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Trial details imported from ClinicalTrials.gov

For full trial details, please see the original record at https://clinicaltrials.gov/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)
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
Secondary ID [1] 0 0
2013-000768-27
Secondary ID [2] 0 0
16573
Universal Trial Number (UTN)
Trial acronym
NAVIGATE ESUS
Linked study record

Health condition
Health condition(s) or problem(s) studied:
Stroke 0 0
Condition category
Condition code
Stroke 0 0 0 0
Haemorrhagic
Stroke 0 0 0 0
Ischaemic
Cardiovascular 0 0 0 0
Diseases of the vasculature and circulation including the lymphatic system
Blood 0 0 0 0
Clotting disorders

Intervention/exposure
Study type
Interventional
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

Intervention code [1] 0 0
Treatment: Drugs
Intervention code [2] 0 0
Other interventions
Comparator / control treatment
Control group

Outcomes
Primary outcome [1] 0 0
Incidence Rate of the Composite Efficacy Outcome (Adjudicated) - 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.
Timepoint [1] 0 0
From randomization until the efficacy cut-off date (median 326 days)
Primary outcome [2] 0 0
Incidence Rate of a Major Bleeding Event According to the International Society on Thrombosis and Haemostasis (ISTH) Criteria (Adjudicated) - 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.
Timepoint [2] 0 0
From randomization until the efficacy cut-off date (median 326 days)
Secondary outcome [1] 0 0
Incidence Rate of Any of the Following: Cardiovascular Death, Recurrent Stroke, Systemic Embolism and Myocardial Infarction - 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.
Timepoint [1] 0 0
From randomization until the efficacy cut-off date (median 326 days)
Secondary outcome [2] 0 0
Incidence Rate of All-Cause Mortality - All-cause mortality includes all deaths of participants due to any cause.
Timepoint [2] 0 0
From randomization until the efficacy cut-off date (median 326 days)
Secondary outcome [3] 0 0
Incidence Rate of the Following: Stroke, Ischemic Stroke, Disabling Stroke, Cardiovascular (CV) Death, Myocardial Infarction - 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.
Timepoint [3] 0 0
From randomization until the efficacy cut-off date (median 326 days)
Secondary outcome [4] 0 0
Incidence Rate of Life-Threatening Bleeding Events - 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.
Timepoint [4] 0 0
From randomization until the efficacy cut-off date (median 326 days)
Secondary outcome [5] 0 0
Incidence Rate of Clinically Relevant Non-Major Bleeding Events - 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.
Timepoint [5] 0 0
From randomization until the efficacy cut-off date (median 326 days)
Secondary outcome [6] 0 0
Incidence Rate of Intracranial Hemorrhage - 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.
Timepoint [6] 0 0
From randomization until the efficacy cut-off date (median 326 days)

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)
Minimum age
50 Years
Maximum age
No limit
Gender
Both males and females
Can healthy volunteers participate?
No
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

Study design
Purpose of the study
Prevention
Allocation to intervention
Randomised controlled trial
Procedure for enrolling a subject and allocating the treatment (allocation concealment procedures)
Methods used to generate the sequence in which subjects will be randomised (sequence generation)
Masking / blinding
Blinded (masking used)
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
Intervention assignment
Parallel
Other design features
Phase
Phase 3
Type of endpoint(s)
Statistical methods / analysis

