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See also:

  • All pulmonary embolism clinical trials
  • All venous thrombosis clinical trials
  • All clinical trials of direct oral anticoagulant (DAO)
  • All clinical trials of apixaban (without LMWH)
  •  
     AMPLIFY study, 2013 TRC10328 
    [NCT00643201] download pdf: apixaban (without LMWH) | antithrombotics for venous thrombosis

    Treatments

    Studied treatment apixaban 10 mg twice daily for 7 days then 5 mg, twice daily, 6 months
    Control treatment conventional therapy: enoxaparin 1mg/kg twice daily until INR>=2 then warfarin for an INR between 2-4, once daikly, 6 months

    Patients

    Patients patients with deep vein thrombosis or pulmonary embolism
    Exclusion criteria contraindications for enoxaparin or warfarin; active bleeding or high risk for serious bleeding; short life expectancy; uncontrolled high blood pressure; significantly impaired kidney or liver function

    Method and design

    Randomized effectives 2691 / 2704 (studied vs. control)
    Design Parallel groups
    Blinding double blind
    Follow-up duration 6 mo
    Primary endpoint Venous thromboembolic recurrence or death


    Results



    Endpoints and data reported in the trial's publication(s)

    Endpoint Events (%) Relative Risk 95% CI
    Studied treat. Control treat.
    First recurrent VTE or VTE-related death — no. (%) 59 / 2609 (2,3%) 71 / 2635 (2,7%) 0,84 [0,60;1,18]
    Fatal PE 1 / 2609 (0,0%) 2 / 2635 (0,1%) 0,50 [0,05;5,57]
    Death for which PE could not be ruled out 11 / 2609 (0,4%) 13 / 2635 (0,5%) 0,85 [0,38;1,90]
    Nonfatal PE with or without DVT 27 / 2609 (1,0%) 23 / 2635 (0,9%) 1,19 [0,68;2,06]
    DVT only 20 / 2609 (0,8%) 33 / 2635 (1,3%) 0,61 [0,35;1,06]
    Major bleeding — no. (%)‡ 15 / 2676 (0,6%) 49 / 2689 (1,8%) 0,31 [0,17;0,55]
    Fatal bleeding¶ 1 / 2676 (0,0%) 2 / 2689 (0,1%) 0,50 [0,05;5,54]
    Nonfatal major bleeding at a critical site 4 / 2676 (0,1%) 14 / 2689 (0,5%) 0,29 [0,09;0,87]
    Intracranial Nonfatal major bleeding 3 / 2676 (0,1%) 6 / 2689 (0,2%) 0,50 [0,13;2,01]
    Retroperitoneal Nonfatal major bleeding 1 / 2676 (0,0%) 3 / 2689 (0,1%) 0,33 [0,03;3,22]
    Intrathoracic Nonfatal major bleeding 0 / 2676 (0,0%) 1 / 2689 (0,0%) 0,50 [0,02;14,97]
    Intraocular Nonfatal major bleeding 0 / 2676 (0,0%) 2 / 2689 (0,1%) 0,25 [0,01;5,57]
    Intraarticular Nonfatal major bleeding 0 / 2676 (0,0%) 2 / 2689 (0,1%) 0,25 [0,01;5,57]
    Other nonfatal major bleeding 10 / 2676 (0,4%) 33 / 2689 (1,2%) 0,30 [0,15;0,62]
    Gastrointestinal Nonfatal major bleeding 7 / 2676 (0,3%) 18 / 2689 (0,7%) 0,39 [0,16;0,93]
    Intramuscular Nonfatal major bleeding 0 / 2676 (0,0%) 5 / 2689 (0,2%) 0,10 [0,01;1,84]
    Epistaxis non fatal 1 / 2676 (0,0%) 1 / 2689 (0,0%) 1,00 [0,06;16,06]
    Urogenital Nonfatal major bleeding 1 / 2676 (0,0%) 3 / 2689 (0,1%) 0,33 [0,03;3,22]
    non fatal Subcutaneous hematoma 1 / 2676 (0,0%) 6 / 2689 (0,2%) 0,17 [0,02;1,39]
    all cause death 41 / 2676 (1,5%) 52 / 2689 (1,9%) 0,79 [0,53;1,19]
    41 / 2676 (1,5%) 52 / 2689 (1,9%) 0,79 [0,53;1,19]
    death PE or PE not ruled out 12 / 2676 (0,4%) 16 / 2689 (0,6%) 0,75 [0,36;1,59]
    death Cardiovascular cause 3 / 2676 (0,1%) 7 / 2689 (0,3%) 0,43 [0,11;1,66]
    death Bleeding 2 / 2676 (0,1%) 3 / 2689 (0,1%) 0,67 [0,11;4,01]
    death Cancer 14 / 2676 (0,5%) 14 / 2689 (0,5%) 1,00 [0,48;2,10]
    death Infectious disease 9 / 2676 (0,3%) 7 / 2689 (0,3%) 1,29 [0,48;3,46]
    death Other 1 / 2676 (0,0%) 5 / 2689 (0,2%) 0,20 [0,02;1,72]
    VTE or death from cardiovascular cause 61 / 2609 (2,3%) 77 / 2635 (2,9%) 0,80 [0,57;1,11]
    VTE or death from any cause 84 / 2609 (3,2%) 104 / 2635 (3,9%) 0,82 [0,62;1,08]
    VTE, VTE-related death, or major bleeding 73 / 2609 (2,8%) 118 / 2635 (4,5%) 0,62 [0,47;0,83]
    Any Adverse events during treatment 1795 / 2676 (67,1%) 1923 / 2689 (71,5%) 0,94 [0,91;0,97]
    Any serious adverse event during treatment 417 / 2676 (15,6%) 410 / 2689 (15,2%) 1,02 [0,90;1,16]
    Any bleeding event 415 / 2676 (15,5%) 695 / 2689 (25,8%) 0,60 [0,54;0,67]
    Any adverse event resulting in permanent discontinuation of study drug 162 / 2676 (6,1%) 199 / 2689 (7,4%) 0,82 [0,67;1,00]
    Clinically relevant nonmajor bleeding 103 / 2676 (3,8%) 215 / 2689 (8,0%) 0,48 [0,38;0,61]
    Major bleeding or clinically relevant nonmajor bleeding 115 / 2676 (4,3%) 261 / 2689 (9,7%) 0,44 [0,36;0,55]

