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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/NCT00412984




Registration number
NCT00412984
Ethics application status
Date submitted
18/12/2006
Date registered
19/12/2006
Date last updated
3/07/2018

Titles & IDs
Public title
Apixaban for the Prevention of Stroke in Subjects With Atrial Fibrillation
Scientific title
A Phase 3, Active (Warfarin) Controlled, Randomized, Double-Blind, Parallel Arm Study to Evaluate Efficacy and Safety of Apixaban in Preventing Stroke and Systemic Embolism in Subjects With Nonvalvular Atrial Fibrillation
Secondary ID [1] 0 0
CV185-030
Universal Trial Number (UTN)
Trial acronym
ARISTOTLE
Linked study record

Health condition
Health condition(s) or problem(s) studied:
Atrial Fibrillation 0 0
Atrial Flutter 0 0
Condition category
Condition code
Cardiovascular 0 0 0 0
Other cardiovascular diseases
Cardiovascular 0 0 0 0
Coronary heart disease

Intervention/exposure
Study type
Interventional
Description of intervention(s) / exposure
Treatment: Drugs - warfarin
Treatment: Drugs - apixaban

Active Comparator: 1 -

Experimental: 2 -


Treatment: Drugs: warfarin
Oral tablets, 2.0 mg, adjusted to an INR of 2.5 (range 2.0 to 3.0)

Treatment: Drugs: apixaban
Oral tablets, 5.0 mg or 2.5 mg, twice daily
Intervention code [1] 0 0
Treatment: Drugs
Comparator / control treatment
Control group

