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

Gonz�lez-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

Lopez-Beret, 2001 - Nadroparin vs acenocoumarol

Merli, 2001 - once daily enoxaparin vs twice daily enoxaparin



See also:

  • All venous thrombosis clinical trials
    		•  

    Romera study, 2009

    Treatments

    Studied treatment tinzaparin SC 175 IU anti-Xa per kg once daily for 6 months
    Control treatment acenocoumarol for target INR 2-3 for 6 months after initial LMWH (until INR 2-3)

    Patients

    Patients patients with symptomatic proximal DVT of the lowerlimbs confirmed by compression duplex ultrasound scan
    Baseline characteristics
    cancer (%) 28.6% 

    Method and design

    Randomized effectives 119 / 122 (studied vs. control)
    Design Parallel groups
    Blinding open
    Follow-up duration 12 months
    Lost to follow-up NA
    Number of centre 2
    Geographic area Spain
    Primary endpoint symptomatic recurrent venous thromboembolism


    Results

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

    Recurrent thromboembolic event

    6 / 119
         13 / 122
         0,47 [0,19;1,20]

    puylmonary embolism

    4 / 119
         3 / 122
         classic 1,37 [0,31;5,98]

    Bleeding

    1 / 119
         3 / 122
         classic 0,34 [0,04;3,24]

    recurrent DVT

    2 / 119
         10 / 122
         0,21 [0,05;0,92]

    VTE during active anticoagulant treatment

    5 / 119
         7 / 122
         classic 0,73 [0,24;2,24]

    VTE during follow-up after active anticoagulant treatment

    1 / 119
         6 / 122
         0,17 [0,02;1,40]     0 2 1.0

    Relative risks
    Endpoint Events (%) Relative Risk 95% CI Endpoint definition
    in the trial
    Studied treat. Control treat.
    Recurrent thromboembolic event 6 / 119 (5,0%) 13 / 122 (10,7%) 0,47 [0,19;1,20]  
    puylmonary embolism 4 / 119 (3,4%) 3 / 122 (2,5%) 1,37 [0,31;5,98] at the end of trial 
    Bleeding 1 / 119 (0,8%) 3 / 122 (2,5%) 0,34 [0,04;3,24]  
    recurrent DVT 2 / 119 (1,7%) 10 / 122 (8,2%) 0,21 [0,05;0,92] at the end of the trial 
    VTE during active anticoagulant treatment 5 / 119 (4,2%) 7 / 122 (5,7%) 0,73 [0,24;2,24]  
    VTE during follow-up after active anticoagulant treatment 1 / 119 (0,8%) 6 / 122 (4,9%) 0,17 [0,02;1,40]  
    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 5,04% 10,66% -56,1‰
    puylmonary embolism 3,36% 2,46% 9,0‰
    Bleeding 8,40‰ 2,46% -16,2‰
    recurrent DVT 1,68% 8,20% -65,2‰
    VTE during active anticoagulant treatment 4,20% 5,74% -15,4‰
    VTE during follow-up after active anticoagulant treatment 8,40‰ 4,92% -40,8‰


    Reference(s)

    Trials register # NA
    • Romera A, Cairols MA, Vila-Coll R, Mart� X, Colom� E, Bonell A, Lapiedra O. A randomised open-label trial comparing long-term sub-cutaneous low-molecular-weight heparin compared with oral-anticoagulant therapy in the treatment of deep venous thrombosis.. Eur J Vasc Endovasc Surg 2009;37:349-56
      Pubmed | Hubmed | Fulltext

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

    Tweet this  |  notify a friend