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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
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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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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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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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
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Hungary
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Sopron
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Hungary
State/province [210] 0 0
Szentes
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Hungary
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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
Hyderabad
Country [228] 0 0
India
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Indore
Country [229] 0 0
India
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Kolkata
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India
State/province [230] 0 0
Kottayam
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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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Israel
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Ashkelon
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Israel
State/province [240] 0 0
Givatayim
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
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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
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Safed
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Israel
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Tel Aviv
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Lucca
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Italy
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Ascoli Piceno
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Italy
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Campobasso
Country [253] 0 0
Italy
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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
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Italy
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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
State/province [261] 0 0
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
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Fukuoka
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Japan
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Fukushima
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Japan
State/province [269] 0 0
Gunma
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Japan
State/province [270] 0 0
Hokkaido
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Japan
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Hyogo
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Japan
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Kagoshima Prefecture
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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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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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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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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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Russian Federation
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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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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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Russian Federation
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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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Russian Federation
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Russian Federation
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Russian Federation
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Russian Federation
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Tumen
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Russian Federation
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Tver
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Russian Federation
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Voronezh
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Russian Federation
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Yaroslavl
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Russian Federation
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Zheleznodorozhniy
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Russian Federation
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Zhukovsky
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South Africa
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Gauteng
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South Africa
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South Africa
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Western CAPE
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Spain
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Country [412] 0 0
Spain
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Spain
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Spain
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Spain
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Barcelona
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Spain
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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
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Spain
State/province [422] 0 0
San Sebastian De Los Reyes
Country [423] 0 0
Spain
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Tarragona
Country [424] 0 0
Spain
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Viladecans
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Sweden
State/province [425] 0 0
Goteberg
Country [426] 0 0
Sweden
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Helsingborg
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Sweden
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Linkoping
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Sweden
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Lund
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Sweden
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Sweden
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Country [431] 0 0
Sweden
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Country [432] 0 0
Sweden
State/province [432] 0 0
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Country [433] 0 0
Sweden
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Vaxjo
Country [434] 0 0
Switzerland
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Baden
Country [435] 0 0
Switzerland
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Bern
Country [436] 0 0
Taiwan
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Taipei
Country [437] 0 0
Turkey
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Country [438] 0 0
Turkey
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Eskisehir
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Turkey
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Izmir
Country [440] 0 0
Ukraine
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Chernivtsy
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Ukraine
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Ukraine
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Ukraine
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Ukraine
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Kharkiv
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Ukraine
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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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Ukraine
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Ukraine
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Ukraine
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Odessa
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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
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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
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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
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Country [463] 0 0
United Kingdom
State/province [463] 0 0
Dumbartonshire
Country [464] 0 0
United Kingdom
State/province [464] 0 0
EAST Sussex
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/study/NCT00412984
Trial related presentations / publications
Jamieson MJ, Byon W, Dettloff RW, Crawford M, Gargalovic PS, Merali SJ, Onorato J, Quintero AJ, Russ C. Apixaban Use in Obese Patients: A Review of the Pharmacokinetic, Interventional, and Observational Study Data. Am J Cardiovasc Drugs. 2022 Nov;22(6):615-631. doi: 10.1007/s40256-022-00524-x. Epub 2022 May 16.
Pol T, Hijazi Z, Lindback J, Oldgren J, Alexander JH, Connolly SJ, Eikelboom JW, Ezekowitz MD, Granger CB, Lopes RD, Yusuf S, Siegbahn A, Wallentin L. Using multimarker screening to identify biomarkers associated with cardiovascular death in patients with atrial fibrillation. Cardiovasc Res. 2022 Jul 20;118(9):2112-2123. doi: 10.1093/cvr/cvab262.
Pol T, Hijazi Z, Lindback J, Alexander JH, Bahit MC, De Caterina R, Eikelboom JW, Ezekowitz MD, Gersh BJ, Granger CB, Hylek EM, Lopes R, Siegbahn A, Wallentin L. Evaluation of the prognostic value of GDF-15, ABC-AF-bleeding score and ABC-AF-death score in patients with atrial fibrillation across different geographical areas. Open Heart. 2021 Mar;8(1):e001471. doi: 10.1136/openhrt-2020-001471.