Outcomes
Primary outcome [1] 0 0
Number of Participants With First Event of Ischemic/Unspecified Stroke, Hemorrhagic Stroke, or Systemic Embolism (SE) During the Intended Treatment Period
Timepoint [1] 0 0
Time to first event in "Intended Treatment Period": started on day of randomization, ended at efficacy cut-off date (date target number of primary efficacy events [448] was expected to have occurred; set to 30-Jan-2011, prior to unblinding).
Primary outcome [2] 0 0
Rate of Adjudicated Stroke or Systemic Embolism (SE) During the Intended Treatment Period
Timepoint [2] 0 0
"Intended Treatment Period" started on the day of randomization and ended at the efficacy cut-off date (date on which it was expected that the target number of primary efficacy events [448] would have occurred; set to 30-Jan-2011, prior to unblinding).
Secondary outcome [1] 0 0
Number of Participants With Event of Major (International Society on Thrombosis and Hemostasis [ISTH]) Bleeding During Treatment Period
Timepoint [1] 0 0
"Treatment Period" started with first dose of blinded study drug and ended 2 days after the last dose of blinded study drug. Mean duration of exposure to double-blind study drug was 1.7 years in each treatment group.
Secondary outcome [2] 0 0
Rate of Adjudicated Major (ISTH) Bleed Events During Treatment Period
Timepoint [2] 0 0
"Treatment Period" started with first dose of blinded study drug and ended 2 days after the last dose of blinded study drug. Mean duration of exposure to double-blind study drug was 1.7 years in each treatment group.
Secondary outcome [3] 0 0
Number of Participants With Events of All-Cause Death During the Intended Treatment Period
Timepoint [3] 0 0
"Intended Treatment Period" started on the day of randomization and ended at the efficacy cut-off date (date on which it was expected that the target number of primary efficacy events [448] would have occurred; set to 30-Jan-2011, prior to unblinding).
Secondary outcome [4] 0 0
Rate of Adjudicated All-Cause Death During the Intended Treatment Period
Timepoint [4] 0 0
"Intended Treatment Period" started on the day of randomization and ended at the efficacy cut-off date (date on which it was expected that the target number of primary efficacy events [448] would have occurred; set to 30-Jan-2011, prior to unblinding).
Secondary outcome [5] 0 0
Rate of Ischemic or Unspecified Stroke, Hemorrhagic Stroke, Systemic Embolism (SE), and Myocardial Infarction (MI) (as Individual Endpoints) During the Intended Treatment Period
Timepoint [5] 0 0
"Intended Treatment Period" started on the day of randomization and ended at the efficacy cut-off date (date on which it was expected that the target number of primary efficacy events [448] would have occurred; set to 30-Jan-2011, prior to unblinding).
Secondary outcome [6] 0 0
Rate of Ischemic or Unspecified Stroke, Hemorrhagic Stroke, Systemic Embolism (SE), Myocardial Infarction (MI) and All-Cause Death (ACD) (as Composite Endpoints) During the Intended Treatment Period
Timepoint [6] 0 0
"Intended Treatment Period" started on the day of randomization and ended at the efficacy cut-off date (date on which it was expected that the target number of primary efficacy events [448] would have occurred; set to 30-Jan-2011, prior to unblinding).
Secondary outcome [7] 0 0
Number of Warfarin/Vitamin K Antagonist (VKA) Naive Participants With Composite Stroke / Systemic Embolism (SE) / Major Bleeding During the Intended Treatment Period
Timepoint [7] 0 0
"Intended Treatment Period" started on the day of randomization and ended at the efficacy cut-off date (date on which it was expected that the target number of primary efficacy events [448] would have occurred; set to 30-Jan-2011, prior to unblinding).
Secondary outcome [8] 0 0
Rate of Composite Stroke / Systemic Embolism / Major Bleeding in Warfarin/Vitamin K Antagonist (VKA) Naive Participants During the Intended Treatment Period
Timepoint [8] 0 0
"Intended Treatment Period" started on the day of randomization and ended at the efficacy cut-off date (date on which it was expected that the target number of primary efficacy events [448] would have occurred; set to 30-Jan-2011, prior to unblinding).
Secondary outcome [9] 0 0
Number of Participants With Events of Major or Clinically Relevant Nonmajor (CRNM) Bleed During Treatment Period
Timepoint [9] 0 0
"Treatment Period" started with first dose of blinded study drug and ended 2 days after the last dose of blinded study drug. Mean duration of exposure to double-blind study drug was 1.7 years in each treatment group.
Secondary outcome [10] 0 0
Rate of Events of Major or Clinically Relevant Non-Major (CRNM) Bleed During Treatment Period
Timepoint [10] 0 0
"Treatment Period" started with first dose of blinded study drug and ended 2 days after the last dose of blinded study drug. Mean duration of exposure to double-blind study drug was 1.7 years in each treatment group.
Secondary outcome [11] 0 0
Number of Participants With All Bleeding Events During Treatment Period
Timepoint [11] 0 0
"Treatment Period" started with first dose of blinded study drug and ended 2 days after the last dose of blinded study drug. Mean duration of exposure to double-blind study drug was 1.7 years in each treatment group.
Secondary outcome [12] 0 0
Rate of All Bleeding Events During Treatment Period
Timepoint [12] 0 0
"Treatment Period" started with first dose of blinded study drug and ended 2 days after the last dose of blinded study drug. Mean duration of exposure to double-blind study drug was 1.7 years in each treatment group.

Eligibility
Key inclusion criteria
- Males and females = 18 yrs with atrial fibrillation (AF) and one or more of the
following risk factors for stroke:

- Age = 75, previous stroke

- transient ischemic attack (TIA) or Systemic Embolism (SE)

- Symptomatic congestive heart failure or left ventricular dysfunction with left
ventricular ejection fraction (LVEF) = 40%

- Diabetes mellitus or hypertension requiring pharmacological treatment
Minimum age
No limit
Maximum age
No limit
Sex
Both males and females
Can healthy volunteers participate?
No
Key exclusion criteria

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 analysing the results/data
Intervention assignment
Parallel
Other design features
Phase
Phase 3
Type of endpoint/s
Statistical methods / analysis

