Trial-Results center  
Clinical trial results database Feedback    Home


Related trials

Lopaciuk, 3000 - subcutaneous heparin vs intravenous heparin

RE-COVER, 2009 - dabigatran vs vitamin K antagonists

Romera, 2009 - Tinzaparin vs acenocoumarol

González-Fajardo, 2008 - Enoxaparin vs coumarin

Botticelli DVT, 2008 - apixaban vs heparin/VKA

Einstein-DVT Dose-Ranging Study, 2008 - rivaroxaban vs heparin/VKA

VanGogh DVT, 2007 - idraparinux vs heparin/VKA

VanGogh PE, 2007 - idraparinux vs heparin/VKA

Daskalopoulos, 2005 - LMWH at home vs UFH in hospital

Fiessinger , 2005 - ximelagatran vs vitamin K antagonists

Chong, 2005 - LMWH at home vs UFH in hospital

Kearon, 2004 - 4 months vs 3 months

Ramacciotti, 2004 - LMWH at home vs UFH in hospital

MATISSE, 2004 - fondaparinux vs enoxaparin

Lee, 2003 - Dalteparin vs warfarin

Agnelli, 2003 - 6-12 months vs 3 months

Kakkar, 2003 - Bemiparin vs warfarin

Deitcher, 2003 - Enoxaparin vs warfarin

MATISSE PE, 2003 - fondaparinux vs heparin/VKA

Hull, 2002 - Tinzaparin vs warfarin

Meyer, 2002 - Enoxaparin vs warfarin

Agnelli, 2001 - 12 months vs 3 months

Merli (once daily vs UFH), 2001 - once daily enoxaparin vs UFH

Merli sub group, 2001 - Enoxaparin vs unfractioned heparin

Lopez-Beret, 2001 - Nadroparin vs acenocoumarol



See also:

  • All pulmonary embolism clinical trials
  • All venous thrombosis clinical trials
  •  

    MATISSE PE study, 2003

    Treatments

    Studied treatment fondaparinux subcutaneously once daily
    fondaparinux (5.0, 7.5, or 10.0 mg in patients weighing less than 50, 50 to 100, or more than 100 kg, respectively) subcutaneously once daily, given for at least five days and until the use of vitamin K antagonists resulted in an international normalized ratio above 2.0
    Control treatment continuous intravenous infusion of unfractionated heparin
    (ratio of the activated partial-thromboplastin time to a control value, 1.5 to 2.5), given for at least five days and until the use of vitamin K antagonists resulted in an international normalized ratio above 2.0

    Patients

    Patients patients with acute symptomatic pulmonary embolism
    Inclusion criteria patients 18 years of age or older who presented with acute symptomatic pulmonary embolism and who required antithrombotic therapy were potentially eligible for the study. Diagnostic criteria were an intraluminal filling defect on spiral computed tomography (CT) or pulmonary angiography, a high-probability ventilation–perfusion lung scan, or a nondiagnostic lung scan with documentation of deep-vein thrombosis either by compression ultrasonography or by venography
    Baseline characteristics
    Age 62.5y 
    female (%) 27.2% 

    Method and design

    Randomized effectives 1103 / 1110 (studied vs. control)
    Design Parallel groups
    Blinding open
    Follow-up duration 3 mo
    Number of centre 235
    Primary endpoint symptomatic recurrent/new VTE


    Results

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

    Recurrent thromboembolic event

    42 / 1103
    56 / 1110
    0,75 [0,51;1,12]

    All cause death

    57 / 1092
    48 / 1092
    1,19 [0,82;1,73]

    Major bleeding

    22 / 1092
    26 / 1092
    0,85 [0,48;1,48]
    0 2 1.0

    Relative risks
    Endpoint Events (%) Relative Risk 95% CI Endpoint definition
    in the trial
    Studied treat. Control treat.
    Recurrent thromboembolic event 42 / 1103 (3,8%) 56 / 1110 (5,0%) 0,75 [0,51;1,12] entire study  
    Major bleeding 22 / 1092 (2,0%) 26 / 1092 (2,4%) 0,85 [0,48;1,48]  
    All cause death 57 / 1092 (5,2%) 48 / 1092 (4,4%) 1,19 [0,82;1,73]  
    The primary endpoint (if exists) appears in blod characters

    Endpoint studied treat. control treat. mean diff

    Absolute risk reduction
    Endpoint Events rate Absolute risk
    reduction (ARR)
    Studied treat. Control treat.
    Recurrent thromboembolic event 3,81% 5,05% -12,4‰
    Major bleeding 2,01% 2,38% -3,7‰
    All cause death 5,22% 4,40% 8,2‰


    Reference(s)

    Trials register # NA
    • Büller HR, Davidson BL, Decousus H, Gallus A, Gent M, Piovella F, Prins MH, Raskob G, van den Berg-Segers AE, Cariou R, Leeuwenkamp O, Lensing AW. Subcutaneous fondaparinux versus intravenous unfractionated heparin in the initial treatment of pulmonary embolism.. N Engl J Med 2003 Oct 30;349:1695-702
      Pubmed | Hubmed | Fulltext

    (c) 2004-2010 TrialResults-center - All Rights Reserved

    Tweet this  |  notify a friend