Hijazi Z, Wallentin L, Lindback J, Alexander JH, Connolly SJ, Eikelboom JW, Ezekowitz MD, Granger CB, Lopes RD, Pol T, Yusuf S, Oldgren J, Siegbahn A. Screening of Multiple Biomarkers Associated With Ischemic Stroke in Atrial Fibrillation. J Am Heart Assoc. 2020 Dec 15;9(24):e018984. doi: 10.1161/JAHA.120.018984. Epub 2020 Dec 9.
Wallentin L, Lindback J, Eriksson N, Hijazi Z, Eikelboom JW, Ezekowitz MD, Granger CB, Lopes RD, Yusuf S, Oldgren J, Siegbahn A. Angiotensin-converting enzyme 2 (ACE2) levels in relation to risk factors for COVID-19 in two large cohorts of patients with atrial fibrillation. Eur Heart J. 2020 Nov 1;41(41):4037-4046. doi: 10.1093/eurheartj/ehaa697.
Hijazi Z, Granger CB, Hohnloser SH, Westerbergh J, Lindback J, Alexander JH, Keltai M, Parkhomenko A, Lopez-Sendon JL, Lopes RD, Siegbahn A, Wallentin L. Association of Different Estimates of Renal Function With Cardiovascular Mortality and Bleeding in Atrial Fibrillation. J Am Heart Assoc. 2020 Sep 15;9(18):e017155. doi: 10.1161/JAHA.120.017155. Epub 2020 Aug 31.
Zeitouni M, Giczewska A, Alexander JH. Reply: Specifics of Dose Modification in ARISTOTLE. J Am Coll Cardiol. 2020 Jul 7;76(1):128-129. doi: 10.1016/j.jacc.2020.05.013. No abstract available.
Rosjo H, Hijazi Z, Omland T, Westerbergh J, Lyngbakken MN, Alexander JH, Gersh BJ, Granger CB, Hylek EM, Lopes RD, Siegbahn A, Wallentin L. Cardiac troponin is associated with cardiac outcomes in men and women with atrial fibrillation, insights from the ARISTOTLE trial. J Intern Med. 2020 Aug;288(2):248-259. doi: 10.1111/joim.13072. Epub 2020 May 18.
Zeitouni M, Giczewska A, Lopes RD, Wojdyla DM, Christersson C, Siegbahn A, De Caterina R, Steg PG, Granger CB, Wallentin L, Alexander JH; ARISTOTLE Investigators. Clinical and Pharmacological Effects of Apixaban Dose Adjustment in the ARISTOTLE Trial. J Am Coll Cardiol. 2020 Mar 17;75(10):1145-1155. doi: 10.1016/j.jacc.2019.12.060.
Stanifer JW, Pokorney SD, Chertow GM, Hohnloser SH, Wojdyla DM, Garonzik S, Byon W, Hijazi Z, Lopes RD, Alexander JH, Wallentin L, Granger CB. Apixaban Versus Warfarin in Patients With Atrial Fibrillation and Advanced Chronic Kidney Disease. Circulation. 2020 Apr 28;141(17):1384-1392. doi: 10.1161/CIRCULATIONAHA.119.044059. Epub 2020 Mar 12.
Garcia DA, Fisher DA, Mulder H, Wruck L, De Caterina R, Halvorsen S, Granger CB, Held C, Wallentin L, Alexander JH, Lopes RD. Gastrointestinal bleeding in patients with atrial fibrillation treated with Apixaban or warfarin: Insights from the Apixaban for Reduction in Stroke and Other Thromboembolic Events in Atrial Fibrillation (ARISTOTLE) trial. Am Heart J. 2020 Mar;221:1-8. doi: 10.1016/j.ahj.2019.10.013. Epub 2019 Oct 31.
