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

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See also:

  • All atrial fibrillation clinical trials
  • All clinical trials of new oral anticoagulants
  • All clinical trials of dabigatran 150mg
  •  
     PETRO (150mg) study, 2007 TRC7217 
    download pdf: dabigatran 150mg | antithrombotics for atrial fibrillation

    Treatments

    Studied treatment dabigatran 150 mg twice daily (alone or combined with 81- or 325-mg aspirin)
    Control treatment warfarin administered to achieve an international normalized ratio of 2 to 3 for
    Remarks factorial design: Three doses of dabigatran etexilate (50, 150, and 300 mg twice daily) were combined in a 3 3 factorial fashion with no aspirin or 81- or 325-mg aspirin once daily.

    Patients

    Patients patients with AF at high risk for thromboembolic events
    Baseline characteristics
    age(mean) 70y 
    hypertension(%) 71% 
    diabete mellitus(%) 25% 
    prior TIA or stroke(%) 17.3% 
    heart failure(%) 29.3% 
    current smoker(%) 72.7% 
    subgroup test

    Method and design

    Randomized effectives 166 / 70 (studied vs. control)
    Design Factorial plan
    Blinding double blind
    Follow-up duration 12 weeks
    Number of centre 53
    Geographic area Denmark, The netehrlands, Sweden, US
    Primary endpoint bleedings


    Results

    No results available for this trial - no clinical endpoint reported

    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 TRC7217
    Trials register # NA
    Study web site link ,
    • Ezekowitz MD, Reilly PA, Nehmiz G, Simmers TA, Nagarakanti R, Parcham-Azad K, Pedersen KE, Lionetti DA, Stangier J, Wallentin L. Dabigatran with or without concomitant aspirin compared with warfarin alone in patients with nonvalvular atrial fibrillation (PETRO Study).. Am J Cardiol 2007;100:1419-26
      Pubmed | Hubmed | Fulltext

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