy cut-off date (median 326 days)
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Secondary outcome [4]
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Incidence Rate of Life-Threatening Bleeding Events
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Assessment method [4]
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Life-threatening bleeding was defined as a subset of major bleeding that met at least one of the following criteria: 1) fatal bleeding; 2) symptomatic intracranial haemorrhage; 3) reduction in hemoglobin of at least 5 g/dl (50 g/l; 3.10 mmol/L); 4) transfusion of at least 4 units of packed red cells or whole blood; 5) associated with hypotension requiring the use of intravenous inotropic agents; 6) necessitated surgical intervention. Incidence rate estimated as number of participants with incident events divided by cumulative at-risk time, where participant is no longer at risk once an incident event occurred.
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Timepoint [4]
0
0
From randomization until the efficacy cut-off date (median 326 days)
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Secondary outcome [5]
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Incidence Rate of Clinically Relevant Non-Major Bleeding Events
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Assessment method [5]
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Non-major clinically relevant bleeding was defined as non-major overt bleeding but required medical attention (example: hospitalization, medical treatment for bleeding), and/or was associated with the study drug interruption of more than 14 days. The results were based on the outcome events at or after randomization until the efficacy cut-off date. Incidence rate estimated as number of participants with incident events divided by cumulative at-risk time, where participant is no longer at risk once an incident event occurred.
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Timepoint [5]
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0
From randomization until the efficacy cut-off date (median 326 days)
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Secondary outcome [6]
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Incidence Rate of Intracranial Hemorrhage
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Assessment method [6]
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Intracranial hemorrhage included all bleeding events that occurred in intracerebral, sub arachnoidal as well as subdural or epidural sites. The below table displays results for all randomized participants and the outcomes at or after randomization until the efficacy cut-off date. Incidence rate estimated as number of participants with incident events divided by cumulative at-risk time, where participant is no longer at risk once an incident event occurred.
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Timepoint [6]
0
0
From randomization until the efficacy cut-off date (median 326 days)
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Eligibility
Key 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)
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Minimum age
50
Years
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Maximum age
No limit
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Sex
Both males and females
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Can healthy volunteers participate?
No
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Key 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
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Study design
Purpose of the study
Prevention
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Allocation to intervention
Randomised controlled trial
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Procedure for enrolling a subject and allocating the treatment (allocation concealment procedures)
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Methods used to generate the sequence in which subjects will be randomised (sequence generation)
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Masking / blinding
Blinded (masking used)
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Who is / are masked / blinded?
The people receiving the treatment/s
The people administering the treatment/s
The people assessing the outcomes
The people analysing the results/data
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Intervention assignment
Parallel
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Other design features
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Phase
Phase 3
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Type of endpoint/s
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Statistical methods / analysis
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Recruitment
Recruitment status
Terminated
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Data analysis
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Reason for early stopping/withdrawal
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Other reasons
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Date of first participant enrolment
Anticipated
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Actual
23/12/2014
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Date of last participant enrolment
Anticipated
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Actual
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Date of last data collection
Anticipated
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Actual
15/02/2018
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Sample size
Target
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Accrual to date
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Final
7213
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Recruitment in Australia
Recruitment state(s)
NSW,QLD,TAS,VIC,WA
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Recruitment hospital [1]
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- Camperdown
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- Waratah
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- Brisbane
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Recruitment hospital [4]
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- Southport
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Recruitment hospital [5]
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- Launceston
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Recruitment hospital [6]
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- Clayton
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Recruitment hospital [7]
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- Footscray
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Recruitment hospital [8]
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- Murdoch
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Recruitment hospital [9]
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- Elizabeth Vale
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Recruitment hospital [10]
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- Nedlands
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Recruitment postcode(s) [1]
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2050 - Camperdown
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Recruitment postcode(s) [2]
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2298 - Waratah
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Recruitment postcode(s) [3]
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4029 - Brisbane
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Recruitment postcode(s) [4]
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4215 - Southport
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Recruitment postcode(s) [5]
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7250 - Launceston
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Recruitment postcode(s) [6]
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3168 - Clayton
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Recruitment postcode(s) [7]
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3011 - Footscray
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Recruitment postcode(s) [8]
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6150 - Murdoch
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Recruitment postcode(s) [9]
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5112 - Elizabeth Vale
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Recruitment postcode(s) [10]
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6009 - Nedlands
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Recruitment outside Australia
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United States of America
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California
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Connecticut
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Florida
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Illinois
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Iowa
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Kentucky
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Louisiana
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Maryland
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Massachusetts
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Michigan
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Helsinki
Query!