Dalgaard F, Mulder H, Wojdyla DM, Lopes RD, Held C, Alexander JH, De Caterina R, Washam JB, Hylek EM, Garcia DA, Gersh BJ, Wallentin L, Granger CB, Al-Khatib SM. Patients With Atrial Fibrillation Taking Nonsteroidal Anti-Inflammatory Drugs and Oral Anticoagulants in the ARISTOTLE Trial. Circulation. 2020 Jan 7;141(1):10-20. doi: 10.1161/CIRCULATIONAHA.119.041296. Epub 2019 Nov 21.
Goldstein SA, Green J, Huber K, Wojdyla DM, Lopes RD, Alexander JH, Vinereanu D, Wallentin L, Granger CB, Al-Khatib SM. Characteristics and Outcomes of Atrial Fibrillation in Patients With Thyroid Disease (from the ARISTOTLE Trial). Am J Cardiol. 2019 Nov 1;124(9):1406-1412. doi: 10.1016/j.amjcard.2019.07.046. Epub 2019 Aug 7.
Guimaraes PO, Pokorney SD, Lopes RD, Wojdyla DM, Gersh BJ, Giczewska A, Carnicelli A, Lewis BS, Hanna M, Wallentin L, Vinereanu D, Alexander JH, Granger CB. Efficacy and safety of apixaban vs warfarin in patients with atrial fibrillation and prior bioprosthetic valve replacement or valve repair: Insights from the ARISTOTLE trial. Clin Cardiol. 2019 May;42(5):568-571. doi: 10.1002/clc.23178. Epub 2019 Apr 9.
Washam JB, Hohnloser SH, Lopes RD, Wojdyla DM, Vinereanu D, Alexander JH, Gersh BJ, Hanna M, Horowitz J, Hylek EM, Xavier D, Verheugt FWA, Wallentin L, Granger CB; ARISTOTLE Committees and Investigators. Interacting medication use and the treatment effects of apixaban versus warfarin: results from the ARISTOTLE Trial. J Thromb Thrombolysis. 2019 Apr;47(3):345-352. doi: 10.1007/s11239-019-01823-y.
Hohnloser SH, Fudim M, Alexander JH, Wojdyla DM, Ezekowitz JA, Hanna M, Atar D, Hijazi Z, Bahit MC, Al-Khatib SM, Lopez-Sendon JL, Wallentin L, Granger CB, Lopes RD. Efficacy and Safety of Apixaban Versus Warfarin in Patients With Atrial Fibrillation and Extremes in Body Weight. Circulation. 2019 May 14;139(20):2292-2300. doi: 10.1161/CIRCULATIONAHA.118.037955.
Alexander KP, Brouwer MA, Mulder H, Vinereanu D, Lopes RD, Proietti M, Al-Khatib SM, Hijazi Z, Halvorsen S, Hylek EM, Verheugt FWA, Alexander JH, Wallentin L, Granger CB; ARISTOTLE Investigators. Outcomes of apixaban versus warfarin in patients with atrial fibrillation and multi-morbidity: Insights from the ARISTOTLE trial. Am Heart J. 2019 Feb;208:123-131. doi: 10.1016/j.ahj.2018.09.017. Epub 2018 Nov 22.
Sandhu RK, Ezekowitz JA, Hijazi Z, Westerbergh J, Aulin J, Alexander JH, Granger CB, Halvorsen S, Hanna MS, Lopes RD, Siegbahn A, Wallentin L. Obesity paradox on outcome in atrial fibrillation maintained even considering the prognostic influence of biomarkers: insights from the ARISTOTLE trial. Open Heart. 2018 Nov 1;5(2):e000908. doi: 10.1136/openhrt-2018-000908. eCollection 2018.
Christersson C, Wallentin L, Andersson U, Alexander JH, Alings M, De Caterina R, Gersh BJ, Granger CB, Halvorsen S, Hanna M, Huber K, Hylek EM, Lopes RD, Oh BH, Siegbahn A. Effect of apixaban compared with warfarin on coagulation markers in atrial fibrillation. Heart. 2019 Feb;105(3):235-242. doi: 10.1136/heartjnl-2018-313351. Epub 2018 Sep 12.
