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Related trials

ENGAGE-AF TIMI 48 Low dose, 2013 - edoxaban low dose vs warfarin

ENGAGE-AF TIMI 48 High dose, 2013 - edoxaban high dose vs warfarin standard dose

AVERROES, 2011 - apixaban vs aspirin

ARISTOTLE, 2011 - apixaban vs warfarin standard dose

ROCKET-AF, 2010 - rivaroxaban vs warfarin standard dose

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

ACTIVE A, 2009 - aspirin + clopidogrel vs aspirin

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

RE-LY (110mg), 2009 - dabigatran 110mg 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+coumadin medium dose vs triflusal), 2004 - triflusal+coumadin medium dose vs triflusal

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

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



See also:

  • All atrial fibrillation clinical trials
  • All clinical trials of direct oral anticoagulant (DAO)
  • All clinical trials of edoxaban high dose
  •  
     ENGAGE-AF TIMI 48 High dose study, 2013 TRC9825 
    [NCT00781391] download pdf: edoxaban high dose | antithrombotics for atrial fibrillation

    Treatments

    Studied treatment edoxaban 60mg once daily
    Control treatment warfarin (INR 2-3)
    Remarks a third arm received a low dose of edoxaban, 30mg. The allocated dose was halved if any of the following characteristics were present at the time of randomization or during the study: estimated creatinine clearance of 30 to 50 ml per minute, a body weight of 60 kg or less, or the concomitant use of verapamil or quinidine (potent P-glycoprotein inhibitors)

    Patients

    Patients AF patients (CHADS2 >=2)
    Inclusion criteria documented AF within the prior 12 months; moderate to high risk of stroke, as defined by CHADS2 index score of at least 2
    Exclusion criteria Transient atrial fibrillation secondary to other reversible disorders; moderate or severe mitral stenosis, unresected atrial myxoma, or a mechanical heart valve; contraindication for anticoagulant agents; conditions associated with high risk of bleeding; known or suspected hereditary or acquired bleeding disorders

    Method and design

    Randomized effectives 7035 / 7036 (studied vs. control)
    Design Parallel groups
    Blinding double blind
    Follow-up duration 2.8 years
    Number of centre 1393
    Geographic area 46 countries
    Primary endpoint stroke, systemic embolic events and all-cause mortality


    Results

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

    thrombo-embolic event (cerebral or systemic)

    NA / 7035
    NA / 7036
    0,87 [0,73;1,04]

    systemic thrombo-embolic complication

    NA / 7035
    NA / 7036
    0,65 [0,34;1,24]

    stroke (fatal and non fatal)

    NA / 7035
    NA / 7036
    0,88 [0,75;1,03]

    ischemic stroke

    NA / 7035
    NA / 7036
    1,00 [0,84;1,20]

    myocardial infarction (fatal and non fatal)

    NA / 7035
    NA / 7036
    0,94 [0,74;1,19]

    All cause death

    NA / 7035
    NA / 7036
    0,92 [0,83;1,01]

    Bleeding

    NA / 7035
    NA / 7036
    0,87 [0,82;0,92]

    Major bleeding

    NA / 7035
    NA / 7036
    0,80 [0,71;0,91]

    Minor bleeding

    NA / 7035
    NA / 7036
    0,84 [0,76;0,93]

    Haemmorhagic stroke

    NA / 7035
    NA / 7036
    0,47 [0,35;0,64]

    Fatal bleeding

    NA / 7035
    NA / 7036
    0,55 [0,36;0,84]

    Gastrointestinal major bleeding

    NA / 7035
    NA / 7036
    1,23 [1,01;1,49]

    major or clinically relevant non-major bleeding

    NA / 7035
    NA / 7036
    0,86 [0,80;0,92]

    Cardiovascular death

    NA / 7035
    NA / 7036
    0,86 [0,77;0,97]

    Fatal stroke

    NA / 7035
    NA / 7036
    0,92 [0,68;1,25]

