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Systematic review and meta-analysis

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

venous thrombosis - antithrombotics - secondary prevention of VTE


Related trials

ASPIRE, 2012 - aspirin vs discontinuation

AMPLIFY-EXT 2.5mg, 2012 - apixaban 2.5mg vs discontinuation

WARFASA, 2012 - aspirin vs discontinuation

AMPLIFY-EXT 5mg, 2012 - apixaban 5mg vs discontinuation

RE-MEDY, 2011 - dabigatran vs warfarin

RE-SONATE, 2011 - dabigatran vs discontinuation

EINSTEIN-extension, 2009 - rivaroxaban vs discontinuation

VanGogh extension, 2007 - idraparinux vs discontinuation

PROLONG (Palareti), 2006 - warfarin vs discontinuation

THRIVE III, 2003 - ximelagatran vs discontinuation

PREVENT (Ridker), 2003 - warfarin vs discontinuation

Agnelli, 2003 - warfarin vs discontinuation

Agnelli, 2001 - warfarin vs discontinuation

Kearon, 1999 - warfarin vs discontinuation

Schulman, 1997 - warfarin vs discontinuation

Levine, 1995 - warfarin vs discontinuation



See also:

  • All venous thrombosis clinical trials
  • All clinical trials of antithrombotics
  • All clinical trials of aspirin
  •  

    WARFASA study, 2012

    [NCT00222677] download pdf: aspirin | antithrombotics for venous thrombosis

    Treatments

    Studied treatment aspirin, 100 mg daily for 2 years
    Control treatment placebo

    Patients

    Patients patients with first-ever unprovoked venous thromboembolism who had completed 6 to 18 months of oral anticoagulant treatment

    Method and design

    Randomized effectives 205 / 197 (studied vs. control)
    Design Parallel groups
    Blinding double-blind
    Follow-up duration 24.6 mo (median)
    Number of centre multicenter
    Primary endpoint recurrence of venous thromboembolism


    Results

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

    Major bleeding

    1 / 205
    1 / 197
    classic 0,96 [0,06;15,26]

    recurrent DVT

    16 / 205
    28 / 197
    0,55 [0,31;0,98]

    major or clinically relevant non-major bleeding

    4 / 205
    4 / 197
    classic 0,96 [0,24;3,79]

    VTE

    28 / 205
    43 / 197
    0,63 [0,41;0,97]

    All cause death

    6 / 205
    5 / 197
    classic 1,15 [0,36;3,72]

    puylmonary embolism

    11 / 205
    14 / 197
    0,76 [0,35;1,62]

    fatal pulmonary embolism

    1 / 205
    1 / 197
    classic 0,96 [0,06;15,26]
    0 2 1.0

    Relative risks
    Endpoint Events (%) Relative Risk 95% CI Endpoint definition
    in the trial
    Ref
    Studied treat. Control treat.
    Major bleeding 1 / 205 (0,5%) 1 / 197 (0,5%) 0,96 [0,06;15,26] study follow-up  15540
    recurrent DVT 16 / 205 (7,8%) 28 / 197 (14,2%) 0,55 [0,31;0,98]   15540
    major or clinically relevant non-major bleeding 4 / 205 (2,0%) 4 / 197 (2,0%) 0,96 [0,24;3,79]   15540
    VTE 28 / 205 (13,7%) 43 / 197 (21,8%) 0,63 [0,41;0,97]   15540
    All cause death 6 / 205 (2,9%) 5 / 197 (2,5%) 1,15 [0,36;3,72]   15540
    puylmonary embolism 11 / 205 (5,4%) 14 / 197 (7,1%) 0,76 [0,35;1,62]   15540
    fatal pulmonary embolism 1 / 205 (0,5%) 1 / 197 (0,5%) 0,96 [0,06;15,26]   15540
    The primary endpoint (if exists) appears in blod characters
    Reference(s) used for data extraction:
  • 15540: Becattini C, Agnelli G, Schenone A, Eichinger S, Bucherini E, Silingardi M, Bianchi M, Moia M, Ageno W, Vandelli MR, Grandone E, Prandoni PAspirin for preventing the recurrence of venous thromboembolism.N Engl J Med 2012 May 24;366:1959-67

  • Endpoint studied treat. control treat. mean diff

    Absolute risk reduction
    Endpoint Events rate Absolute risk
    reduction (ARR)
    Studied treat. Control treat.
    Major bleeding 4,88‰ 5,08‰ -0,2‰
    recurrent DVT 7,80% 14,21% -64,1‰
    major or clinically relevant non-major bleeding 1,95% 2,03% -0,8‰
    VTE 13,66% 21,83% -81,7‰
    All cause death 2,93% 2,54% 3,9‰
    puylmonary embolism 5,37% 7,11% -17,4‰
    fatal pulmonary embolism 4,88‰ 5,08‰ -0,2‰

    Meta-analysis of all similar trials:

    antithrombotics in venous thrombosis for secondary prevention of VTE



    Reference(s)

    Trials register # NCT00222677
    • Becattini C, Agnelli G, Schenone A, Eichinger S, Bucherini E, Silingardi M, Bianchi M, Moia M, Ageno W, Vandelli MR, Grandone E, Prandoni P. Aspirin for preventing the recurrence of venous thromboembolism.. N Engl J Med 2012 May 24;366:1959-67 - 10.1056/NEJMoa1114238
      Pubmed | Hubmed | Fulltext

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