    Endpoints used by the meta-analysis and data retained for this trial

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

    Major bleeding

    15 / 2676
    49 / 2689
    0,31 [0,17;0,55]

    Symptomatic deep-vein thrombosis

    20 / 2609
    33 / 2635
    0,61 [0,35;1,06]

    Death related to venous thromboembolism

    11 / 2609
    13 / 2635
    0,85 [0,38;1,90]

    fatal pulmonary embolism

    1 / 2609
    2 / 2635
    classic 0,50 [0,05;5,57]

    VTE

    59 / 2609
    71 / 2635
    0,84 [0,60;1,18]

    recurrent VTE during treatment

    59 / 2609
    71 / 2635
    0,84 [0,60;1,18]

    symptomatic pulmonary embolism

    27 / 2609
    23 / 2635
    classic 1,19 [0,68;2,06]

    All cause death

    41 / 2676
    52 / 2689
    0,79 [0,53;1,19]

    non-fatal pulmonary embolism

    27 / 2609
    23 / 2635
    classic 1,19 [0,68;2,06]
    0 2 1.0

    Relative risks
    Endpoint Events (%) Relative Risk 95% CI Endpoint definition
    in the trial
    Ref
    Studied treat. Control treat.
    Major bleeding 15 / 2676 (0,6%) 49 / 2689 (1,8%) 0,31 [0,17;0,55] Major bleeding — no. (%)‡ 
    recurrent VTE during treatment 59 / 2609 (2,3%) 71 / 2635 (2,7%) 0,84 [0,60;1,18] First recurrent VTE or VTE-related death — no. (%) 
    symptomatic pulmonary embolism 27 / 2609 (1,0%) 23 / 2635 (0,9%) 1,19 [0,68;2,06] Nonfatal PE with or without DVT 
    All cause death 41 / 2676 (1,5%) 52 / 2689 (1,9%) 0,79 [0,53;1,19] all cause death 
    non-fatal pulmonary embolism 27 / 2609 (1,0%) 23 / 2635 (0,9%) 1,19 [0,68;2,06] Nonfatal PE with or without DVT 
    VTE 59 / 2609 (2,3%) 71 / 2635 (2,7%) 0,84 [0,60;1,18] First recurrent VTE or VTE-related death — no. (%) 
    Symptomatic deep-vein thrombosis 20 / 2609 (0,8%) 33 / 2635 (1,3%) 0,61 [0,35;1,06] DVT only 
    Death related to venous thromboembolism 11 / 2609 (0,4%) 13 / 2635 (0,5%) 0,85 [0,38;1,90] Death for which PE could not be ruled out 
    fatal pulmonary embolism 1 / 2609 (0,0%) 2 / 2635 (0,1%) 0,50 [0,05;5,57] Fatal PE 
    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 (for a follow-up of 6 mo)
    Endpoint Events rate Absolute risk
    reduction (ARR)
    Studied treat. Control treat.
    Major bleeding 5,61‰ 1,82% -1,26%
    recurrent VTE during treatment 2,26% 2,69% -0,43%
    symptomatic pulmonary embolism 1,03% 8,73‰ 0,16%
    All cause death 1,53% 1,93% -0,40%
    non-fatal pulmonary embolism 1,03% 8,73‰ 0,16%
    VTE 2,26% 2,69% -0,43%
    Symptomatic deep-vein thrombosis 7,67‰ 1,25% -0,49%
    Death related to venous thromboembolism 4,22‰ 4,93‰ -0,07%
    fatal pulmonary embolism 0,38‰ 0,76‰ -0,04%

    Meta-analysis of all similar trials:

    antithrombotics in pulmonary embolism for all type of patients

    antithrombotics in venous thrombosis for all type of patients

    direct oral anticoagulant (DAO) in venous thrombosis for all types of patients



    Reference(s)

    TrialResults-center ID TRC10328
    Trials register # NCT00643201
    • Agnelli G, Buller HR, Cohen A, Curto M, Gallus AS, Johnson M, Masiukiewicz U, Pak R, Thompson J, Raskob GE, Weitz JI. Oral apixaban for the treatment of acute venous thromboembolism.. N Engl J Med 2013 Aug 29;369:799-808 - 10.1056/NEJMoa1302507
      Pubmed | Hubmed | Fulltext

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