Recruitment
Recruitment status
Completed
Data analysis
Reason for early stopping/withdrawal
Other reasons
Date of first participant enrolment
Anticipated
Actual
31/12/2006
Date of last participant enrolment
Anticipated
Actual
Date of last data collection
Anticipated
Actual
25/05/2011
Sample size
Target
Accrual to date
Final
20976
Recruitment in Australia
Recruitment state(s)
NSW,QLD,SA,VIC,WA
Recruitment hospital [1] 0 0
Local Institution - Coffs Harbour
Recruitment hospital [2] 0 0
Local Institution - Concord
Recruitment hospital [3] 0 0
Local Institution - Gosford
Recruitment hospital [4] 0 0
Local Institution - Kogarah
Recruitment hospital [5] 0 0
Local Institution - Miranda
Recruitment hospital [6] 0 0
Local Institution - Auchenflower
Recruitment hospital [7] 0 0
Local Institution - Brisbane
Recruitment hospital [8] 0 0
Local Institution - Caboolture
Recruitment hospital [9] 0 0
Local Institution - Herston
Recruitment hospital [10] 0 0
Local Institution - Kippa Ring
Recruitment hospital [11] 0 0
Local Institution - Nambour
Recruitment hospital [12] 0 0
Local Institution - Sherwood
Recruitment hospital [13] 0 0
Local Institution - Adelaide
Recruitment hospital [14] 0 0
Local Institution - Ashford
Recruitment hospital [15] 0 0
Local Institution - Bedford Park
Recruitment hospital [16] 0 0
Local Institution - Woodville
Recruitment hospital [17] 0 0
Local Institution - Box Hill
Recruitment hospital [18] 0 0
Local Institution - Dandenong
Recruitment hospital [19] 0 0
Local Institution - Geelong
Recruitment hospital [20] 0 0
Local Institution - Fremantle
Recruitment hospital [21] 0 0
Local Institution - Joondalup
Recruitment postcode(s) [1] 0 0
2450 - Coffs Harbour
Recruitment postcode(s) [2] 0 0
2139 - Concord
Recruitment postcode(s) [3] 0 0
2250 - Gosford
Recruitment postcode(s) [4] 0 0
2217 - Kogarah
Recruitment postcode(s) [5] 0 0
2228 - Miranda
Recruitment postcode(s) [6] 0 0
4066 - Auchenflower
Recruitment postcode(s) [7] 0 0
4032 - Brisbane
Recruitment postcode(s) [8] 0 0
4510 - Caboolture
Recruitment postcode(s) [9] 0 0
4029 - Herston
Recruitment postcode(s) [10] 0 0
4021 - Kippa Ring
Recruitment postcode(s) [11] 0 0
4560 - Nambour
Recruitment postcode(s) [12] 0 0
4075 - Sherwood
Recruitment postcode(s) [13] 0 0
SA 5000 - Adelaide
Recruitment postcode(s) [14] 0 0
5035 - Ashford
Recruitment postcode(s) [15] 0 0
5042 - Bedford Park
Recruitment postcode(s) [16] 0 0
5011 - Woodville
Recruitment postcode(s) [17] 0 0
3128 - Box Hill
Recruitment postcode(s) [18] 0 0
3175 - Dandenong
Recruitment postcode(s) [19] 0 0
3220 - Geelong
Recruitment postcode(s) [20] 0 0
6160 - Fremantle
Recruitment postcode(s) [21] 0 0
6027 - Joondalup
Recruitment outside Australia
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Germany
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Germany
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Germany
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Germany
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Germany
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Germany
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Germany
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Germany
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Germany
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Germany
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Germany
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Germany
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Germany
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Germany
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Germany
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Trier
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Germany
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Germany
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Germany
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Germany
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Hong Kong
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Hungary
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Hungary
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Hungary
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Gyor
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Hungary
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Hungary
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Hodmezovasarhely
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Hungary
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Komarom
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Hungary
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Hungary
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Oroshaza
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Hungary
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Pecs
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Hungary
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Siofok
Country [209] 0 0
Hungary
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Sopron
Country [210] 0 0
Hungary
State/province [210] 0 0
Szentes
Country [211] 0 0
Hungary
State/province [211] 0 0
Zalaegerszeg
Country [212] 0 0
India
State/province [212] 0 0
Andhra Pradesh
Country [213] 0 0
India
State/province [213] 0 0
Andhrapradesh
Country [214] 0 0
India
State/province [214] 0 0
Andra Pradesh
Country [215] 0 0
India
State/province [215] 0 0
Gujarat
Country [216] 0 0
India
State/province [216] 0 0
Karnataka
Country [217] 0 0
India
State/province [217] 0 0
Kerela
Country [218] 0 0
India
State/province [218] 0 0
Maharashta
Country [219] 0 0
India
State/province [219] 0 0
Maharashtra
Country [220] 0 0
India
State/province [220] 0 0
Punjab
Country [221] 0 0
India
State/province [221] 0 0
Rajasthan
Country [222] 0 0
India
State/province [222] 0 0
Uttar Pradesh
Country [223] 0 0
India
State/province [223] 0 0
Ahmedabad
Country [224] 0 0
India
State/province [224] 0 0
Annamalainagar
Country [225] 0 0
India