Recruitment
Recruitment status
Terminated
Data analysis
Reason for early stopping/withdrawal
Other reasons
Date of first participant enrolment
Anticipated
Actual
Date of last participant enrolment
Anticipated
Actual
Date of last data collection
Anticipated
Actual
Sample size
Target
Accrual to date
Final
Recruitment in Australia
Recruitment state(s)
NSW,QLD,TAS,VIC,WA
Recruitment hospital [1] 0 0
- Camperdown
Recruitment hospital [2] 0 0
- Waratah
Recruitment hospital [3] 0 0
- Brisbane
Recruitment hospital [4] 0 0
- Southport
Recruitment hospital [5] 0 0
- Launceston
Recruitment hospital [6] 0 0
- Clayton
Recruitment hospital [7] 0 0
- Footscray
Recruitment hospital [8] 0 0
- Murdoch
Recruitment hospital [9] 0 0
- Elizabeth Vale
Recruitment hospital [10] 0 0
- Nedlands
Recruitment postcode(s) [1] 0 0
2050 - Camperdown
Recruitment postcode(s) [2] 0 0
2298 - Waratah
Recruitment postcode(s) [3] 0 0
4029 - Brisbane
Recruitment postcode(s) [4] 0 0
4215 - Southport
Recruitment postcode(s) [5] 0 0
7250 - Launceston
Recruitment postcode(s) [6] 0 0
3168 - Clayton
Recruitment postcode(s) [7] 0 0
3011 - Footscray
Recruitment postcode(s) [8] 0 0
6150 - Murdoch
Recruitment postcode(s) [9] 0 0
5112 - Elizabeth Vale
Recruitment postcode(s) [10] 0 0
6009 - Nedlands
Recruitment outside Australia
Country [1] 0 0
United States of America
State/province [1] 0 0
Arizona
Country [2] 0 0
United States of America
State/province [2] 0 0
California
Country [3] 0 0
United States of America
State/province [3] 0 0
Connecticut
Country [4] 0 0
United States of America
State/province [4] 0 0
Florida
Country [5] 0 0
United States of America
State/province [5] 0 0
Illinois
Country [6] 0 0
United States of America
State/province [6] 0 0
Iowa
Country [7] 0 0
United States of America
State/province [7] 0 0
Kentucky
Country [8] 0 0
United States of America
State/province [8] 0 0
Louisiana
Country [9] 0 0
United States of America
State/province [9] 0 0
Maryland
Country [10] 0 0
United States of America
State/province [10] 0 0
Massachusetts
Country [11] 0 0
United States of America
State/province [11] 0 0
Michigan
Country [12] 0 0
United States of America
State/province [12] 0 0
New Jersey
Country [13] 0 0
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New York
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State/province [14] 0 0
Ohio
Country [15] 0 0
United States of America
State/province [15] 0 0
Oregon
Country [16] 0 0
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State/province [16] 0 0
Pennsylvania
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United States of America
State/province [17] 0 0
South Carolina
Country [18] 0 0
United States of America
State/province [18] 0 0
Tennessee
Country [19] 0 0
United States of America
State/province [19] 0 0
Texas
Country [20] 0 0
United States of America
State/province [20] 0 0
Utah
Country [21] 0 0
United States of America
State/province [21] 0 0
Washington
Country [22] 0 0
Argentina
State/province [22] 0 0
Buenos Aires
Country [23] 0 0
Argentina
State/province [23] 0 0
Ciudad Auton. De Buenos Aires
Country [24] 0 0
Argentina
State/province [24] 0 0
Santa Fe
Country [25] 0 0
Argentina
State/province [25] 0 0
Ciudad Auton. de Buenos Aires
Country [26] 0 0
Argentina
State/province [26] 0 0
Córdoba
Country [27] 0 0
Austria
State/province [27] 0 0
Kärnten
Country [28] 0 0
Austria
State/province [28] 0 0
Niederösterreich
Country [29] 0 0
Austria
State/province [29] 0 0
Oberösterreich
Country [30] 0 0
Austria
State/province [30] 0 0
Steiermark
Country [31] 0 0
Austria
State/province [31] 0 0
Vorarlberg
Country [32] 0 0
Austria
State/province [32] 0 0
Salzburg
Country [33] 0 0
Austria
State/province [33] 0 0
Wien
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Belgium
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West-Vlaanderen
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Belgium
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Antwerpen
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Belgium
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Brussel
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Belgium
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Bruxelles - Brussel
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Belgium
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Dendermonde
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Belgium
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Edegem
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Belgium
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Hasselt
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Bahia
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Rio Grande Do Sul
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Santa Catarina
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Brazil
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Sao Paulo
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Brazil
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Rio de Janeiro
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Alberta
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British Columbia
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Manitoba
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New Brunswick
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Nova Scotia
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Ontario
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Chile
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Bío-Bío
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Los Lagos
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Valparaíso
