pulmonary embolism 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 PE	open 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 PE	open 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 PE	open Follow-up duration: 3 mo
desmoteplase versus alteplase
Tebbe, 2009	125, 180, and 250 microg/kg bodyweight desmoteplase versus 100 mg alteplase	acute massive pulmonary thromboembolism	NA
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 embolism	open 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 embolism	open Follow-up duration: 3 mo
half-dose t-PA versus no fibrinolysis
MOPETT, 2012	half-dose thrombolysis versus standard regimen of anticoagulants alone	patients presenting with moderate PE	open Follow-up duration: 28 months
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 embolism	double-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 DVT	open (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 DVT	open 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 embolism	open 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 thrombosis	open Follow-up duration: 9.8 months 38 countries
rt-PA versus no fibrinolysis
PAIMS 2, 1992	rt-PA 100 mg IV over 2 h and heparin versus Heparin 1750 IU/hr i.v. for 7 to 10 days	patients with angiographically documented pulmonary embolism	open Follow-up duration: 7 days Italy
Goldhaber, 1993	rt-PA 100 mg IV over 2 h then 1000 U/hr heparin,when PTT or TT was < 2 times control. Subsequent heparin dose achieved PTT = 1.5 to 2.5 times the upperlimit of normal. versus heparin, initial dose 5000 U bolus followed by 1000 U/hr continuous i.v., 4 hr after the dose of heparin according to PTT. Target PTT = 1.5 to 2.5 times of normal	haemodynamically stable patients with acute pulmonary embolism	open Follow-up duration: 14 days US
rt-PA versus placebo
Konstantinides, 2002	100 mg alteplase given as 10 mg bolus followed by 90 mg i.v. infusion over 2 hours then i.v. heparin 1000 U/hr adjusted to maintain APTT of 2.0 to 2.5times the upper normal limit. Oral anticoagulation was started on day 3 versus placebo + i.v. heparin 1000 U/hr adjusted to maintain APTT of 2.0 to 2.5times the upper normal limit. Oral anticoagulation was started on day 3	patients with acute pulmonary embolism and pulmonary hypertensionor right ventricular dysfunction but withoutarterial hypotension or shock	double blind Follow-up duration: <30 days Germany
PIOPED, 1990	rt-PA 40–80 mg IV over 90 min plus heparin versus placebo+heparin	patients with acute pulmonary embolism	double blind Follow-up duration: 7 days US
Levine, 1990	rt-PA 0.6 mg/kg IV over 2 min and heparin, initial bolus of 5000 U, then 30,000 U for first 24 hr continuous infusion,only interrupted for the duration of the study drug infusion versus placebo + heparin bolus of 5000 U, then 30,000 U for first 24 hr continuous infusion	patients with objectively established acute symptomatic pulmonary embolism	double blind Follow-up duration: 10 days Canada
streptokinase versus no fibrinolysis
Tibbutt, 1974	intrapulmonary SK 600,000-U bolus, then 100,000 U/h for 72 h and intrapulmonary heparin versus 5000U heparin plus 100mg hydrocortisone infused over 30 mins through pulmonary artery catheter. Followed by 2500 U for 72 hr	life-threatening pulmonary embolism	open Follow-up duration: 3 days UK
Ly, 1978	streptokinase 250,000-U bolus, then 100,000 U/h for 72 h and heparin versus Heparin 15,000 IU initial dose i.v. followed by 30,000 IU/day continuous i.v., adjusted by TT	patients with major pulmonary embolism verified by angiography	open Follow-up duration: 10 days Norway
Jerjes-Sanchez, 1995	streptokinase 1,500,000 U IV over 1 h and heparin versus heparin alone	high clinical suspicion for massive pulmonary embolism	open Follow-up duration: 3 days
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 thrombosi	double 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 PE	open Follow-up duration: 3 mo
urokinase versus no fibrinolysis
Marini, 1988	urokinase 800,000 U/d IV for 72 h, UK 3,300,000 U IV for 12 h and heparin versus heparin	patients with pulmonary embolism	open Follow-up duration: 7 days
urokinase versus placebo
UPET, 1973	urokinase 2,000-U/lb bolus, then 2,000 U/lb per h IV for 12 h and heparin versus placebo + Heparin (a loading dose of 75 U/pound, then 10 U/pound/hr for 12 hr infusion, then heparin for a minimum of 5 days, followed by heparin or warfarin therapy for a total of 14 days)	patients with pulmonary embolism	double blind Follow-up duration: <14 days US