State/province [225] 0 0
Bangalore
Country [226] 0 0
India
State/province [226] 0 0
Chennai
Country [227] 0 0
India
State/province [227] 0 0
Hyderabad
Country [228] 0 0
India
State/province [228] 0 0
Indore
Country [229] 0 0
India
State/province [229] 0 0
Kolkata
Country [230] 0 0
India
State/province [230] 0 0
Kottayam
Country [231] 0 0
India
State/province [231] 0 0
Lucknow
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India
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Mumbai Naka
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India
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Nashik
Country [234] 0 0
India
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New Delhi
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India
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Pune
Country [236] 0 0
India
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Thrissur
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India
State/province [237] 0 0
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Israel
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Afula
Country [239] 0 0
Israel
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Ashkelon
Country [240] 0 0
Israel
State/province [240] 0 0
Givatayim
Country [241] 0 0
Israel
State/province [241] 0 0
Hadera
Country [242] 0 0
Israel
State/province [242] 0 0
Haifa
Country [243] 0 0
Israel
State/province [243] 0 0
Holon
Country [244] 0 0
Israel
State/province [244] 0 0
Jerusalem
Country [245] 0 0
Israel
State/province [245] 0 0
Kfar-Saba
Country [246] 0 0
Israel
State/province [246] 0 0
Nazareth
Country [247] 0 0
Israel
State/province [247] 0 0
Petach-Tikva
Country [248] 0 0
Israel
State/province [248] 0 0
Safed
Country [249] 0 0
Israel
State/province [249] 0 0
Tel Aviv
Country [250] 0 0
Italy
State/province [250] 0 0
Lucca
Country [251] 0 0
Italy
State/province [251] 0 0
Ascoli Piceno
Country [252] 0 0
Italy
State/province [252] 0 0
Campobasso
Country [253] 0 0
Italy
State/province [253] 0 0
Chieti
Country [254] 0 0
Italy
State/province [254] 0 0
Cremona
Country [255] 0 0
Italy
State/province [255] 0 0
Fidenza (Pr)
Country [256] 0 0
Italy
State/province [256] 0 0
Genova
Country [257] 0 0
Italy
State/province [257] 0 0
Isernia
Country [258] 0 0
Italy
State/province [258] 0 0
Livorno
Country [259] 0 0
Italy
State/province [259] 0 0
Milano
Country [260] 0 0
Italy
State/province [260] 0 0
Napoli
Country [261] 0 0
Italy
State/province [261] 0 0
Palermo
Country [262] 0 0
Italy
State/province [262] 0 0
Reggio Emilia
Country [263] 0 0
Italy
State/province [263] 0 0
Roma
Country [264] 0 0
Italy
State/province [264] 0 0
San Daniele De Friuli
Country [265] 0 0
Italy
State/province [265] 0 0
Torino
Country [266] 0 0
Italy
State/province [266] 0 0
Vittorio Veneto (Tv)
Country [267] 0 0
Japan
State/province [267] 0 0
Fukuoka
Country [268] 0 0
Japan
State/province [268] 0 0
Fukushima
Country [269] 0 0
Japan
State/province [269] 0 0
Gunma
Country [270] 0 0
Japan
State/province [270] 0 0
Hokkaido
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Japan
State/province [271] 0 0
Hyogo
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Japan
State/province [272] 0 0
Kagoshima Prefecture
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Japan
State/province [273] 0 0
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Japan
State/province [274] 0 0
Miyagi
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Japan
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Nara
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Japan
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Japan
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Saga
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Japan
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Japan
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Japan
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Japan
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Japan
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Japan
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Japan
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Japan
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Japan
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Korea, Republic of
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Korea, Republic of
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Korea, Republic of
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Korea, Republic of
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Korea, Republic of
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Korea, Republic of
State/province [295] 0 0
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Korea, Republic of
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Scongnam-Si
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Korea, Republic of
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Korea, Republic of
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Mexico
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Mexico
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Mexico
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Mexico
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Mexico
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Mexico
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Mexico
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Mexico
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Philippines
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Poland
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Poland
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Poland
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Poland
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Poland
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Poland
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Poland
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Poland