Horowitz JD, De Caterina R, Heresztyn T, Alexander JH, Andersson U, Lopes RD, Steg PG, Hylek EM, Mohan P, Hanna M, Jansky P, Granger CB, Wallentin L; ARISTOTLE Investigators. Asymmetric and Symmetric Dimethylarginine Predict Outcomes in Patients With Atrial Fibrillation: An ARISTOTLE Substudy. J Am Coll Cardiol. 2018 Aug 14;72(7):721-733. doi: 10.1016/j.jacc.2018.05.058.
Sharma A, Hijazi Z, Andersson U, Al-Khatib SM, Lopes RD, Alexander JH, Held C, Hylek EM, Leonardi S, Hanna M, Ezekowitz JA, Siegbahn A, Granger CB, Wallentin L. Use of Biomarkers to Predict Specific Causes of Death in Patients With Atrial Fibrillation. Circulation. 2018 Oct 16;138(16):1666-1676. doi: 10.1161/CIRCULATIONAHA.118.034125.
Kopin D, Jones WS, Sherwood MW, Wojdyla DM, Wallentin L, Lewis BS, Verheugt FWA, Vinereanu D, Bahit MC, Halvorsen S, Huber K, Parkhomenko A, Granger CB, Lopes RD, Alexander JH. Percutaneous coronary intervention and antiplatelet therapy in patients with atrial fibrillation receiving apixaban or warfarin: Insights from the ARISTOTLE trial. Am Heart J. 2018 Mar;197:133-141. doi: 10.1016/j.ahj.2017.11.005. Epub 2017 Nov 10.
Pol T, Held C, Westerbergh J, Lindback J, Alexander JH, Alings M, Erol C, Goto S, Halvorsen S, Huber K, Hanna M, Lopes RD, Ruzyllo W, Granger CB, Hijazi Z. Dyslipidemia and Risk of Cardiovascular Events in Patients With Atrial Fibrillation Treated With Oral Anticoagulation Therapy: Insights From the ARISTOTLE (Apixaban for Reduction in Stroke and Other Thromboembolic Events in Atrial Fibrillation) Trial. J Am Heart Assoc. 2018 Feb 1;7(3):e007444. doi: 10.1161/JAHA.117.007444.
Goto S, Merrill P, Wallentin L, Wojdyla DM, Hanna M, Avezum A, Easton JD, Harjola VP, Huber K, Lewis BS, Parkhomenko A, Zhu J, Granger CB, Lopes RD, Alexander JH. Antithrombotic therapy use and clinical outcomes following thrombo-embolic events in patients with atrial fibrillation: insights from ARISTOTLE. Eur Heart J Cardiovasc Pharmacother. 2018 Apr 1;4(2):75-81. doi: 10.1093/ehjcvp/pvy002.
Vinereanu D, Wang A, Mulder H, Lopes RD, Jansky P, Lewis BS, Gersh BJ, Avezum A, Hanna M, Held C, Wallentin L, Granger CB, Alexander JH. Outcomes in anticoagulated patients with atrial fibrillation and with mitral or aortic valve disease. Heart. 2018 Aug;104(15):1292-1299. doi: 10.1136/heartjnl-2017-312272. Epub 2018 Jan 19.
Rao MP, Vinereanu D, Wojdyla DM, Alexander JH, Atar D, Hylek EM, Hanna M, Wallentin L, Lopes RD, Gersh BJ, Granger CB; Apixaban for Reduction in Stroke Other Thromboembolic Events in Atrial Fibrillation (ARISTOTLE) Investigators. Clinical Outcomes and History of Fall in Patients with Atrial Fibrillation Treated with Oral Anticoagulation: Insights From the ARISTOTLE Trial. Am J Med. 2018 Mar;131(3):269-275.e2. doi: 10.1016/j.amjmed.2017.10.036. Epub 2017 Nov 6.
