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See also:

  • All atrial fibrillation clinical trials
  • All clinical trials of new oral anticoagulants
  • All clinical trials of dabigatran 110mg
  •  
     RE-LY (110mg) study, 2009 TRC9892 
    [NCT00262600] download pdf: dabigatran 110mg | antithrombotics for atrial fibrillation

    Treatments

    Studied treatment dabigatran 110 mg twice a day
    Control treatment warfarin adjusted dose to a 2-3 INR
    Remarks 3 arms: dabigatran 110 mg, 150mg and warfarin
    Treatments description
    time within the therapeutic range (%) 64% mean 

    Patients

    Patients Patients With Non-Valvular Atrial Fibrillation
    Inclusion criteria Patients with non-valvular atrial fibrillation (AF), at moderate to high risk of stroke, or systemic embolism with at least one additional risk factor (i.e. pre vious ischemic stroke, TIA, or systemic embolism, left ventricular dysfunction, age >=75 years, age >=65 with either diabetes mellitus, history of coronary artery disease or hy pertension)
    Baseline characteristics
    age(mean) 71.5y 
    male(%) 63.3% 
    weight(mean) 82.6 kg 
    systolic blood pressure(mean) 131.1 mm Hg 
    diastolic blood pressure(mean) 77 mmHg 
    hypertension(%) 78.9% 
    diabete mellitus(%) 23.2% 
    prior TIA or stroke(%) 20% 
    prior myocardial infarction(%) 16.5% 
    paroxysmal AF(%) 33.2% 
    subgroup test

    Method and design

    Randomized effectives 6015 / 6022 (studied vs. control)
    Design Parallel groups
    Blinding open (blind assessment)
    Follow-up duration 2 y (median)
    Number of centre 951
    Geographic area 44 countries
    Hypothesis Non inferiority
    Primary endpoint stroke or systemic embolism
    Remarks

    Remarks / Comments



    Results



    Endpoints and data reported in the trial's publication(s)

    Endpoint Events (%) Relative Risk 95% CI
    Studied treat. Control treat.
    Stroke or systemic embolism 182 / 6015 (3,0%) 199 / 6022 (3,3%) 0,92 [0,75;1,12]
    Stroke 171 / 6015 (2,8%) 185 / 6022 (3,1%) 0,93 [0,75;1,14]
    Hemorrhagic Stroke 14 / 6015 (0,2%) 45 / 6022 (0,7%) 0,31 [0,17;0,57]
    Ischemic or unspecified stroke 159 / 6015 (2,6%) 142 / 6022 (2,4%) 1,12 [0,90;1,40]
    Nondisabling stroke 60 / 6015 (1,0%) 69 / 6022 (1,1%) 0,87 [0,62;1,23]
    Disabling or fatal stroke 112 / 6015 (1,9%) 118 / 6022 (2,0%) 0,95 [0,74;1,23]
    Myocardial infarction 86 / 6015 (1,4%) 63 / 6022 (1,0%) 1,37 [0,99;1,89]
    Pulmonary embolism 14 / 6015 (0,2%) 11 / 6022 (0,2%) 1,27 [0,58;2,80]
    Hospitalization 2311 / 6015 (38,4%) 2458 / 6022 (40,8%) 0,94 [0,90;0,98]
    Death from vascular causes 289 / 6015 (4,8%) 317 / 6022 (5,3%) 0,91 [0,78;1,07]
    Death from any cause 446 / 6015 (7,4%) 487 / 6022 (8,1%) 0,92 [0,81;1,04]
    Major bleeding 322 / 6015 (5,4%) 397 / 6022 (6,6%) 0,81 [0,70;0,94]
    Life threatening Major bleeding 145 / 6015 (2,4%) 212 / 6022 (3,5%) 0,68 [0,56;0,84]
    Non–life threatening Major bleeding 198 / 6015 (3,3%) 208 / 6022 (3,5%) 0,95 [0,79;1,15]
    Gastrointestinal Major bleeding 133 / 6015 (2,2%) 120 / 6022 (2,0%) 1,11 [0,87;1,42]
    Minor bleeding 1566 / 6015 (26,0%) 1931 / 6022 (32,1%) 0,81 [0,77;0,86]
    Major or minor bleeding 1740 / 6015 (28,9%) 2142 / 6022 (35,6%) 0,81 [0,77;0,86]
    Intracranial bleeding 27 / 6015 (0,4%) 87 / 6022 (1,4%) 0,31 [0,20;0,48]
    Extracranial bleeding 299 / 6015 (5,0%) 315 / 6022 (5,2%) 0,95 [0,81;1,11]
    Net clinical benefit 844 / 6015 (14,0%) 901 / 6022 (15,0%) 0,94 [0,86;1,02]

