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Related trials

AVERROES, 2011 - apixaban vs aspirin

ARISTOTLE, 2011 - apixaban vs warfarin standard dose

ROCKET-AF, 2010 - rivaroxaban vs warfarin standard dose

RE-LY (110mg), 2009 - dabigatran 110mg vs warfarin standard dose

ACTIVE A, 2009 - aspirin + clopidogrel vs aspirin

Lip (phase 2 AZD0837), 2009 - AZD0837 vs warfarin standard dose

RE-LY (150mg), 2009 - dabigatran 150mg vs warfarin standard dose

AMADEUS, 2008 - idraparinux vs warfarin standard dose

PETRO (150mg), 2007 - dabigatran 150mg vs warfarin standard dose

ACTIVE W, 2006 - aspirin + clopidogrel vs anticoagulant

Japanese AF Trial, 2006 - aspirin vs control

SPORTIF V, 2005 - ximelagatran vs warfarin standard dose

NASPEAF (triflusal vs coumadin standard dose)), 2004 - triflusal vs coumadin standard dose

NASPEAF (triflusal + coumadin medium dose vs coumadin standard dose), 2004 - triflusal+coumadin medium dose vs coumadin standard dose

NASPEAF (triflusal+coumadin medium dose vs triflusal), 2004 - triflusal+coumadin medium dose vs triflusal

SAFT(warfarin low dose + aspirin vs no treatment), 2003 - warfarin low dose + aspirin vs control

SPORTIF III, 2003 - ximelagatran vs warfarin standard dose

SPORTIF II (ximelagatran vs warfarin standard dose), 2002 - ximelagatran vs warfarin standard dose

PATAF (vs coumadin low dose), 1999 - aspirin vs coumadin low dose

PATAF (coumadin low dose vs coumadin standard dose), 1999 - coumadin low dose vs coumadin standard dose

PATAF (vs coumadin standard dose), 1999 - aspirin vs coumadin standard dose

LASAF(aspirin vs no treatment), 1999 - aspirin vs control

AFASAK II (aspirin vs warfarin standard dose), 1998 - aspirin vs warfarin standard dose

MWNAF, 1998 - warfarin low dose vs warfarin standard dose

AFASAK II (warfarin low dose vs warfarin standard dose), 1998 - warfarin low dose vs warfarin standard dose



See also:

  • All atrial fibrillation clinical trials
  • All clinical trials of new oral anticoagulants
  • All clinical trials of apixaban
  •  

    ARISTOTLE study, 2011

    [NCT00412984] download pdf: apixaban | antithrombotics for atrial fibrillation

    Treatments

    Studied treatment apixaban 5mg twice daily
    Control treatment warfarin adjusted for an INR between 2 and 3
    Treatments description
    time within the therapeutic range (%) mean 62% (median 66%) 

    Patients

    Patients subjects with atrial fibrillation and risk factors for stroke
    Inclusion criteria males and females >= 18 yrs with AF and one or more of the following risk factors for stroke: age ¡Ý 75, previous stroke TIA or Systemic Embolism Symptomatic congestive heart failure or left ventricular dysfunction with LVEF <=40% Diabetes mellitus or hypertension requiring pharmacological treatment
    Baseline characteristics
    age(mean) 70 yrs (median) 
    male(%) 65% 
    weight(mean) 82 kg (median) 
    systolic blood pressure(mean) 130 mmHg (median) 
    hypertension(%) 87.5% 
    diabete mellitus(%) 25% 
    prior TIA or stroke(%) 19.45% 
    left ventricular dysfunction(%) 35.5% 
    prior myocardial infarction(%) 14.2% 
    paroxysmal AF(%) 15.3% 
    subgroup test
    CHADS2 Score (mean) 2.1 
    CHADS2 Score = 2 (%) 35.8% 
    CHADS2 Score = 3 (%) 30.2% 

    Method and design

    Randomized effectives 9120 / 9081 (studied vs. control)
    Design Parallel groups
    Blinding double blind
    Follow-up duration 1.8 yrs (median)
    Number of centre 1034
    Geographic area 39 countries
    Hypothesis Non inferiority
    Primary endpoint stroke or systemic embolism
    Remarks

    Remarks / Comments



    Results

    Endpoint Studied treat.
    n/N
    Control treat.
    n/N
    Graph RR [95% CI]

    Coronary event

    90 / 9088
    102 / 9052
    0,88 [0,66;1,17]

    thrombo-embolic event (cerebral or systemic)

    212 / 9120
    265 / 9081
    0,80 [0,67;0,95]

    systemic thrombo-embolic complication

    15 / 9120
    17 / 9081
    0,88 [0,44;1,76]

    stroke (fatal and non fatal)

    199 / 9120
    250 / 9081
    0,79 [0,66;0,95]

    ischemic stroke

    162 / 9120
    175 / 9081
    0,92 [0,75;1,14]

    myocardial infarction (fatal and non fatal)

    90 / 9120
    102 / 9081
    0,88 [0,66;1,16]

    All cause death

    603 / 9120
    669 / 9081
    0,90 [0,81;1,00]

    Bleeding

    2356 / 9120
    3060 / 9081
    0,77 [0,73;0,80]

    Major bleeding

    327 / 9120
    462 / 9081
    0,70 [0,61;0,81]

    Haemmorhagic stroke

    40 / 9120
    78 / 9081
    0,51 [0,35;0,75]