Vinereanu D, Lopes RD, Mulder H, Gersh BJ, Hanna M, de Barros E Silva PGM, Atar D, Wallentin L, Granger CB, Alexander JH; ARISTOTLE Investigators. Echocardiographic Risk Factors for Stroke and Outcomes in Patients With Atrial Fibrillation Anticoagulated With Apixaban or Warfarin. Stroke. 2017 Dec;48(12):3266-3273. doi: 10.1161/STROKEAHA.117.017574. Epub 2017 Oct 31.
Hijazi Z, Oldgren J, Lindback J, Alexander JH, Connolly SJ, Eikelboom JW, Ezekowitz MD, Held C, Hylek EM, Lopes RD, Yusuf S, Granger CB, Siegbahn A, Wallentin L; ARISTOTLE and RE-LY Investigators. A biomarker-based risk score to predict death in patients with atrial fibrillation: the ABC (age, biomarkers, clinical history) death risk score. Eur Heart J. 2018 Feb 7;39(6):477-485. doi: 10.1093/eurheartj/ehx584.
Hijazi Z, Lindahl B, Oldgren J, Andersson U, Lindback J, Granger CB, Alexander JH, Gersh BJ, Hanna M, Harjola VP, Hylek EM, Lopes RD, Siegbahn A, Wallentin L. Repeated Measurements of Cardiac Biomarkers in Atrial Fibrillation and Validation of the ABC Stroke Score Over Time. J Am Heart Assoc. 2017 Jun 23;6(6):e004851. doi: 10.1161/JAHA.116.004851.
Lopes RD, Guimaraes PO, Kolls BJ, Wojdyla DM, Bushnell CD, Hanna M, Easton JD, Thomas L, Wallentin L, Al-Khatib SM, Held C, Gabriel Melo de Barros E Silva P, Alexander JH, Granger CB, Diener HC. Intracranial hemorrhage in patients with atrial fibrillation receiving anticoagulation therapy. Blood. 2017 Jun 1;129(22):2980-2987. doi: 10.1182/blood-2016-08-731638. Epub 2017 Mar 29.
Cowper PA, Sheng S, Lopes RD, Anstrom KJ, Stafford JA, Davidson-Ray L, Al-Khatib SM, Ansell J, Dorian P, Husted S, McMurray JJV, Steg PG, Alexander JH, Wallentin L, Granger CB, Mark DB. Economic Analysis of Apixaban Therapy for Patients With Atrial Fibrillation From a US Perspective: Results From the ARISTOTLE Randomized Clinical Trial. JAMA Cardiol. 2017 May 1;2(5):525-534. doi: 10.1001/jamacardio.2017.0065.
Hu PT, Lopes RD, Stevens SR, Wallentin L, Thomas L, Alexander JH, Hanna M, Lewis BS, Verheugt FW, Granger CB, Jones WS. Efficacy and Safety of Apixaban Compared With Warfarin in Patients With Atrial Fibrillation and Peripheral Artery Disease: Insights From the ARISTOTLE Trial. J Am Heart Assoc. 2017 Jan 17;6(1):e004699. doi: 10.1161/JAHA.116.004699.
Bahit MC, Lopes RD, Wojdyla DM, Held C, Hanna M, Vinereanu D, Hylek EM, Verheugt F, Goto S, Alexander JH, Wallentin L, Granger CB. Non-major bleeding with apixaban versus warfarin in patients with atrial fibrillation. Heart. 2017 Apr;103(8):623-628. doi: 10.1136/heartjnl-2016-309901. Epub 2016 Oct 24.
Oldgren J, Hijazi Z, Lindback J, Alexander JH, Connolly SJ, Eikelboom JW, Ezekowitz MD, Granger CB, Hylek EM, Lopes RD, Siegbahn A, Yusuf S, Wallentin L; RE-LY and ARISTOTLE Investigators. Performance and Validation of a Novel Biomarker-Based Stroke Risk Score for Atrial Fibrillation. Circulation. 2016 Nov 29;134(22):1697-1707. doi: 10.1161/CIRCULATIONAHA.116.022802. Epub 2016 Aug 28.