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Poland
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Ruda Slaska
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Poland
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Poland
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Poland
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Poland
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Poland
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Puerto Rico
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Puerto Rico
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Baia Mare
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Romania
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Cluj Napoca
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Romania
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Romania
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Romania
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Romania
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Romania
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Romania
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Tirgu Mures
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Russian Federation
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Russian Federation
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Chita
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Russian Federation
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Dzerzhinskiy
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Russian Federation
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Russian Federation
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Russian Federation
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Russian Federation
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Krasnodar
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Russian Federation
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Moscow
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Russian Federation
State/province [382] 0 0
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Russian Federation
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Russian Federation
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Odintsovo
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Russian Federation
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Penza
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Russian Federation
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Perm
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Russian Federation
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Rostov-On-Don
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Russian Federation
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Russian Federation
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Saint Petersburg
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Russian Federation
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Saint-Petersburg
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Russian Federation
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Russian Federation
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Russian Federation
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St Petersburg
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Russian Federation
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Russian Federation
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St. Petersburg
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Russian Federation
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Russian Federation
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Russian Federation
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Tomsk
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Russian Federation
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Tumen
Country [400] 0 0
Russian Federation
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Tver
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Russian Federation
State/province [401] 0 0
Voronezh
Country [402] 0 0
Russian Federation
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Yaroslavl
Country [403] 0 0
Russian Federation
State/province [403] 0 0
Zheleznodorozhniy
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Russian Federation
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Zhukovsky
Country [405] 0 0
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Singapore
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South Africa
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Cape Town
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South Africa
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Gauteng
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South Africa
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KWA ZULU Natal
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South Africa
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Western CAPE
Country [411] 0 0
Spain
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Country [412] 0 0
Spain
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Country [413] 0 0
Spain
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Galicia
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Spain
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Country [415] 0 0
Spain
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Barcelona
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Spain
State/province [416] 0 0
Elda
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Spain
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Spain
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Spain
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Spain
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Madrid
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Spain
State/province [421] 0 0
Palma De Mallorca
