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Systematic review and meta-analysis

This trial is included in the following systematic reviews and meta-analyses:

atrial fibrillation - antithrombotics - primary prevention of thromboembolic events


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See also:

  • All atrial fibrillation clinical trials
  • All clinical trials of antithrombotics
  • All clinical trials of warfarin + aspirin
  •  

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

    download pdf: warfarin + aspirin | antithrombotics for atrial fibrillation

    Treatments

    Studied treatment warfarin fixed low dose(1.25mg/d) + aspirin(300mg/d)
    Control treatment warfarin standard dose(target INR 2.0-3.0)
    Concomittant treatment Patients are informed not to take aspirin or NSAI drugs during the study period. If NSAI drugs are temporarily needed,the study treatment is interrupted for safety reasons.
    Remarks The trial includes 4 arms:fixed low dose warfarin (1.25mg/d),fixed low dose warfarin (1.25mg/d)+ aspirin 300mg,aspirin 300 mg and conventional warfarin therapy(target INR 2-3). The protocol allows 4 weeks per year without study treatment.

    Patients

    Patients chronic non valvular atrial fibrillation
    Inclusion criteria age>18;non valvuar atrial fibrillation documented on ECG twice,with an interval of at least one month.
    Exclusion criteria Patient under 60 with lone atrial fibrillation;thrombo-embolic event within the last 6 months;systolic blood pressure over 180mmHg or diastolic blood pressure over 100 mmHg;mitral stenosis;contraindication for warfarin or aspirin therapy;warfarin therapy based on other medical conditions,medical conditions requiring permanent nonsteroidal antiinflammatory drug therapy;noncompliance(alcoholism,psychiatric disease,dementia and foreign language);pregnancy and breast feeding.
    Baseline characteristics
    age(mean) 72.95 
    male(%) 58 
    systolic blood pressure(mean) 149.65 
    diastolic blood pressure(mean) 87.25 
    hypertension(%) 42.99 
    diabete mellitus(%) 14.5 
    prior TIA(%) 3.5 
    prior stroke(%) 7.01 
    left atrial dimension(mean in mm) 23.55 
    heart failure(%) 72.01 
    current smoker(%) 32 
    subgroup test

    Method and design

    Randomized effectives 171 / 170 (studied vs. control)
    Design Parallel groups
    Blinding Open
    Follow-up duration 3.5 years
    Premature discontinuation Premature discontinuation for futility
    Lost to follow-up no lost to follow up
    Number of centre 1
    Geographic area Denmark
    Hypothesis superiority
    Primary endpoint stroke or systemic thromboembolic event
    Remarks Mean follow-up duration was not reported. The discontinuation of study treatment was reported globally(25.1% for reasons other than primary or secondary adverse events). Though the primary analysis of the study was made according to an "on treatment" approach ,an "intention to treat" analysis was performed for thrombo-embolic events to allow comparison with other studies.
    Withdrawals (T1/T0) nr / nr


    Results

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

    thrombo-embolic event (cerebral or systemic)

    8 / 171
    4 / 170
    classic 1,99 [0,61;6,48]

    systemic thrombo-embolic complication

    1 / 171
    2 / 170
    classic 0,50 [0,05;5,43]

    stroke (fatal and non fatal)

    11 / 171
    11 / 170
    classic 0,99 [0,44;2,23]

    ischemic stroke

    8 / 171
    4 / 170
    classic 1,99 [0,61;6,48]

    myocardial infarction (fatal and non fatal)

    0 / 171
    4 / 170
    classic 0,06 [0,00;3,28]

    All cause death

    9 / 171
    17 / 170
    0,53 [0,24;1,15]

    Major bleeding

    1 / 171
    4 / 170
    classic 0,25 [0,03;2,20]

    Haemmorhagic stroke

    0 / 171
    1 / 170
    classic 0,20 [0,00;14,49]

    Cardiovascular death

    4 / 171
    5 / 170
    classic 0,80 [0,22;2,91]

    Fatal stroke

    0 / 171
    0 / 170
    classic 0,99 [0,00;253,10]