Alexander JH, Andersson U, Lopes RD, Hijazi Z, Hohnloser SH, Ezekowitz JA, Halvorsen S, Hanna M, Commerford P, Ruzyllo W, Huber K, Al-Khatib SM, Granger CB, Wallentin L; Apixaban for Reduction of Stroke and Other Thromboembolic Complications in Atrial Fibrillation (ARISTOTLE) Investigators. Apixaban 5 mg Twice Daily and Clinical Outcomes in Patients With Atrial Fibrillation and Advanced Age, Low Body Weight, or High Creatinine: A Secondary Analysis of a Randomized Clinical Trial. JAMA Cardiol. 2016 Sep 1;1(6):673-81. doi: 10.1001/jamacardio.2016.1829.
Hijazi Z, Hohnloser SH, Andersson U, Alexander JH, Hanna M, Keltai M, Parkhomenko A, Lopez-Sendon JL, Lopes RD, Siegbahn A, Granger CB, Wallentin L. Efficacy and Safety of Apixaban Compared With Warfarin in Patients With Atrial Fibrillation in Relation to Renal Function Over Time: Insights From the ARISTOTLE Randomized Clinical Trial. JAMA Cardiol. 2016 Jul 1;1(4):451-60. doi: 10.1001/jamacardio.2016.1170.
Jaspers Focks J, Brouwer MA, Wojdyla DM, Thomas L, Lopes RD, Washam JB, Lanas F, Xavier D, Husted S, Wallentin L, Alexander JH, Granger CB, Verheugt FW. Polypharmacy and effects of apixaban versus warfarin in patients with atrial fibrillation: post hoc analysis of the ARISTOTLE trial. BMJ. 2016 Jun 15;353:i2868. doi: 10.1136/bmj.i2868.
Hijazi Z, Oldgren J, Lindback J, Alexander JH, Connolly SJ, Eikelboom JW, Ezekowitz MD, Held C, Hylek EM, Lopes RD, Siegbahn A, Yusuf S, Granger CB, Wallentin L; ARISTOTLE and RE-LY Investigators. The novel biomarker-based ABC (age, biomarkers, clinical history)-bleeding risk score for patients with atrial fibrillation: a derivation and validation study. Lancet. 2016 Jun 4;387(10035):2302-2311. doi: 10.1016/S0140-6736(16)00741-8. Epub 2016 Apr 4.
Hijazi Z, Lindback J, Alexander JH, Hanna M, Held C, Hylek EM, Lopes RD, Oldgren J, Siegbahn A, Stewart RA, White HD, Granger CB, Wallentin L; ARISTOTLE and STABILITY Investigators. The ABC (age, biomarkers, clinical history) stroke risk score: a biomarker-based risk score for predicting stroke in atrial fibrillation. Eur Heart J. 2016 May 21;37(20):1582-90. doi: 10.1093/eurheartj/ehw054. Epub 2016 Feb 25.
Hijazi Z, Aulin J, Andersson U, Alexander JH, Gersh B, Granger CB, Hanna M, Horowitz J, Hylek EM, Lopes RD, Siegbahn A, Wallentin L; ARISTOTLE Investigators. Biomarkers of inflammation and risk of cardiovascular events in anticoagulated patients with atrial fibrillation. Heart. 2016 Apr;102(7):508-17. doi: 10.1136/heartjnl-2015-308887. Epub 2016 Feb 2.
Rao MP, Halvorsen S, Wojdyla D, Thomas L, Alexander JH, Hylek EM, Hanna M, Bahit MC, Lopes RD, De Caterina R, Erol C, Goto S, Lanas F, Lewis BS, Husted S, Gersh BJ, Wallentin L, Granger CB; Apixaban for Reduction in Stroke and Other Thromboembolic Events in Atrial Fibrillation (ARISTOTLE) Steering Committee and Investigators. Blood Pressure Control and Risk of Stroke or Systemic Embolism in Patients With Atrial Fibrillation: Results From the Apixaban for Reduction in Stroke and Other Thromboembolic Events in Atrial Fibrillation (ARISTOTLE) Trial. J Am Heart Assoc. 2015 Dec 1;4(12):e002015. doi: 10.1161/JAHA.115.002015. Erratum In: J Am Heart Assoc. 2021 Feb 16;10(4):e014653. doi: 10.1161/JAHA.119.014653.