Country [99]
0
0
Finland
Query!
State/province [99]
0
0
Lappeenranta
Query!
Country [100]
0
0
Finland
Query!
State/province [100]
0
0
OYS
Query!
Country [101]
0
0
Finland
Query!
State/province [101]
0
0
Sairaalamäki
Query!
Country [102]
0
0
Finland
Query!
State/province [102]
0
0
Tampere
Query!
Country [103]
0
0
Finland
Query!
State/province [103]
0
0
Turku
Query!
Country [104]
0
0
Finland
Query!
State/province [104]
0
0
Vaasa
Query!
Country [105]
0
0
France
Query!
State/province [105]
0
0
Antony Cedex
Query!
Country [106]
0
0
France
Query!
State/province [106]
0
0
Bordeaux
Query!
Country [107]
0
0
France
Query!
State/province [107]
0
0
Brest Cedex
Query!
Country [108]
0
0
France
Query!
State/province [108]
0
0
Caen Cedex
Query!
Country [109]
0
0
France
Query!
State/province [109]
0
0
Dijon
Query!
Country [110]
0
0
France
Query!
State/province [110]
0
0
Le Chesnay
Query!
Country [111]
0
0
France
Query!
State/province [111]
0
0
Limoges
Query!
Country [112]
0
0
France
Query!
State/province [112]
0
0
Nantes
Query!
Country [113]
0
0
France
Query!
State/province [113]
0
0
NIMES cedex 9
Query!
Country [114]
0
0
France
Query!
State/province [114]
0
0
PARIS cedex 14
Query!
Country [115]
0
0
France
Query!
State/province [115]
0
0
Paris
Query!
Country [116]
0
0
France
Query!
State/province [116]
0
0
Saint Priest En Jarez
Query!
Country [117]
0
0
France
Query!
State/province [117]
0
0
Strasbourg
Query!
Country [118]
0
0
Germany
Query!
State/province [118]
0
0
Baden-Württemberg
Query!
Country [119]
0
0
Germany
Query!
State/province [119]
0
0
Bayern
Query!
Country [120]
0
0
Germany
Query!
State/province [120]
0
0
Niedersachsen
Query!
Country [121]
0
0
Germany
Query!
State/province [121]
0
0
Nordrhein-Westfalen
Query!
Country [122]
0
0
Germany
Query!
State/province [122]
0
0
Sachsen-Anhalt
Query!
Country [123]
0
0
Germany
Query!
State/province [123]
0
0
Sachsen
Query!
Country [124]
0
0
Germany
Query!
State/province [124]
0
0
Thüringen
Query!
Country [125]
0
0
Germany
Query!
State/province [125]
0
0
Berlin
Query!
Country [126]
0
0
Germany
Query!
State/province [126]
0
0
Hamburg
Query!
Country [127]
0
0
Greece
Query!
State/province [127]
0
0
Athens
Query!
Country [128]
0
0
Greece
Query!
State/province [128]
0
0
Ioannina
Query!
Country [129]
0
0
Greece
Query!
State/province [129]
0
0
Larissa
Query!
Country [130]
0
0
Greece
Query!
State/province [130]
0
0
Thessaloniki
Query!
Country [131]
0
0
Hungary
Query!
State/province [131]
0
0
Budapest
Query!
Country [132]
0
0
Hungary
Query!
State/province [132]
0
0
Debrecen
Query!
Country [133]
0
0
Hungary
Query!
State/province [133]
0
0
Eger
Query!
Country [134]
0
0
Hungary
Query!
State/province [134]
0
0
Gyor
Query!
Country [135]
0
0
Hungary
Query!
