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Related trials

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AVERROES, 2011 - apixaban vs aspirin

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

ACTIVE W, 2006 - aspirin + clopidogrel vs anticoagulant

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SPORTIF V, 2005 - ximelagatran vs warfarin 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

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

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SPORTIF III, 2003 - ximelagatran vs warfarin standard dose

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

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

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

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



See also:

  • All atrial fibrillation clinical trials
  • All clinical trials of new oral anticoagulants
  • All clinical trials of rivaroxaban
  •  
     ROCKET-AF study, 2010 TRC7222 
    [NCT00403767] download pdf: rivaroxaban | antithrombotics for atrial fibrillation

    Treatments

    Studied treatment Rivaroxaban 20mg p.o. once daily
    (15 mg for Creatinine Cl 30-49 ml/min)
    Control treatment Warfarin p.o. once daily titrated to a target INR of 2.5 (range 2.0 to 3.0, inclusive)
    Treatments description
    time within the therapeutic range (%) 55% (median 58%) 

    Patients

    Patients Subjects With Non-Valvular Atrial Fibrillation
    Inclusion criteria Male and female patients 18 years of age or older; Subjects must have documented atrial fibrillation on 2 separate occasions within 6 months before screening ; History of a prior stroke, transient ischemic attack or non-neurologic systemic embolism believed to be cardiac in origin, OR at least two of the following risk factors: Heart failure , Hypertension, Age 75 years or greater , Diabetes mellitus
    Exclusion criteria Significant mitral stenosis;Transient atrial fibrillation caused by a reversible disorder ;Active internal bleeding ; Severe disabling stroke ; History of intracranial bleeding Hemorrhagic disorders
    Baseline characteristics
    age(mean) 73y 
    male(%) 60% 
    hypertension(%) 90.5% 
    diabete mellitus(%) 39.5% 
    prior TIA or stroke(%) 55% (stroke,TIA, embolism) 
    prior myocardial infarction(%) 17.5% 
    subgroup test
    CHADS2 Score (mean) 3.47 
    CHADS2 Score = 2 (%) 13% 
    CHADS2 Score = 3 (%) 43.5% 

    Method and design

    Randomized effectives 7131 / 7133 (studied vs. control)
    Design Parallel groups
    Blinding double blind
    Follow-up duration median 1.94 y
    Lost to follow-up 0.22% (32)
    Number of centre 1178
    Geographic area 45 countries
    Hypothesis Non inferiority
    Primary endpoint stroke or non-CNS systemic embolism
    Withdrawals (T1/T0) 23.7% / 22.2%


    Results

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

    Coronary event

    101 / 7111
    126 / 7125
    0,80 [0,62;1,04]

    thrombo-embolic event (cerebral or systemic)

    269 / 7081
    306 / 7090
    0,88 [0,75;1,03]

    systemic thrombo-embolic complication

    NA / 7131
    NA / 7133
    0,74 [0,42;1,31]

    stroke (fatal and non fatal)

    184 / 7061
    221 / 7082
    0,84 [0,69;1,01]

    ischemic stroke

    149 / 7061
    161 / 7082
    0,93 [0,74;1,16]

    myocardial infarction (fatal and non fatal)

    101 / 7061
    126 / 7082
    0,80 [0,62;1,04]

    All cause death

    208 / 7061
    250 / 7082
    0,83 [0,70;1,00]

    Major bleeding

    395 / 7111
    386 / 7125
    1,03 [0,89;1,18]

    Haemmorhagic stroke

    29 / 7061
    50 / 7082
    0,58 [0,37;0,92]

    Fatal bleeding

    27 / 7111
    55 / 7125
    0,49 [0,31;0,78]

    Gastrointestinal major bleeding

    224 / 7111
    154 / 7125
    1,46 [1,19;1,78]

    major or clinically relevant non-major bleeding

    1475 / 7111
    1449 / 7125
    1,02 [0,96;1,09]

    Cardiovascular death

    170 / 7061
    193 / 7082
    0,88 [0,72;1,08]

    Fatal stroke

    47 / 7061
    67 / 7082
    0,70 [0,49;1,02]

    Lifethreatening major bleeding

    91 / 7111
    133 / 7125
    0,69 [0,53;0,89]

