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antithrombotics in pulmonary embolism for all type of patients, clinical trials results

anticoagulant versus no anticoagulant
BARRIT, 1960
heparin IV 10000 UI every 6 hours for 6 doses, nicoumalone ajusted for prothrombin time between 2-3x control
versus
no anticoagulant
patients with pulmonary embolism open
apixaban (without LMWH) versus LMWH/VKA
AMPLIFY, 2013
NCT00643201
apixaban 10 mg twice daily for 7 days then 5 mg, twice daily, 6 months
versus
conventional therapy: enoxaparin 1mg/kg twice daily until INR>=2 then warfarin for an INR between 2-4, once daikly, 6 months
patients with deep vein thrombosis or pulmonary embolism double blind
Follow-up duration: 6 mo
apixaban 2.5mg versus discontinuation
AMPLIFY-EXT 2.5mg, 2012
NCT00633893
Extended Treatment with apixaban 2.5 mg twice daily 12 months
versus
placebo
patients who have completed their intended treatment for deep vein thrombosis or pulmonary embolism double blind
Follow-up duration: 12 mo
apixaban 5mg versus discontinuation
AMPLIFY-EXT 5mg, 2012
NCT00633893
Extended Treatment with apixaban 5 mg twice daily 12 months
versus
placebo
patients who have completed their intended treatment for deep vein thrombosis or pulmonary embolism double blind
Follow-up duration: 12 mo
Certoparin versus unfractionated heparin
Certoparin-Study Group sub group, 1998
Certoparin, 8000 IU twice daily, 14 days
versus
Unfractioned heparin: bolus 5000 IU, infusion 20 IU/kg per hour
Symptomatic PEopen
Follow-up duration: 6 mo
Dalteparin versus unfractionated heparin
Kuijer, 1995
Dalteparin, 120 IU/kg twice daily, 5 days
versus
Unfractioned heparin: bolus 5000 IU, infusion 1250 IU/h
Symptomatic PEopen
Follow-up duration: 3 mo
Meyer, 1995
Dalteparin, 120 IU/kg twice daily, 10 days
versus
Unfractioned heparin: no bolus, infusion 500 IU/kg per day
Symptomatic PEopen
Follow-up duration: 3 mo
Enoxaparin versus unfractionated heparin
PREPIC, 1998
Enoxaparin, 1 mg/kg twice daily, 8-12 days
versus
Unfractioned heparin: bolus 5000 IU, infusion 500 IU/kg per day
patients with proximal deep-vein thrombosis who were at risk for pulmonary embolism open
Follow-up duration: 2 y
Merli sub group, 2001
Enoxaparin, 1mg/kg twice daily or 1.5 mg/kg once daily, 5 days
versus
Unfractioned heparin: according nomogram at local institution
patients with confirmed pulmonary embolismopen
Follow-up duration: 3 mo
16 countries
fondaparinux versus heparin
MATISSE PE, 2003
fondaparinux subcutaneously once daily
versus
continuous intravenous infusion of unfractionated heparin
patients with acute symptomatic pulmonary embolismopen
Follow-up duration: 3 mo
idrabiotaparinux versus warfarin
CASSIOPEA, 2012
NCT00345618
subcutaneous idrabiotaparinux (starting dose 3·0 mg) after 5-10 days' enoxaparin 1·0 mg/kg twice daily for at least 3 months or 6 months dependent on clinical presentation
versus
adjusted-dose warfarin (target INR 2-3) after 5-10 days' enoxaparin 1·0 mg/kg twice daily
adults with objectively documented acute symptomatic pulmonary embolismdouble-blind
Follow-up duration: 99 days
37 countries
idraparinux (without heparin) versus heparin/VKA
VanGogh PE, 2007
NCT00062803
subcutaneous idraparinux (2.5 mg once weekly)
versus
heparin followed by an adjusted-dose vitamin K antagonist
patients with pulmonary embolism open
Follow-up duration: 3 mo (6 mo)
Nadroparin versus unfractionated heparin
European multicentre study, 1991
Nadroparin, 4750–6650 antifactor Xa IU twice daily, 10 days
versus
Unfractioned heparin: no bolus, infusion, 20 IU/kg per hour
Symptomatic proximal DVTopen (blind assessment)
Follow-up duration: 3 mo
Europe
Prandoni sub-group, 1992
Nadroparin, 4750–6650 antifactor Xa IU twice daily, 10 days
versus
Unfractioned heparin: bolus 100 IU/kg, infusion 35 000 IU/d
Symptomatic proximal DVTopen
Follow-up duration: 6 mo
Thery, 1992
Nadroparin, 76 IU/kg twice daily, 14 days
versus
Unfractioned heparin: bolus 50 IU/kg, infusion 600 IU/kg per day
patients with submassive pulmonary embolism open
Follow-up duration: 14 d
outpatient treatment versus inpatient treatment
OTPE (Aujesky), 2011
NCT00425542
initial outpatient treatment with subcutaneous enoxaparin (¡Ý5 days) followed by oral anticoagulation (¡Ý90 days).
versus
inpatient treatment with subcutaneous enoxaparin (¡Ý5 days) followed by oral anticoagulation (¡Ý90 days)
patients with acute, symptomatic pulmonary embolism and a low risk of death (pulmonary embolism severity index risk classes I or II) open-label
Follow-up duration: 90 days
Switzerland, France, Belgium, and the USA
Otero, 2010
NCT00214929
early discharge
versus
standard hospitalization
low-risk patients with acute symptomatic PE open-label
Follow-up duration: 3 months
Spain
Reviparin versus unfractionated heparin
COLOMBUS sub group, 1997
Reviparin, 3500–6300 IU twice daily, 5 days
versus
Unfractioned heparin: bolus 5000 IU, infusion 1250 IU/h
patients with symptomatic DVT and associated pulmonary embolismopen
Follow-up duration: 3 mo
rivaroxaban (without LMWH) versus LMWH/VKA
Einstein-PE Evaluation, 2012
NCT00439777
rivaroxaban (15 mg twice daily for 3 weeks, followed by 20 mg once daily) for 3, 6, or 12 months
versus
standard therapy with enoxaparin followed by an adjusted-dose vitamin K antagonist
patients who had acute symptomatic pulmonary embolism with or without deep-vein thrombosisopen
Follow-up duration: 9.8 months
38 countries
Tinzaparin versus unfractionated heparin
ACTSG (Hull) sub-group, 1992
Tinzaparin, 175 IU/kg once daily, 6 days
versus
Unfractioned heparin: bolus 5000 IU, infusion 29 760–40 320 IU/d
patients with objectively documented PE and underlying proximal deep vein thrombosidouble blind
Follow-up duration: 3mo
US, Canada
THESEE, 1997
Tinzaparin, 175 IU/kg once daily, 5 days
versus
Unfractioned heparin: bolus 50 IU/kg, infusion 500 IU/kg per day
patients with symptomatic pulmonary embolism open
Follow-up duration: 3 mo
Campbell, 1998
Tinzaparin, 175 IU/kg once daily, 5 days
versus
Unfractioned heparin: bolus 5000 IU, infusion 1400 IU/h
Symptomatic PEopen
Follow-up duration: 3 mo

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