Vinereanu D, Stevens SR, Alexander JH, Al-Khatib SM, Avezum A, Bahit MC, Granger CB, Lopes RD, Halvorsen S, Hanna M, Husted S, Hylek EM, Margulescu AD, Wallentin L, Atar D. Clinical outcomes in patients with atrial fibrillation according to sex during anticoagulation with apixaban or warfarin: a secondary analysis of a randomized controlled trial. Eur Heart J. 2015 Dec 7;36(46):3268-75. doi: 10.1093/eurheartj/ehv447. Epub 2015 Sep 14.
Avezum A, Lopes RD, Schulte PJ, Lanas F, Gersh BJ, Hanna M, Pais P, Erol C, Diaz R, Bahit MC, Bartunek J, De Caterina R, Goto S, Ruzyllo W, Zhu J, Granger CB, Alexander JH. Apixaban in Comparison With Warfarin in Patients With Atrial Fibrillation and Valvular Heart Disease: Findings From the Apixaban for Reduction in Stroke and Other Thromboembolic Events in Atrial Fibrillation (ARISTOTLE) Trial. Circulation. 2015 Aug 25;132(8):624-32. doi: 10.1161/CIRCULATIONAHA.114.014807. Epub 2015 Jun 23.
Held C, Hylek EM, Alexander JH, Hanna M, Lopes RD, Wojdyla DM, Thomas L, Al-Khalidi H, Alings M, Xavier D, Ansell J, Goto S, Ruzyllo W, Rosenqvist M, Verheugt FW, Zhu J, Granger CB, Wallentin L. Clinical outcomes and management associated with major bleeding in patients with atrial fibrillation treated with apixaban or warfarin: insights from the ARISTOTLE trial. Eur Heart J. 2015 May 21;36(20):1264-72. doi: 10.1093/eurheartj/ehu463. Epub 2014 Dec 12.
Hijazi Z, Siegbahn A, Andersson U, Lindahl B, Granger CB, Alexander JH, Atar D, Gersh BJ, Hanna M, Harjola VP, Horowitz J, Husted S, Hylek EM, Lopes RD, McMurray JJ, Wallentin L. Comparison of cardiac troponins I and T measured with high-sensitivity methods for evaluation of prognosis in atrial fibrillation: an ARISTOTLE substudy. Clin Chem. 2015 Feb;61(2):368-78. doi: 10.1373/clinchem.2014.226936. Epub 2014 Dec 1.
Garcia D, Alexander JH, Wallentin L, Wojdyla DM, Thomas L, Hanna M, Al-Khatib SM, Dorian P, Ansell J, Commerford P, Flaker G, Lanas F, Vinereanu D, Xavier D, Hylek EM, Held C, Verheugt FW, Granger CB, Lopes RD. Management and clinical outcomes in patients treated with apixaban vs warfarin undergoing procedures. Blood. 2014 Dec 11;124(25):3692-8. doi: 10.1182/blood-2014-08-595496. Epub 2014 Oct 15.
Wallentin L, Hijazi Z, Andersson U, Alexander JH, De Caterina R, Hanna M, Horowitz JD, Hylek EM, Lopes RD, Asberg S, Granger CB, Siegbahn A; ARISTOTLE Investigators. Growth differentiation factor 15, a marker of oxidative stress and inflammation, for risk assessment in patients with atrial fibrillation: insights from the Apixaban for Reduction in Stroke and Other Thromboembolic Events in Atrial Fibrillation (ARISTOTLE) trial. Circulation. 2014 Nov 18;130(21):1847-58. doi: 10.1161/CIRCULATIONAHA.114.011204. Epub 2014 Oct 7.