    Lifethreatening major bleeding

    NA / 7035
    NA / 7036
    0,51 [0,38;0,69]

    intracranial hemorrhage

    NA / 7035
    NA / 7036
    0,47 [0,35;0,64]
    0 2 1.0

    Relative risks
    Endpoint Events (%) Relative Risk 95% CI Endpoint definition
    in the trial
    Ref
    Studied treat. Control treat.
    thrombo-embolic event (cerebral or systemic) NA / 7035 NA / 7036 0,87 [0,73;1,04] Intention-to-treat population in the overall study period   
    systemic thrombo-embolic complication NA / 7035 NA / 7036 0,65 [0,34;1,24]    
    stroke (fatal and non fatal) NA / 7035 NA / 7036 0,88 [0,75;1,03]    
    ischemic stroke NA / 7035 NA / 7036 1,00 [0,84;1,20] 1.00 (0.83–1.19)   
    myocardial infarction (fatal and non fatal) NA / 7035 NA / 7036 0,94 [0,74;1,19]    
    All cause death NA / 7035 NA / 7036 0,92 [0,83;1,01]    
    Bleeding NA / 7035 NA / 7036 0,87 [0,82;0,92]    
    Major bleeding NA / 7035 NA / 7036 0,80 [0,71;0,91]    
    Minor bleeding NA / 7035 NA / 7036 0,84 [0,76;0,93]    
    Haemmorhagic stroke NA / 7035 NA / 7036 0,47 [0,35;0,64]    
    Fatal bleeding NA / 7035 NA / 7036 0,55 [0,36;0,84]    
    Gastrointestinal major bleeding NA / 7035 NA / 7036 1,23 [1,01;1,49]    
    major or clinically relevant non-major bleeding NA / 7035 NA / 7036 0,86 [0,80;0,92]    
    Cardiovascular death NA / 7035 NA / 7036 0,86 [0,77;0,97]    
    Fatal stroke NA / 7035 NA / 7036 0,92 [0,68;1,25]    
    Lifethreatening major bleeding NA / 7035 NA / 7036 0,51 [0,38;0,69]    
    intracranial hemorrhage NA / 7035 NA / 7036 0,47 [0,35;0,64]    
    The primary endpoint (if exists) appears in blod characters
    Reference(s) used for data extraction:

    Endpoint studied treat. control treat. mean diff

    Absolute risk reduction (for a follow-up of 2.8 years)
    Endpoint Events rate Absolute risk
    reduction (ARR)
    Studied treat. Control treat.

    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

    direct oral anticoagulant (DAO) in atrial fibrillation for all type of patients



    Reference(s)

    TrialResults-center ID TRC9825
    Trials register # NCT00781391
    • Ruff CT, Giugliano RP, Antman EM, Crugnale SE, Bocanegra T, Mercuri M, Hanyok J, Patel I, Shi M, Salazar D, McCabe CH, Braunwald E. Evaluation of the novel factor Xa inhibitor edoxaban compared with warfarin in patients with atrial fibrillation: design and rationale for the Effective aNticoaGulation with factor xA next GEneration in Atrial Fibrillation-Thrombolysis In Myocardial Infarction study 48 (ENGAGE AF-TIMI 48).. Am Heart J 2010;160:635-41 - 10.1016/j.ahj.2010.06.042
      Pubmed | Hubmed | Fulltext
    • Giugliano RP, Ruff CT, Braunwald E, Murphy SA, Wiviott SD, Halperin JL, Waldo AL, Ezekowitz MD, Weitz JI, Špinar J, Ruzyllo W, Ruda M, Koretsune Y, Betcher J, Shi M, Grip LT, Patel SP, Patel I, Hanyok JJ, Mercuri M, Antman EM. Edoxaban versus warfarin in patients with atrial fibrillation.. N Engl J Med 2013 Nov 28;369:2093-104
      Pubmed | Hubmed | Fulltext

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