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Trial details imported from ClinicalTrials.gov

For full trial details, please see the original record at https://clinicaltrials.gov/study/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
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,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
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Local Institution - Box Hill
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Local Institution - Dandenong
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Local Institution - Geelong
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Local Institution - Fremantle
Recruitment hospital [21] 0 0
Local Institution - Joondalup
Recruitment postcode(s) [1] 0 0
2450 - Coffs Harbour
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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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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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Hungary
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Hungary
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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
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Country [212] 0 0
India
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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
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Country [228] 0 0
India
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Indore
Country [229] 0 0
India
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Kolkata
Country [230] 0 0
India
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Kottayam
Country [231] 0 0
India
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Lucknow
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India
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Mumbai Naka
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India
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Nashik
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India
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New Delhi
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India
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Pune
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India
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Thrissur
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India
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Israel
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Country [239] 0 0
Israel
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Ashkelon
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Israel
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Country [241] 0 0
Israel
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Hadera
Country [242] 0 0
Israel
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Haifa
Country [243] 0 0
Israel
State/province [243] 0 0
Holon
Country [244] 0 0
Israel
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Jerusalem
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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
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Lucca
Country [251] 0 0
Italy
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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
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Genova
Country [257] 0 0
Italy
State/province [257] 0 0
Isernia
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Italy
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Livorno
Country [259] 0 0
Italy
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Milano
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Italy
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Napoli
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Italy
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Palermo
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Italy
State/province [262] 0 0
Reggio Emilia
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Italy
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Roma
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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)
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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
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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
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Japan
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Miyagi
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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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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
State/province [295] 0 0
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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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Malaysia
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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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Philippines
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Philippines
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Philippines
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Philippines
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Philippines
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Poland
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Grodzisk Mazowiecki
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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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Piotrkow Trybunalski
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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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Ponce
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Romania
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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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Sibiu
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Romania
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Targu-Mures
Country [372] 0 0
Romania
State/province [372] 0 0
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