AMPLIFY, 2013 trial summary    PDF trial summary

A randomised clinical trial investigating the effect of apixaban (without LMWH) versus LMWH/VKA in patients with deep vein thrombosis or pulmonary embolism

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NCT00643201    N Engl J Med 2013 Aug 29;369:799-808  
DOAC without heparin



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
Age 56.95
female (%) xxx



Patients patients with deep vein thrombosis or pulmonary embolism
Group sizes2691 / 2704
Exclusion criteriacontraindications 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
Time from onset of symptoms
cancer (%)
Immobilization (%)
Surgery or trauma (%)



Blindness double blind Inclusion period Aug 2008 -
Follow-up duration 6 mo Centers
Lost to FU geographical localisation
Primary endpoint Venous thromboembolic recurrence or death Design Parallel groups
PeriodeInclusionAug 2008 -



EndpointX1N1X0N0TE95% CI Major bleeding 15 2676 49 2689 0,31[0,17; 0,55] coronary events - 4816 - 0 no data All deaths 41 2676 52 2689 0,79[0,52; 1,20] fatal PE 1 2609 2 2635 0,50[0,05; 5,57] recurrent VTE during treatment 59 2609 71 2635 0,84[0,59; 1,19] non fatal PE 27 2609 23 2635 1,19[0,68; 2,07] Symptomatic deep-vein thrombosis 20 2609 33 2635 0,61[0,35; 1,07] recurrent DVT only 20 2609 33 2635 0,61[0,35; 1,07] Symptomatic nonfatal pulmonary embolism 27 2609 23 2635 1,19[0,68; 2,07] recurrent VTE 59 2609 71 2635 0,84[0,59; 1,19] death 41 2676 52 2689 0,79[0,52; 1,20] Death related to venous thromboembolism 11 2609 13 2635 0,85[0,38; 1,91] net clinical benefit - 2691 - 2704 no data any bleeding - 4816 - 0 no data major or clinically relevant nonmajor bleeding - 2691 - 2704 no data0,22,01,0

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     [PMID: 23808982]   link to pdf   add to Mendeley  

Links

NEJM

ClinicalTrial.gov record NCT00643201



Registering number NCT00643201 (see trial on clinicaltrials.gov)
Code Name CV185-056