State/province [135]
0
0
Kistarcsa
Query!
Country [136]
0
0
Hungary
Query!
State/province [136]
0
0
Miskolc
Query!
Country [137]
0
0
Hungary
Query!
State/province [137]
0
0
Nagykanizsa
Query!
Country [138]
0
0
Hungary
Query!
State/province [138]
0
0
Nyiregyhaza
Query!
Country [139]
0
0
Hungary
Query!
State/province [139]
0
0
Sopron
Query!
Country [140]
0
0
Hungary
Query!
State/province [140]
0
0
Szeged
Query!
Country [141]
0
0
Hungary
Query!
State/province [141]
0
0
Zalaegerszeg
Query!
Country [142]
0
0
Ireland
Query!
State/province [142]
0
0
Dublin
Query!
Country [143]
0
0
Ireland
Query!
State/province [143]
0
0
Galway
Query!
Country [144]
0
0
Israel
Query!
State/province [144]
0
0
Ashkelon
Query!
Country [145]
0
0
Israel
Query!
State/province [145]
0
0
Beer Sheva
Query!
Country [146]
0
0
Israel
Query!
State/province [146]
0
0
Haifa
Query!
Country [147]
0
0
Israel
Query!
State/province [147]
0
0
Jerusalem
Query!
Country [148]
0
0
Israel
Query!
State/province [148]
0
0
Petah Tikva
Query!
Country [149]
0
0
Israel
Query!
State/province [149]
0
0
Ramat Gan
Query!
Country [150]
0
0
Israel
Query!
State/province [150]
0
0
Tel Aviv
Query!
Country [151]
0
0
Italy
Query!
State/province [151]
0
0
Abruzzo
Query!
Country [152]
0
0
Italy
Query!
State/province [152]
0
0
Calabria
Query!
Country [153]
0
0
Italy
Query!
State/province [153]
0
0
Emilia-Romagna
Query!
Country [154]
0
0
Italy
Query!
State/province [154]
0
0
Friuli-Venezia Giulia
Query!
Country [155]
0
0
Italy
Query!
State/province [155]
0
0
Lazio
Query!
Country [156]
0
0
Italy
Query!
State/province [156]
0
0
Lombardia
Query!
Country [157]
0
0
Italy
Query!
State/province [157]
0
0
Marche
Query!
Country [158]
0
0
Italy
Query!
State/province [158]
0
0
Molise
Query!
Country [159]
0
0
Italy
Query!
State/province [159]
0
0
Sardegna
Query!
Country [160]
0
0
Italy
Query!
State/province [160]
0
0
Umbria
Query!
Country [161]
0
0
Italy
Query!
State/province [161]
0
0
Veneto
Query!
Country [162]
0
0
Japan
Query!
State/province [162]
0
0
Aichi
Query!
Country [163]
0
0
Japan
Query!
State/province [163]
0
0
Fukuoka
Query!
Country [164]
0
0
Japan
Query!
State/province [164]
0
0
Fukushima
Query!
Country [165]
0
0
Japan
Query!
State/province [165]
0
0
Hiroshima
Query!
Country [166]
0
0
Japan
Query!
State/province [166]
0
0
Hokkaido
Query!
Country [167]
0
0
Japan
Query!
State/province [167]
0
0
Hyogo
Query!
Country [168]
0
0
Japan
Query!
State/province [168]
0
0
Kanagawa
Query!
Country [169]
0
0
Japan
Query!
State/province [169]
0
0
Miyagi
Query!
Country [170]
0
0
Japan
Query!
State/province [170]
0
0
Nagasaki
Query!
Country [171]
0
0
Japan
Query!
State/province [171]
0
0
Nara
Query!
Country [172]
0
0
Japan
Query!
State/province [172]
0
0
Okayama
Query!
Country [173]
0
0
Japan
Query!
State/province [173]
0
0
Osaka
Query!
Country [174]
0
0
Japan
Query!
State/province [174]
0
0
Saitama
Query!
Country [175]
0
0
Japan
Query!
State/province [175]
0
0
Tokyo
Query!