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Santiago
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Chile
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Viña del Mar
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China
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Fujian
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Gansu
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Hainan
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Hebei
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China
State/province [64] 0 0
Heilongjiang
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China
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Henan
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China
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Hubei
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Hunan
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Inner Mongolia
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China
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Jiangsu
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China
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Jiangxi
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China
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Jilin
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China
State/province [72] 0 0
Liaoning
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China
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Shandong
Country [74] 0 0
China
State/province [74] 0 0
Shanxi
Country [75] 0 0
China
State/province [75] 0 0
Yunnan
Country [76] 0 0
China
State/province [76] 0 0
Zhejiang
Country [77] 0 0
China
State/province [77] 0 0
Beijing
Country [78] 0 0
China
State/province [78] 0 0
Chongqing
Country [79] 0 0
China
State/province [79] 0 0
Guangzhou
Country [80] 0 0
China
State/province [80] 0 0
Shanghai
Country [81] 0 0
China
State/province [81] 0 0
Tianjin
Country [82] 0 0
Czechia
State/province [82] 0 0
Blansko
Country [83] 0 0
Czechia
State/province [83] 0 0
Brno
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Czechia
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Hradec Kralove
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Czechia
State/province [85] 0 0
Jihlava
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Czechia
State/province [86] 0 0
Olomouc
Country [87] 0 0
Czechia
State/province [87] 0 0
Ostrava Vitkovice
Country [88] 0 0
Czechia
State/province [88] 0 0
Ostrava-Poruba
Country [89] 0 0
Czechia
State/province [89] 0 0
Praha 2
Country [90] 0 0
Czechia
State/province [90] 0 0
Praha 3
Country [91] 0 0
Czechia
State/province [91] 0 0
Vyskov
Country [92] 0 0
Denmark
State/province [92] 0 0
Aalborg
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Denmark
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Aarhus C
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Denmark
State/province [94] 0 0
Copenhagen
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Denmark
State/province [95] 0 0
Glostrup
Country [96] 0 0
Denmark
State/province [96] 0 0
Herlev
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Denmark
State/province [97] 0 0
Hillerød
Country [98] 0 0
Finland
State/province [98] 0 0
Helsinki
Country [99] 0 0
Finland
State/province [99] 0 0
Lappeenranta
Country [100] 0 0
Finland
State/province [100] 0 0
OYS
Country [101] 0 0
Finland
State/province [101] 0 0
Sairaalamäki
Country [102] 0 0
Finland
State/province [102] 0 0
Tampere
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Finland
State/province [103] 0 0
Turku
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Finland
State/province [104] 0 0
Vaasa
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France
State/province [105] 0 0
Antony Cedex
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France
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Bordeaux
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France
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Brest Cedex
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France
State/province [108] 0 0
Caen Cedex
Country [109] 0 0
France
State/province [109] 0 0
Dijon
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France
State/province [110] 0 0
Le Chesnay
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France
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Limoges
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France
State/province [112] 0 0
Nantes
Country [113] 0 0
France
State/province [113] 0 0
NIMES cedex 9
Country [114] 0 0
France
State/province [114] 0 0
PARIS cedex 14
Country [115] 0 0
France
State/province [115] 0 0
Paris
Country [116] 0 0
France
State/province [116] 0 0
Saint Priest En Jarez
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France
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Strasbourg
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Germany
State/province [118] 0 0
Baden-Württemberg
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Germany
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Bayern
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Germany
State/province [120] 0 0
Niedersachsen
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Germany
State/province [121] 0 0
Nordrhein-Westfalen
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Germany
State/province [122] 0 0
Sachsen-Anhalt
Country [123] 0 0
Germany
State/province [123] 0 0
Sachsen
Country [124] 0 0
Germany
State/province [124] 0 0
Thüringen
Country [125] 0 0
Germany
State/province [125] 0 0
Berlin
Country [126] 0 0
Germany
State/province [126] 0 0
Hamburg