Hijazi Z, Siegbahn A, Andersson U, Granger CB, Alexander JH, Atar D, Gersh BJ, Mohan P, Harjola VP, Horowitz J, Husted S, Hylek EM, Lopes RD, McMurray JJ, Wallentin L; ARISTOTLE Investigators. High-sensitivity troponin I for risk assessment in patients with atrial fibrillation: insights from the Apixaban for Reduction in Stroke and other Thromboembolic Events in Atrial Fibrillation (ARISTOTLE) trial. Circulation. 2014 Feb 11;129(6):625-34. doi: 10.1161/CIRCULATIONAHA.113.006286. Epub 2013 Nov 13.
Flaker G, Lopes RD, Al-Khatib SM, Hermosillo AG, Hohnloser SH, Tinga B, Zhu J, Mohan P, Garcia D, Bartunek J, Vinereanu D, Husted S, Harjola VP, Rosenqvist M, Alexander JH, Granger CB; ARISTOTLE Committees and Investigators. Efficacy and safety of apixaban in patients after cardioversion for atrial fibrillation: insights from the ARISTOTLE Trial (Apixaban for Reduction in Stroke and Other Thromboembolic Events in Atrial Fibrillation). J Am Coll Cardiol. 2014 Mar 25;63(11):1082-7. doi: 10.1016/j.jacc.2013.09.062. Epub 2013 Nov 6.
Hijazi Z, Wallentin L, Siegbahn A, Andersson U, Alexander JH, Atar D, Gersh BJ, Hanna M, Harjola VP, Horowitz JD, Husted S, Hylek EM, Lopes RD, McMurray JJ, Granger CB; ARISTOTLE Investigators. High-sensitivity troponin T and risk stratification in patients with atrial fibrillation during treatment with apixaban or warfarin. J Am Coll Cardiol. 2014 Jan 7-14;63(1):52-61. doi: 10.1016/j.jacc.2013.07.093. Epub 2013 Sep 19.
Alexander JH, Levy E, Lawrence J, Hanna M, Waclawski AP, Wang J, Califf RM, Wallentin L, Granger CB. Documentation of study medication dispensing in a prospective large randomized clinical trial: experiences from the ARISTOTLE Trial. Am Heart J. 2013 Sep;166(3):559-65. doi: 10.1016/j.ahj.2013.05.025. Epub 2013 Aug 15.
Garcia DA, Wallentin L, Lopes RD, Thomas L, Alexander JH, Hylek EM, Ansell J, Hanna M, Lanas F, Flaker G, Commerford P, Xavier D, Vinereanu D, Yang H, Granger CB. Apixaban versus warfarin in patients with atrial fibrillation according to prior warfarin use: results from the Apixaban for Reduction in Stroke and Other Thromboembolic Events in Atrial Fibrillation trial. Am Heart J. 2013 Sep;166(3):549-58. doi: 10.1016/j.ahj.2013.05.016. Epub 2013 Jul 25.
Wallentin L, Lopes RD, Hanna M, Thomas L, Hellkamp A, Nepal S, Hylek EM, Al-Khatib SM, Alexander JH, Alings M, Amerena J, Ansell J, Aylward P, Bartunek J, Commerford P, De Caterina R, Erol C, Harjola VP, Held C, Horowitz JD, Huber K, Husted S, Keltai M, Lanas F, Lisheng L, McMurray JJ, Oh BH, Rosenqvist M, Ruzyllo W, Steg PG, Vinereanu D, Xavier D, Granger CB; Apixaban for Reduction in Stroke and Other Thromboembolic Events in Atrial Fibrillation (ARISTOTLE) Investigators. Efficacy and safety of apixaban compared with warfarin at different levels of predicted international normalized ratio control for stroke prevention in atrial fibrillation. Circulation. 2013 Jun 4;127(22):2166-76. doi: 10.1161/CIRCULATIONAHA.112.142158. Epub 2013 May 2.
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Public notes

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Bristol-Myers Squibb
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Bristol-Myers Squibb
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Summary Results

For IPD and results data, please see https://clinicaltrials.gov/study/NCT00412984