Country [176]
0
0
Japan
Query!
State/province [176]
0
0
Kakogawa
Query!
Country [177]
0
0
Japan
Query!
State/province [177]
0
0
Kochi
Query!
Country [178]
0
0
Japan
Query!
State/province [178]
0
0
Kyoto
Query!
Country [179]
0
0
Japan
Query!
State/province [179]
0
0
Niigata
Query!
Country [180]
0
0
Korea, Republic of
Query!
State/province [180]
0
0
Gwangju Gwang''yeogsi
Query!
Country [181]
0
0
Korea, Republic of
Query!
State/province [181]
0
0
Gyeonggido
Query!
Country [182]
0
0
Korea, Republic of
Query!
State/province [182]
0
0
Seoul Teugbyeolsi
Query!
Country [183]
0
0
Korea, Republic of
Query!
State/province [183]
0
0
Busan
Query!
Country [184]
0
0
Korea, Republic of
Query!
State/province [184]
0
0
Daegu
Query!
Country [185]
0
0
Korea, Republic of
Query!
State/province [185]
0
0
Incheon
Query!
Country [186]
0
0
Korea, Republic of
Query!
State/province [186]
0
0
Seoul,
Query!
Country [187]
0
0
Korea, Republic of
Query!
State/province [187]
0
0
Seoul
Query!
Country [188]
0
0
Mexico
Query!
State/province [188]
0
0
Distrito Federal
Query!
Country [189]
0
0
Mexico
Query!
State/province [189]
0
0
Michoacán
Query!
Country [190]
0
0
Mexico
Query!
State/province [190]
0
0
México
Query!
Country [191]
0
0
Mexico
Query!
State/province [191]
0
0
Nuevo Leon
Query!
Country [192]
0
0
Mexico
Query!
State/province [192]
0
0
Yucatán
Query!
Country [193]
0
0
Mexico
Query!
State/province [193]
0
0
Aguascalientes
Query!
Country [194]
0
0
Mexico
Query!
State/province [194]
0
0
México D.F.
Query!
Country [195]
0
0
Poland
Query!
State/province [195]
0
0
Bialystok
Query!
Country [196]
0
0
Poland
Query!
State/province [196]
0
0
Chelm
Query!
Country [197]
0
0
Poland
Query!
State/province [197]
0
0
Gdansk
Query!
Country [198]
0
0
Poland
Query!
State/province [198]
0
0
Katowice
Query!
Country [199]
0
0
Poland
Query!
State/province [199]
0
0
Konskie
Query!
Country [200]
0
0
Poland
Query!
State/province [200]
0
0
Lodz
Query!
Country [201]
0
0
Poland
Query!
State/province [201]
0
0
Olsztyn
Query!
Country [202]
0
0
Poland
Query!
State/province [202]
0
0
Sandomierz
Query!
Country [203]
0
0
Poland
Query!
State/province [203]
0
0
Siedlce
Query!
Country [204]
0
0
Poland
Query!
State/province [204]
0
0
Skarzysko-Kamienna
Query!
Country [205]
0
0
Poland
Query!
State/province [205]
0
0
Warszawa
Query!
Country [206]
0
0
Portugal
Query!
State/province [206]
0
0
Porto
Query!
Country [207]
0
0
Portugal
Query!
State/province [207]
0
0
Almada
Query!
Country [208]
0
0
Portugal
Query!
State/province [208]
0
0
Amadora
Query!
Country [209]
0
0
Portugal
Query!
State/province [209]
0
0
Coimbra
Query!
Country [210]
0
0
Portugal
Query!
State/province [210]
0
0
Lisboa
Query!
Country [211]
0
0
Portugal
Query!
State/province [211]
0
0
Vila Franca de Xira
Query!
Country [212]
0
0
Russian Federation
Query!
State/province [212]
0
0
Chelyabinsk
Query!
Country [213]
0
0
Russian Federation
Query!
State/province [213]
0
0
Ekaterinburg
Query!
Country [214]
0
0
Russian Federation
Query!
State/province [214]
0
0
Kaluga
Query!
Country [215]
0
0
Russian Federation
Query!