    Gastrointestinal major bleeding

    105 / 9120
    119 / 9081
    0,88 [0,68;1,14]

    major or clinically relevant non-major bleeding

    613 / 9120
    877 / 9081
    0,70 [0,63;0,77]

    intracranial hemorrhage

    52 / 9120
    122 / 9081
    0,42 [0,31;0,59]
    0 2 1.0

    Relative risks
    Endpoint Events (%) Relative Risk 95% CI Endpoint definition
    in the trial
    Ref
    Studied treat. Control treat.
    Coronary event 90 / 9088 (1,0%) 102 / 9052 (1,1%) 0,88 [0,66;1,17]   16949
    thrombo-embolic event (cerebral or systemic) 212 / 9120 (2,3%) 265 / 9081 (2,9%) 0,80 [0,67;0,95] ITT population  14873
    systemic thrombo-embolic complication 15 / 9120 (0,2%) 17 / 9081 (0,2%) 0,88 [0,44;1,76]   14873
    stroke (fatal and non fatal) 199 / 9120 (2,2%) 250 / 9081 (2,8%) 0,79 [0,66;0,95]   14873
    ischemic stroke 162 / 9120 (1,8%) 175 / 9081 (1,9%) 0,92 [0,75;1,14] Ischemic or uncertain type of stroke  14873
    myocardial infarction (fatal and non fatal) 90 / 9120 (1,0%) 102 / 9081 (1,1%) 0,88 [0,66;1,16]   14873
    All cause death 603 / 9120 (6,6%) 669 / 9081 (7,4%) 0,90 [0,81;1,00]   14873
    Bleeding 2356 / 9120 (25,8%) 3060 / 9081 (33,7%) 0,77 [0,73;0,80]   14873
    Major bleeding 327 / 9120 (3,6%) 462 / 9081 (5,1%) 0,70 [0,61;0,81] ISTH major bleeding  14873
    Haemmorhagic stroke 40 / 9120 (0,4%) 78 / 9081 (0,9%) 0,51 [0,35;0,75] Hemorrhagic stroke  14873
    Gastrointestinal major bleeding 105 / 9120 (1,2%) 119 / 9081 (1,3%) 0,88 [0,68;1,14]   14873
    major or clinically relevant non-major bleeding 613 / 9120 (6,7%) 877 / 9081 (9,7%) 0,70 [0,63;0,77]   14873
    intracranial hemorrhage 52 / 9120 (0,6%) 122 / 9081 (1,3%) 0,42 [0,31;0,59] ISTH major bleeding  14873
    The primary endpoint (if exists) appears in blod characters
    Reference(s) used for data extraction:
  • 14873: Granger CB, Alexander JH, McMurray JJ, Lopes RD, Hylek EM, Hanna M, Al-Khalidi HR, Ansell J, Atar D, Avezum A, Bahit MC, Diaz R, Easton JD, Ezekowitz JA, Flaker G, Garcia D, Geraldes M, Gersh BJ, Golitsyn S, Goto S, Hermosillo AG, Hohnloser SH, Horowitz JApixaban versus Warfarin in Patients with Atrial Fibrillation.N Engl J Med 2011 Aug 27;:
  • 16949: Mak KHCoronary and mortality risk of novel oral antithrombotic agents: a meta-analysis of large randomised trials.BMJ Open 2012;2:

  • Endpoint studied treat. control treat. mean diff

    Absolute risk reduction
    Endpoint Events rate Absolute risk
    reduction (ARR)
    Studied treat. Control treat.
    Coronary event 9,90‰ 1,13% -1,4‰
    thrombo-embolic event (cerebral or systemic) 2,32% 2,92% -5,9‰
    systemic thrombo-embolic complication 1,64‰ 1,87‰ -0,2‰
    stroke (fatal and non fatal) 2,18% 2,75% -5,7‰
    ischemic stroke 1,78% 1,93% -1,5‰
    myocardial infarction (fatal and non fatal) 9,87‰ 1,12% -1,4‰
    All cause death 6,61% 7,37% -7,6‰
    Bleeding 25,83% 33,70% -78,6‰
    Major bleeding 3,59% 5,09% -15,0‰
    Haemmorhagic stroke 4,39‰ 8,59‰ -4,2‰
    Gastrointestinal major bleeding 1,15% 1,31% -1,6‰
    major or clinically relevant non-major bleeding 6,72% 9,66% -29,4‰
    intracranial hemorrhage 5,70‰ 1,34% -7,7‰

    Meta-analysis of all similar trials:

    antithrombotics in atrial fibrillation for primary prevention of thromboembolic events

    direct factor Xa inhibitors in atrial fibrillation for all type of patients

    new oral anticoagulants in atrial fibrillation for all type of patients



    Reference(s)

    Trials register # NCT00412984
    • Lopes RD, Alexander JH, Al-Khatib SM, Ansell J, Diaz R, Easton JD, Gersh BJ, Granger CB, Hanna M, Horowitz J, Hylek EM, McMurray JJ, Verheugt FW, Wallentin L. Apixaban for reduction in stroke and other ThromboemboLic events in atrial fibrillation (ARISTOTLE) trial: design and rationale.. Am Heart J 2010;159:331-9 - 10.1016/j.ahj.2009.07.035
      Pubmed | Hubmed | Fulltext
    • Granger CB, Alexander JH, McMurray JJ, Lopes RD, Hylek EM, Hanna M, Al-Khalidi HR, Ansell J, Atar D, Avezum A, Bahit MC, Diaz R, Easton JD, Ezekowitz JA, Flaker G, Garcia D, Geraldes M, Gersh BJ, Golitsyn S, Goto S, Hermosillo AG, Hohnloser SH, Horowitz J. Apixaban versus Warfarin in Patients with Atrial Fibrillation.. N Engl J Med 2011 Aug 27;: - 10.1056/NEJMoa1107039
      Pubmed | Hubmed | Fulltext

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