    intracranial hemorrhage

    55 / 7111
    84 / 7125
    0,66 [0,47;0,92]
    0 2 1.0

    Relative risks
    Endpoint Events (%) Relative Risk 95% CI Endpoint definition
    in the trial
    Ref
    Studied treat. Control treat.
    Coronary event 101 / 7111 (1,4%) 126 / 7125 (1,8%) 0,80 [0,62;1,04]   16949
    thrombo-embolic event (cerebral or systemic) 269 / 7081 (3,8%) 306 / 7090 (4,3%) 0,88 [0,75;1,03] ITT n=14171  14871
    systemic thrombo-embolic complication NA / 7131 NA / 7133 0,74 [0,42;1,31] Non-CNS Embolism   
    stroke (fatal and non fatal) 184 / 7061 (2,6%) 221 / 7082 (3,1%) 0,84 [0,69;1,01] Safety, as-treated population  14871
    ischemic stroke 149 / 7061 (2,1%) 161 / 7082 (2,3%) 0,93 [0,74;1,16] Safety, as-treated population  14871
    myocardial infarction (fatal and non fatal) 101 / 7061 (1,4%) 126 / 7082 (1,8%) 0,80 [0,62;1,04] Safety, as-treated population  14871
    All cause death 208 / 7061 (2,9%) 250 / 7082 (3,5%) 0,83 [0,70;1,00] Safety, as-treated population  14871
    Major bleeding 395 / 7111 (5,6%) 386 / 7125 (5,4%) 1,03 [0,89;1,18]   14871
    Haemmorhagic stroke 29 / 7061 (0,4%) 50 / 7082 (0,7%) 0,58 [0,37;0,92] Hemorrhagic stroke, Safety, as-treated population  14871
    Fatal bleeding 27 / 7111 (0,4%) 55 / 7125 (0,8%) 0,49 [0,31;0,78] Bleeding causing death  14871
    Gastrointestinal major bleeding 224 / 7111 (3,2%) 154 / 7125 (2,2%) 1,46 [1,19;1,78]   14871
    major or clinically relevant non-major bleeding 1475 / 7111 (20,7%) 1449 / 7125 (20,3%) 1,02 [0,96;1,09]   14871
    Cardiovascular death 170 / 7061 (2,4%) 193 / 7082 (2,7%) 0,88 [0,72;1,08] Safety, as-treated population  14871
    Fatal stroke 47 / 7061 (0,7%) 67 / 7082 (0,9%) 0,70 [0,49;1,02] Safety, as-treated population  14871
    Lifethreatening major bleeding 91 / 7111 (1,3%) 133 / 7125 (1,9%) 0,69 [0,53;0,89] critical bleeding  14871
    intracranial hemorrhage 55 / 7111 (0,8%) 84 / 7125 (1,2%) 0,66 [0,47;0,92]   14871
    The primary endpoint (if exists) appears in blod characters
    Reference(s) used for data extraction:
  • 14871: Patel MR, Mahaffey KW, Garg J, Pan G, Singer DE, Hacke W, Breithardt G, Halperin JL, Hankey GJ, Piccini JP, Becker RC, Nessel CC, Paolini JF, Berkowitz SD, Fox KA, Califf RMRivaroxaban versus Warfarin in Nonvalvular Atrial Fibrillation.N Engl J Med 2011 Aug 10;:
  • 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 (for a follow-up of median 1.94 y)
    Endpoint Events rate Absolute risk
    reduction (ARR)
    Studied treat. Control treat.
    Coronary event 1,42% 1,77% -0,35%
    thrombo-embolic event (cerebral or systemic) 3,80% 4,32% -0,52%
    stroke (fatal and non fatal) 2,61% 3,12% -0,51%
    ischemic stroke 2,11% 2,27% -0,16%
    myocardial infarction (fatal and non fatal) 1,43% 1,78% -0,35%
    All cause death 2,95% 3,53% -0,58%
    Major bleeding 5,55% 5,42% 0,14%
    Haemmorhagic stroke 4,11‰ 7,06‰ -0,30%
    Fatal bleeding 3,80‰ 7,72‰ -0,39%
    Gastrointestinal major bleeding 3,15% 2,16% 0,99%
    major or clinically relevant non-major bleeding 20,74% 20,34% 0,41%
    Cardiovascular death 2,41% 2,73% -0,32%
    Fatal stroke 6,66‰ 9,46‰ -0,28%
    Lifethreatening major bleeding 1,28% 1,87% -0,59%
    intracranial hemorrhage 7,73‰ 1,18% -0,41%

    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)

    TrialResults-center ID TRC7222
    Trials register # NCT00403767
    Study web site link ,
    • . Rivaroxaban-once daily, oral, direct factor Xa inhibition compared with vitamin K antagonism for prevention of stroke and Embolism Trial in Atrial Fibrillation: rationale and design of the ROCKET AF study.. Am Heart J 2010;159:340-347.e1 - 10.1016/j.ahj.2009.11.025
      Pubmed | Hubmed | Fulltext
    • Patel MR, Mahaffey KW, Garg J, Pan G, Singer DE, Hacke W, Breithardt G, Halperin JL, Hankey GJ, Piccini JP, Becker RC, Nessel CC, Paolini JF, Berkowitz SD, Fox KA, Califf RM. Rivaroxaban versus Warfarin in Nonvalvular Atrial Fibrillation.. N Engl J Med 2011 Aug 10;: - 10.1056/NEJMoa1009638
      Pubmed | Hubmed | Fulltext

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