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Related trials

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

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

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

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

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SPAF III, 1996 - warfarin + aspirin vs warfarin standard dose



See also:

  • All atrial fibrillation clinical trials
  • All clinical trials of new anticoagulants
  • All clinical trials of rivaroxaban
    		•  

    ROCKET-AF study, 2010

    [NCT00403767] Preliminary results 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)

    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% 
    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 up to 4 y
    Number of centre 1178
    Geographic area 45 countries
    Hypothesis Non inferiority
    Primary endpoint stroke or non-CNS systemic embolism


    Results

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

    major or clinically relevant non-major bleeding

    NA / 7131
         NA / 7133
         1,03 [0,96;1,11]

    All cause death

    NA / 7131
         NA / 7133
         0,92 [0,82;1,03]

    Cardiovascular death

    NA / 7131
         NA / 7133
         0,94 [0,81;1,09]

    thrombo-embolic event (cerebral or systemic)

    NA / 7131
         NA / 7133
         0,88 [0,75;1,04]

    ischemic stroke

    NA / 7131
         NA / 7133
         0,99 [0,82;1,20]

    MI (fatal and non fatal)

    NA / 7131
         NA / 7133
         0,91 [0,72;1,16]

    Fatal bleeding

    NA / 7131
         NA / 7133
         0,50 [0,31;0,80]

    Haemmorhagic stroke

    NA / 7131
         NA / 7133
         0,58 [0,38;0,89]

    intracranial hemorrhage

    NA / 7131
         NA / 7133
         0,67 [0,47;0,95]

    Major bleeding

    NA / 7131
         NA / 7133
         1,04 [0,90;1,20]     0 2 1.0

    Relative risks
    Endpoint Events (%) Relative Risk 95% CI Endpoint definition
    in the trial    		 Ref
    Studied treat. Control treat.
    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
    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

    new anticoagulants in atrial fibrillation for all type of patients



    Reference(s)

    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

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