Country [127] 0 0
Greece
State/province [127] 0 0
Athens
Country [128] 0 0
Greece
State/province [128] 0 0
Ioannina
Country [129] 0 0
Greece
State/province [129] 0 0
Larissa
Country [130] 0 0
Greece
State/province [130] 0 0
Thessaloniki
Country [131] 0 0
Hungary
State/province [131] 0 0
Budapest
Country [132] 0 0
Hungary
State/province [132] 0 0
Debrecen
Country [133] 0 0
Hungary
State/province [133] 0 0
Eger
Country [134] 0 0
Hungary
State/province [134] 0 0
Gyor
Country [135] 0 0
Hungary
State/province [135] 0 0
Kistarcsa
Country [136] 0 0
Hungary
State/province [136] 0 0
Miskolc
Country [137] 0 0
Hungary
State/province [137] 0 0
Nagykanizsa
Country [138] 0 0
Hungary
State/province [138] 0 0
Nyiregyhaza
Country [139] 0 0
Hungary
State/province [139] 0 0
Sopron
Country [140] 0 0
Hungary
State/province [140] 0 0
Szeged
Country [141] 0 0
Hungary
State/province [141] 0 0
Zalaegerszeg
Country [142] 0 0
Ireland
State/province [142] 0 0
Dublin
Country [143] 0 0
Ireland
State/province [143] 0 0
Galway
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Israel
State/province [144] 0 0
Ashkelon
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Israel
State/province [145] 0 0
Beer Sheva
Country [146] 0 0
Israel
State/province [146] 0 0
Haifa
Country [147] 0 0
Israel
State/province [147] 0 0
Jerusalem
Country [148] 0 0
Israel
State/province [148] 0 0
Petah Tikva
Country [149] 0 0
Israel
State/province [149] 0 0
Ramat Gan
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Israel
State/province [150] 0 0
Tel Aviv
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Italy
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Abruzzo
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Italy
State/province [152] 0 0
Calabria
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Italy
State/province [153] 0 0
Emilia-Romagna
Country [154] 0 0
Italy
State/province [154] 0 0
Friuli-Venezia Giulia
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Italy
State/province [155] 0 0
Lazio
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Italy
State/province [156] 0 0
Lombardia
Country [157] 0 0
Italy
State/province [157] 0 0
Marche
Country [158] 0 0
Italy
State/province [158] 0 0
Molise
Country [159] 0 0
Italy
State/province [159] 0 0
Sardegna
Country [160] 0 0
Italy
State/province [160] 0 0
Umbria
Country [161] 0 0
Italy
State/province [161] 0 0
Veneto
Country [162] 0 0
Japan
State/province [162] 0 0
Aichi
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Japan
State/province [163] 0 0
Fukuoka
Country [164] 0 0
Japan
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Fukushima
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Japan
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Hiroshima
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Japan
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Hokkaido
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Japan
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Hyogo
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Japan
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Kanagawa
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Japan
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Miyagi
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Japan
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Nagasaki
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Japan
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Nara
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Japan
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Okayama
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Japan
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Osaka
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Japan
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Saitama
Country [175] 0 0
Japan
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Tokyo
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Japan
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Kakogawa
Country [177] 0 0
Japan
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Kochi
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Japan
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Kyoto
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Japan
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Niigata
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Korea, Republic of
State/province [180] 0 0
Gwangju Gwang''yeogsi
Country [181] 0 0
Korea, Republic of
State/province [181] 0 0
Gyeonggido
Country [182] 0 0
Korea, Republic of
State/province [182] 0 0
Seoul Teugbyeolsi
Country [183] 0 0
Korea, Republic of
State/province [183] 0 0
Busan
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Norwich

Funding & Sponsors
Primary sponsor type
Commercial sector/Industry
Name
Bayer
Address
Country
Other collaborator category [1] 0 0
Commercial sector/Industry
Name [1] 0 0
Janssen Research & Development, LLC
Address [1] 0 0
Country [1] 0 0
Other collaborator category [2] 0 0
Other
Name [2] 0 0
Population Health Research Institute
Address [2] 0 0
Country [2] 0 0

Ethics approval
Ethics application status

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.
Trial website
https://clinicaltrials.gov/show/NCT02313909
Trial related presentations / publications
Public notes

Contacts
Principal investigator
Name 0 0
Bayer Study Director
Address 0 0
Bayer
Country 0 0
Phone 0 0
Fax 0 0
Email 0 0
Contact person for public queries
Name 0 0
Address 0 0
Country 0 0
Phone 0 0
Fax 0 0
Email 0 0
Contact person for scientific queries

Summary results
For IPD and results data, please see https://clinicaltrials.gov/show/NCT02313909