State/province [215]
0
0
Kazan
Query!
Country [216]
0
0
Russian Federation
Query!
State/province [216]
0
0
Krasnoyarsk
Query!
Country [217]
0
0
Russian Federation
Query!
State/province [217]
0
0
Moscow
Query!
Country [218]
0
0
Russian Federation
Query!
State/province [218]
0
0
Nizhny Novgorod
Query!
Country [219]
0
0
Russian Federation
Query!
State/province [219]
0
0
St. Petersburg
Query!
Country [220]
0
0
Russian Federation
Query!
State/province [220]
0
0
Tomsk
Query!
Country [221]
0
0
Russian Federation
Query!
State/province [221]
0
0
Ulyanovsk
Query!
Country [222]
0
0
Russian Federation
Query!
State/province [222]
0
0
Volgograd
Query!
Country [223]
0
0
Russian Federation
Query!
State/province [223]
0
0
Yaroslavl
Query!
Country [224]
0
0
Russian Federation
Query!
State/province [224]
0
0
Yekaterinburg
Query!
Country [225]
0
0
South Africa
Query!
State/province [225]
0
0
Western Cape
Query!
Country [226]
0
0
South Africa
Query!
State/province [226]
0
0
Durban
Query!
Country [227]
0
0
Spain
Query!
State/province [227]
0
0
A Coruña
Query!
Country [228]
0
0
Spain
Query!
State/province [228]
0
0
Barcelona
Query!
Country [229]
0
0
Spain
Query!
State/province [229]
0
0
Castellón
Query!
Country [230]
0
0
Spain
Query!
State/province [230]
0
0
Murcia
Query!
Country [231]
0
0
Spain
Query!
State/province [231]
0
0
Badajoz
Query!
Country [232]
0
0
Spain
Query!
State/province [232]
0
0
Bilbao
Query!
Country [233]
0
0
Spain
Query!
State/province [233]
0
0
Cáceres
Query!
Country [234]
0
0
Spain
Query!
State/province [234]
0
0
Girona
Query!
Country [235]
0
0
Spain
Query!
State/province [235]
0
0
Granada
Query!
Country [236]
0
0
Spain
Query!
State/province [236]
0
0
León
Query!
Country [237]
0
0
Spain
Query!
State/province [237]
0
0
Lleida
Query!
Country [238]
0
0
Spain
Query!
State/province [238]
0
0
Madrid
Query!
Country [239]
0
0
Spain
Query!
State/province [239]
0
0
Sevilla
Query!
Country [240]
0
0
Spain
Query!
State/province [240]
0
0
Valencia
Query!
Country [241]
0
0
Spain
Query!
State/province [241]
0
0
Valladolid
Query!
Country [242]
0
0
Spain
Query!
State/province [242]
0
0
Zaragoza
Query!
Country [243]
0
0
Sweden
Query!
State/province [243]
0
0
Goteborg
Query!
Country [244]
0
0
Sweden
Query!
State/province [244]
0
0
Hässleholm
Query!
Country [245]
0
0
Sweden
Query!
State/province [245]
0
0
Lund
Query!
Country [246]
0
0
Sweden
Query!
State/province [246]
0
0
Malmö
Query!
Country [247]
0
0
Sweden
Query!
State/province [247]
0
0
Umeå
Query!
Country [248]
0
0
Switzerland
Query!
State/province [248]
0
0
Aargau
Query!
Country [249]
0
0
Switzerland
Query!
State/province [249]
0
0
Basel-Stadt
Query!
Country [250]
0
0
Switzerland
Query!
State/province [250]
0
0
Ticino
Query!
Country [251]
0
0
Switzerland
Query!
State/province [251]
0
0
Baden
Query!
Country [252]
0
0
Switzerland
Query!
State/province [252]
0
0
Bern
Query!
Country [253]
0
0
Switzerland
Query!
State/province [253]
0
0
Fribourg
Query!
Country [254]
0
0
Switzerland
Query!
State/province [254]
0
0
Genève
Query!
Country [255]
0
0
Switzerland
Query!
State/province [255]
0
0
Zürich
Query!
