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Trial details imported from ClinicalTrials.gov

For full trial details, please see the original record at https://clinicaltrials.gov/study/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)
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)
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
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
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
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
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
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
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
Sex
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
Stopped early
Data analysis
Reason for early stopping/withdrawal
Other reasons
Date of first participant enrolment
Anticipated
Actual
23/12/2014
Date of last participant enrolment
Anticipated
Actual
Date of last data collection
Anticipated
Actual
15/02/2018
Sample size
Target
Accrual to date
Final
7213
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
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4215 - Southport
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7250 - Launceston
Recruitment postcode(s) [6] 0 0
3168 - Clayton
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3011 - Footscray
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6150 - Murdoch
Recruitment postcode(s) [9] 0 0
5112 - Elizabeth Vale
Recruitment postcode(s) [10] 0 0
6009 - Nedlands
Recruitment outside Australia
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Country [213] 0 0
Russian Federation
State/province [213] 0 0
Ekaterinburg
Country [214] 0 0
Russian Federation
State/province [214] 0 0
Kaluga
Country [215] 0 0
Russian Federation
State/province [215] 0 0
Kazan
Country [216] 0 0
Russian Federation
State/province [216] 0 0
Krasnoyarsk
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Russian Federation
State/province [217] 0 0
Moscow
Country [218] 0 0
Russian Federation
State/province [218] 0 0
Nizhny Novgorod
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Russian Federation
State/province [219] 0 0
St. Petersburg
Country [220] 0 0
Russian Federation
State/province [220] 0 0
Tomsk
Country [221] 0 0
Russian Federation
State/province [221] 0 0
Ulyanovsk
Country [222] 0 0
Russian Federation
State/province [222] 0 0
Volgograd
Country [223] 0 0
Russian Federation
State/province [223] 0 0
Yaroslavl
Country [224] 0 0
Russian Federation
State/province [224] 0 0
Yekaterinburg
Country [225] 0 0
South Africa
State/province [225] 0 0
Western Cape
Country [226] 0 0
South Africa
State/province [226] 0 0
Durban
Country [227] 0 0
Spain
State/province [227] 0 0
A Coruña
Country [228] 0 0
Spain
State/province [228] 0 0
Barcelona
Country [229] 0 0
Spain
State/province [229] 0 0
Castellón
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Spain
State/province [230] 0 0
Murcia
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Spain
State/province [231] 0 0
Badajoz
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Spain
State/province [232] 0 0
Bilbao
Country [233] 0 0
Spain
State/province [233] 0 0
Cáceres
Country [234] 0 0
Spain
State/province [234] 0 0
Girona
Country [235] 0 0
Spain
State/province [235] 0 0
Granada
Country [236] 0 0
Spain
State/province [236] 0 0
León
Country [237] 0 0
Spain
State/province [237] 0 0
Lleida
Country [238] 0 0
Spain
State/province [238] 0 0
Madrid
Country [239] 0 0
Spain
State/province [239] 0 0
Sevilla
Country [240] 0 0
Spain
State/province [240] 0 0
Valencia
Country [241] 0 0
Spain
State/province [241] 0 0
Valladolid
Country [242] 0 0
Spain
State/province [242] 0 0
Zaragoza
Country [243] 0 0
Sweden
State/province [243] 0 0
Goteborg
Country [244] 0 0
Sweden
State/province [244] 0 0
Hässleholm
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Sweden
State/province [245] 0 0
Lund
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Sweden
State/province [246] 0 0
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Sweden
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Umeå
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Switzerland
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Aargau
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Switzerland
State/province [249] 0 0
Basel-Stadt
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Switzerland
State/province [250] 0 0
Ticino
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Switzerland
State/province [251] 0 0
Baden
Country [252] 0 0
Switzerland
State/province [252] 0 0
Bern
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Switzerland
State/province [253] 0 0
Fribourg
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Switzerland
State/province [254] 0 0
Genève
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Switzerland
State/province [255] 0 0
Zürich
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Turkey
State/province [256] 0 0
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Turkey
State/province [257] 0 0
Antakya
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Turkey
State/province [258] 0 0
Istanbul
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Turkey
State/province [259] 0 0
Kahramanmaras
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Turkey
State/province [260] 0 0
Konya
Country [261] 0 0
United Kingdom
State/province [261] 0 0
Buckinghamshire
Country [262] 0 0
United Kingdom
State/province [262] 0 0
Cambridgeshire
Country [263] 0 0
United Kingdom
State/province [263] 0 0
Devon
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United Kingdom
State/province [264] 0 0
Essex
Country [265] 0 0
United Kingdom
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Gloucestershire
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United Kingdom
State/province [266] 0 0
Hertfordshire
Country [267] 0 0
United Kingdom
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Kent
Country [268] 0 0
United Kingdom
State/province [268] 0 0
Leicestershire
Country [269] 0 0
United Kingdom
State/province [269] 0 0
Lincolnshire
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United Kingdom
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London
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United Kingdom
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Norfolk
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United Kingdom
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Somerset
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United Kingdom
State/province [273] 0 0
South Yorkshire
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United Kingdom
State/province [274] 0 0
Staffordshire
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United Kingdom
State/province [275] 0 0
Stratchclyde
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United Kingdom
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Tyne And Wear
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United Kingdom
State/province [277] 0 0
West Midlands
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United Kingdom
State/province [278] 0 0
West Yorkshire
Country [279] 0 0
United Kingdom
State/province [279] 0 0
Wiltshire
Country [280] 0 0
United Kingdom
State/province [280] 0 0
Aberdeen
Country [281] 0 0
United Kingdom
State/province [281] 0 0
Durham
Country [282] 0 0
United Kingdom
State/province [282] 0 0
Edinburgh
Country [283] 0 0
United Kingdom
State/province [283] 0 0
Luton
Country [284] 0 0
United Kingdom
State/province [284] 0 0
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
Trial website
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

No information has been provided regarding IPD availability


What supporting documents are/will be available?




Results publications and other study-related documents


Results are available at https://clinicaltrials.gov/study/NCT02313909