    Endpoints used by the meta-analysis and data retained for this trial

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

    thrombo-embolic event (cerebral or systemic)

    182 / 6015
    199 / 6022
    0,92 [0,75;1,12]

    systemic thrombo-embolic complication

    11 / 6015
    14 / 6022
    0,79 [0,36;1,73]

    stroke (fatal and non fatal)

    171 / 6015
    185 / 6022
    0,93 [0,75;1,14]

    ischemic stroke

    159 / 6015
    142 / 6022
    1,12 [0,90;1,40]

    myocardial infarction (fatal and non fatal)

    86 / 6015
    63 / 6022
    1,37 [0,99;1,89]

    All cause death

    446 / 6015
    487 / 6022
    0,92 [0,81;1,04]

    Bleeding

    1740 / 6015
    2142 / 6022
    0,81 [0,77;0,86]

    Major bleeding

    322 / 6015
    397 / 6022
    0,81 [0,70;0,94]

    Minor bleeding

    1566 / 6015
    1931 / 6022
    0,81 [0,77;0,86]

    Haemmorhagic stroke

    14 / 6015
    45 / 6022
    0,31 [0,17;0,57]

    Gastrointestinal major bleeding

    133 / 6015
    120 / 6022
    1,11 [0,87;1,42]

    Cardiovascular death

    289 / 6015
    317 / 6022
    0,91 [0,78;1,07]

    Fatal stroke

    112 / 6015
    118 / 6022
    0,95 [0,74;1,23]

    Non-lifethreatening major bleeding

    198 / 6015
    208 / 6022
    0,95 [0,79;1,15]

    Lifethreatening major bleeding

    145 / 6015
    212 / 6022
    0,68 [0,56;0,84]

    TE event or ischemic stroke or systemic embolism

    182 / 6015
    199 / 6022
    0,92 [0,75;1,12]

    Non fatal stroke

    60 / 6015
    69 / 6022
    0,87 [0,62;1,23]

    intracranial hemorrhage

    27 / 6015
    87 / 6022
    0,31 [0,20;0,48]
    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) 182 / 6015 (3,0%) 199 / 6022 (3,3%) 0,92 [0,75;1,12] Stroke or systemic embolism 
    systemic thrombo-embolic complication 11 / 6015 (0,2%) 14 / 6022 (0,2%) 0,79 [0,36;1,73] imputed  11171
    stroke (fatal and non fatal) 171 / 6015 (2,8%) 185 / 6022 (3,1%) 0,93 [0,75;1,14] Stroke 
    ischemic stroke 159 / 6015 (2,6%) 142 / 6022 (2,4%) 1,12 [0,90;1,40] Ischemic or unspecified stroke 
    myocardial infarction (fatal and non fatal) 86 / 6015 (1,4%) 63 / 6022 (1,0%) 1,37 [0,99;1,89] Myocardial infarction 
    All cause death 446 / 6015 (7,4%) 487 / 6022 (8,1%) 0,92 [0,81;1,04] Death from any cause 
    Bleeding 1740 / 6015 (28,9%) 2142 / 6022 (35,6%) 0,81 [0,77;0,86] Major or minor bleeding 
    Major bleeding 322 / 6015 (5,4%) 397 / 6022 (6,6%) 0,81 [0,70;0,94] Major bleeding 
    Minor bleeding 1566 / 6015 (26,0%) 1931 / 6022 (32,1%) 0,81 [0,77;0,86] Minor bleeding 
    Haemmorhagic stroke 14 / 6015 (0,2%) 45 / 6022 (0,7%) 0,31 [0,17;0,57] Hemorrhagic Stroke  
    Gastrointestinal major bleeding 133 / 6015 (2,2%) 120 / 6022 (2,0%) 1,11 [0,87;1,42] Gastrointestinal Major bleeding  
    Cardiovascular death 289 / 6015 (4,8%) 317 / 6022 (5,3%) 0,91 [0,78;1,07] Death from vascular causes 
    Fatal stroke 112 / 6015 (1,9%) 118 / 6022 (2,0%) 0,95 [0,74;1,23] Disabling or fatal stroke 
    Non-lifethreatening major bleeding 198 / 6015 (3,3%) 208 / 6022 (3,5%) 0,95 [0,79;1,15] Non–life threatening Major bleeding  
    Lifethreatening major bleeding 145 / 6015 (2,4%) 212 / 6022 (3,5%) 0,68 [0,56;0,84] Life threatening Major bleeding  
    TE event or ischemic stroke or systemic embolism 182 / 6015 (3,0%) 199 / 6022 (3,3%) 0,92 [0,75;1,12] Stroke or systemic embolism 
    Non fatal stroke 60 / 6015 (1,0%) 69 / 6022 (1,1%) 0,87 [0,62;1,23] Nondisabling stroke 
    intracranial hemorrhage 27 / 6015 (0,4%) 87 / 6022 (1,4%) 0,31 [0,20;0,48] Intracranial bleeding 
    The primary endpoint (if exists) appears in blod characters
    Reference(s) used for data extraction:
  • 11171: Connolly SJ, Ezekowitz MD, Yusuf S, Eikelboom J, Oldgren J, Parekh A, Pogue J, Reilly PA, Themeles E, Varrone J, Wang S, Alings M, Xavier D, Zhu J, Diaz R, Lewis BS, Darius H, Diener HC, Joyner CD, Wallentin LDabigatran versus Warfarin in Patients with Atrial Fibrillation.N Engl J Med 2009 Aug 30;:
  • 0:

  • Endpoint studied treat. control treat. mean diff

    Absolute risk reduction (for a follow-up of 2 y (median))
    Endpoint Events rate Absolute risk
    reduction (ARR)
    Studied treat. Control treat.
    thrombo-embolic event (cerebral or systemic) 3,03% 3,30% -0,28%
    systemic thrombo-embolic complication 1,83‰ 2,32‰ -0,05%
    stroke (fatal and non fatal) 2,84% 3,07% -0,23%
    ischemic stroke 2,64% 2,36% 0,29%
    myocardial infarction (fatal and non fatal) 1,43% 1,05% 0,38%
    All cause death 7,41% 8,09% -0,67%
    Bleeding 28,93% 35,57% -6,64%
    Major bleeding 5,35% 6,59% -1,24%
    Minor bleeding 26,03% 32,07% -6,03%
    Haemmorhagic stroke 2,33‰ 7,47‰ -0,51%
    Gastrointestinal major bleeding 2,21% 1,99% 0,22%
    Cardiovascular death 4,80% 5,26% -0,46%
    Fatal stroke 1,86% 1,96% -0,10%
    Non-lifethreatening major bleeding 3,29% 3,45% -0,16%
    Lifethreatening major bleeding 2,41% 3,52% -1,11%
    TE event or ischemic stroke or systemic embolism 3,03% 3,30% -0,28%
    Non fatal stroke 9,98‰ 1,15% -0,15%
    intracranial hemorrhage 4,49‰ 1,44% -1,00%

    Meta-analysis of all similar trials:

    antithrombotics in atrial fibrillation for primary prevention of thromboembolic events

    direct antithrombins in atrial fibrillation for all type of patients

    new oral anticoagulants in atrial fibrillation for all type of patients



    Reference(s)

    TrialResults-center ID TRC9892
    Trials register # NCT00262600
    • Ezekowitz MD, Connolly S, Parekh A, Reilly PA, Varrone J, Wang S, Oldgren J, Themeles E, Wallentin L, Yusuf S. . Am Heart J 2009;157:805-10, 810.e1-2
      Pubmed | Hubmed | Fulltext
    • Connolly SJ, Ezekowitz MD, Yusuf S, Eikelboom J, Oldgren J, Parekh A, Pogue J, Reilly PA, Themeles E, Varrone J, Wang S, Alings M, Xavier D, Zhu J, Diaz R, Lewis BS, Darius H, Diener HC, Joyner CD, Wallentin L. Dabigatran versus Warfarin in Patients with Atrial Fibrillation.. N Engl J Med 2009 Aug 30;: - 10.1056.NEJM0a0905561
      Pubmed | Hubmed | Fulltext

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