Country [256]
0
0
Turkey
Query!
State/province [256]
0
0
Ankara
Query!
Country [257]
0
0
Turkey
Query!
State/province [257]
0
0
Antakya
Query!
Country [258]
0
0
Turkey
Query!
State/province [258]
0
0
Istanbul
Query!
Country [259]
0
0
Turkey
Query!
State/province [259]
0
0
Kahramanmaras
Query!
Country [260]
0
0
Turkey
Query!
State/province [260]
0
0
Konya
Query!
Country [261]
0
0
United Kingdom
Query!
State/province [261]
0
0
Buckinghamshire
Query!
Country [262]
0
0
United Kingdom
Query!
State/province [262]
0
0
Cambridgeshire
Query!
Country [263]
0
0
United Kingdom
Query!
State/province [263]
0
0
Devon
Query!
Country [264]
0
0
United Kingdom
Query!
State/province [264]
0
0
Essex
Query!
Country [265]
0
0
United Kingdom
Query!
State/province [265]
0
0
Gloucestershire
Query!
Country [266]
0
0
United Kingdom
Query!
State/province [266]
0
0
Hertfordshire
Query!
Country [267]
0
0
United Kingdom
Query!
State/province [267]
0
0
Kent
Query!
Country [268]
0
0
United Kingdom
Query!
State/province [268]
0
0
Leicestershire
Query!
Country [269]
0
0
United Kingdom
Query!
State/province [269]
0
0
Lincolnshire
Query!
Country [270]
0
0
United Kingdom
Query!
State/province [270]
0
0
London
Query!
Country [271]
0
0
United Kingdom
Query!
State/province [271]
0
0
Norfolk
Query!
Country [272]
0
0
United Kingdom
Query!
State/province [272]
0
0
Somerset
Query!
Country [273]
0
0
United Kingdom
Query!
State/province [273]
0
0
South Yorkshire
Query!
Country [274]
0
0
United Kingdom
Query!
State/province [274]
0
0
Staffordshire
Query!
Country [275]
0
0
United Kingdom
Query!
State/province [275]
0
0
Stratchclyde
Query!
Country [276]
0
0
United Kingdom
Query!
State/province [276]
0
0
Tyne And Wear
Query!
Country [277]
0
0
United Kingdom
Query!
State/province [277]
0
0
West Midlands
Query!
Country [278]
0
0
United Kingdom
Query!
State/province [278]
0
0
West Yorkshire
Query!
Country [279]
0
0
United Kingdom
Query!
State/province [279]
0
0
Wiltshire
Query!
Country [280]
0
0
United Kingdom
Query!
State/province [280]
0
0
Aberdeen
Query!
Country [281]
0
0
United Kingdom
Query!
State/province [281]
0
0
Durham
Query!
Country [282]
0
0
United Kingdom
Query!
State/province [282]
0
0
Edinburgh
Query!
Country [283]
0
0
United Kingdom
Query!
State/province [283]
0
0
Luton
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Country [284]
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United Kingdom
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Norwich
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Funding & Sponsors
Primary sponsor type
Commercial sector/Industry
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Name
Bayer
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Address
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Other collaborator category [1]
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Commercial sector/Industry
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Name [1]
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Janssen Research & Development, LLC
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Other
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Population Health Research Institute
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Ethics approval
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Summary
Brief summary
This is a study in patients who recently had a brain attack (stroke) and in whom no clear
cause of the stroke could be identified. These strokes are likely due to a blood clot and
therefore, can be called embolic stroke of undetermined source. The abbreviation is ESUS. The
study will compare 2 blood thinners. Patients will be randomly assigned to either Rivaroxaban
15 mg or Aspirin 100 mg and the study is intended to show, if patients given rivaroxaban have
fewer blood clots in the brain (stroke) or in other blood vessels.
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Trial website
https://clinicaltrials.gov/ct2/show/NCT02313909
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Public notes
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Contacts
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Bayer Study Director
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Bayer
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Contact person for scientific queries
Summary Results
For IPD and results data, please see
https://clinicaltrials.gov/ct2/show/NCT02313909
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