    TE event or ischemic stroke or systemic embolism

    8 / 171
    4 / 170
    classic 1,99 [0,61;6,48]

    intracranial hemorrhage

    0 / 171
    2 / 170
    classic 0,11 [0,00;6,84]
    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) 8 / 171 (4,7%) 4 / 170 (2,4%) 1,99 [0,61;6,48]  
    systemic thrombo-embolic complication 1 / 171 (0,6%) 2 / 170 (1,2%) 0,50 [0,05;5,43] systemic thromboembolic events in extremities,kidneys,mesenteric arteries,lungs,spleen,retina or grafts;verified using angiography,surgery,scintigraphy or autopsy 
    stroke (fatal and non fatal) 11 / 171 (6,4%) 11 / 170 (6,5%) 0,99 [0,44;2,23] acute onset of a focal neurogical deficit of presumed vascular genesis lasting for 24 hours or more 
    ischemic stroke 8 / 171 (4,7%) 4 / 170 (2,4%) 1,99 [0,61;6,48]  
    myocardial infarction (fatal and non fatal) 0 / 171 (0,3%) 4 / 170 (2,4%) 0,12 [0,01;2,33] 2 of the following criteria:history of typical chest pain,serial creatine kinase-MB changes typical of acute myocardial infarction, or ECG changes typical of acute myocardial infarction 
    All cause death 9 / 171 (5,3%) 17 / 170 (10,0%) 0,53 [0,24;1,15]  
    Major bleeding 1 / 171 (0,6%) 4 / 170 (2,4%) 0,25 [0,03;2,20] fatal,life threatening, requiring surgical treatment or blood transfusion(intracerebral bleeding included) 
    Haemmorhagic stroke 0 / 171 (0,3%) 1 / 170 (0,6%) 0,50 [0,02;14,72] traumatic intracranial hemorrhage excluded 
    Cardiovascular death 4 / 171 (2,3%) 5 / 170 (2,9%) 0,80 [0,22;2,91]  
    Fatal stroke 0 / 171 (0,3%) 0 / 170 (0,3%) 0,99 [0,02;49,82]  
    TE event or ischemic stroke or systemic embolism 8 / 171 (4,7%) 4 / 170 (2,4%) 1,99 [0,61;6,48] thrombo-embolic event, ischemic stroke or systemic embolism 
    intracranial hemorrhage 0 / 171 (0,3%) 2 / 170 (1,2%) 0,25 [0,01;5,47] traumatic intracranial hemorrhage excluded 
    The primary endpoint (if exists) appears in blod characters
    Reference(s) used for data extraction:
  • 0:

  • Endpoint studied treat. control treat. mean diff

    Absolute risk reduction
    Endpoint Events rate Absolute risk
    reduction (ARR)
    Studied treat. Control treat.
    thrombo-embolic event (cerebral or systemic) 4,68% 2,35% 2,3%
    systemic thrombo-embolic complication 5,85‰ 1,18% -5,9‰
    stroke (fatal and non fatal) 6,43% 6,47% -0,4‰
    ischemic stroke 4,68% 2,35% 2,3%
    All cause death 5,26% 10,00% -47,4‰
    Major bleeding 5,85‰ 2,35% -17,7‰
    Cardiovascular death 2,34% 2,94% -6,0‰
    TE event or ischemic stroke or systemic embolism 4,68% 2,35% 2,3%

    Meta-analysis of all similar trials:

    antithrombotics in atrial fibrillation for primary prevention of thromboembolic events



    Reference(s)

    Trials register # NA
    • Gullov AL, Koefoed BG, Petersen P, Pedersen TS, Andersen ED, Godtfredsen J, Boysen G. Fixed minidose warfarin and aspirin alone and in combination vs adjusted-dose warfarin for stroke prevention in atrial fibrillation: Second Copenhagen Atrial Fibrillation, Aspirin, and Anticoagulation Study.. Arch Intern Med 1998 Jul 27;158:1513-21
      Pubmed | Hubmed | Fulltext

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