Country [422] 0 0
Spain
State/province [422] 0 0
San Sebastian De Los Reyes
Country [423] 0 0
Spain
State/province [423] 0 0
Tarragona
Country [424] 0 0
Spain
State/province [424] 0 0
Viladecans
Country [425] 0 0
Sweden
State/province [425] 0 0
Goteberg
Country [426] 0 0
Sweden
State/province [426] 0 0
Helsingborg
Country [427] 0 0
Sweden
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Linkoping
Country [428] 0 0
Sweden
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Lund
Country [429] 0 0
Sweden
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Orebro
Country [430] 0 0
Sweden
State/province [430] 0 0
Skelleftea
Country [431] 0 0
Sweden
State/province [431] 0 0
Stockholm
Country [432] 0 0
Sweden
State/province [432] 0 0
Uppsala
Country [433] 0 0
Sweden
State/province [433] 0 0
Vaxjo
Country [434] 0 0
Switzerland
State/province [434] 0 0
Baden
Country [435] 0 0
Switzerland
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Bern
Country [436] 0 0
Taiwan
State/province [436] 0 0
Taipei
Country [437] 0 0
Turkey
State/province [437] 0 0
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Country [438] 0 0
Turkey
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Eskisehir
Country [439] 0 0
Turkey
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Izmir
Country [440] 0 0
Ukraine
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Chernivtsy
Country [441] 0 0
Ukraine
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Dnipropetrovsk
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Ukraine
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Donetsk
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Ukraine
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Ivano-Frankivsk
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Ukraine
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Kharkiv
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Ukraine
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Kharkov
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Ukraine
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Kiev
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Ukraine
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Ukraine
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Lugansk
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Ukraine
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Lutsk
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Ukraine
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Lviv
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Ukraine
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Mykolayiv
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Ukraine
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Odessa
Country [453] 0 0
Ukraine
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Uzhgorod
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Ukraine
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Country [455] 0 0
Ukraine
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Zaporozhye
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Ukraine
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Zhytomyr
Country [457] 0 0
United Kingdom
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Country [458] 0 0
United Kingdom
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Antrim
Country [459] 0 0
United Kingdom
State/province [459] 0 0
Armagh
Country [460] 0 0
United Kingdom
State/province [460] 0 0
Cambridgeshire
Country [461] 0 0
United Kingdom
State/province [461] 0 0
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Country [462] 0 0
United Kingdom
State/province [462] 0 0
Dorset
Country [463] 0 0
United Kingdom
State/province [463] 0 0
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Country [464] 0 0
United Kingdom
State/province [464] 0 0
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Country [465] 0 0
United Kingdom
State/province [465] 0 0
Essex
Country [466] 0 0
United Kingdom
State/province [466] 0 0
Greater London
Country [467] 0 0
United Kingdom
State/province [467] 0 0
Gwent
Country [468] 0 0
United Kingdom
State/province [468] 0 0
Hertfordshire
Country [469] 0 0
United Kingdom
State/province [469] 0 0
MID Glamorgan
Country [470] 0 0
United Kingdom
State/province [470] 0 0
Middlesex
Country [471] 0 0
United Kingdom
State/province [471] 0 0
Nottinghamshire
Country [472] 0 0
United Kingdom
State/province [472] 0 0
Renfrewshire
Country [473] 0 0
United Kingdom
State/province [473] 0 0
South Yorkshire
Country [474] 0 0
United Kingdom
State/province [474] 0 0
Stirlingshire
Country [475] 0 0
United Kingdom
State/province [475] 0 0
Strathclyde
Country [476] 0 0
United Kingdom
State/province [476] 0 0
Suffolk
Country [477] 0 0
United Kingdom
State/province [477] 0 0
Tyne and Wear
Country [478] 0 0
United Kingdom
State/province [478] 0 0
WEST Glamorgan
Country [479] 0 0
United Kingdom
State/province [479] 0 0
WEST Lothian
Country [480] 0 0
United Kingdom
State/province [480] 0 0
WEST Midlands
Country [481] 0 0
United Kingdom
State/province [481] 0 0
Wiltshire
Country [482] 0 0
United Kingdom
State/province [482] 0 0
Yorkshire
Country [483] 0 0
United Kingdom
State/province [483] 0 0
Blackpool
Country [484] 0 0
United Kingdom
State/province [484] 0 0
Glasgow

Funding & Sponsors
Primary sponsor type
Commercial sector/Industry
Name
Bristol-Myers Squibb
Address
Country

Ethics approval
Ethics application status

Summary
Brief summary
The trial seeks to determine if apixaban, an investigational anticoagulant (blood-thinner) is
as effective as standard therapy (warfarin) in preventing stroke and systemic embolism in
subjects with atrial fibrillation and risk factors for stroke.
Trial website
https://clinicaltrials.gov/ct2/show/NCT00412984
Trial related presentations / publications
Public notes

Contacts
Principal investigator
Name 0 0
Bristol-Myers Squibb
Address 0 0
Bristol-Myers Squibb
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/ct2/show/NCT00412984