APEX, 2016 trial summary    PDF trial summary

A randomised clinical trial investigating the effect of betrixaban versus enoxaparin in

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NCT01583218    N Engl J Med 2016 May 27;:  



Studied treatment betrixaban (at a dose of 80 mg once daily) for 35 to 42 days
Control treatment subcutaneous enoxaparin (at a dose of 40 mg once daily) for 10±4 days



Patients
Group sizes3759 / 3754
DVT diagnosis
PE diagnosis



Blindness double-blind Inclusion period
Follow-up duration Centers
Lost to FU geographical localisation
Primary endpoint asymptomatic proximal deep-vein thrombosis and symptomatic venous thromboembolism Design



EndpointX1N1X0N0TE95% CI VTE 132 1914 166 1956 0,81[0,64; 1,03] fatal PE - -9 - -9 no data proximal deep-vein thrombosis 132 3759 166 3754 0,79[0,63; 1,00] Venous thromboembolism or death 132 1914 166 1956 0,81[0,64; 1,03] DVT - -9 - -9 no data PE - -9 - -9 no data Symptomatic deep vein thrombosis during follow-up - -9 - -9 0,81[0,65; 1,00] Symptomatic pulmonary embolism during follow-up 132 3759 166 3754 0,79[0,63; 1,00] Major bleeding during follow-up - -9 - -9 1,19[0,67; 2,12] All-cause death during follow-up - -9 - -9 no data Asymptomatic deep vein thrombosis during follow-up. - -9 - -9 no data net clinical benefit 141 1914 174 1956 0,83[0,66; 1,04] Clinically relevant bleeding - -9 - -9 no data0,22,01,0

Cohen AT, Harrington RA, Goldhaber SZ, Hull RD, Wiens BL, Gold A, Hernandez AF, Gibson CM Extended Thromboprophylaxis with Betrixaban in Acutely Ill Medical Patients. N Engl J Med 2016;:     [PMID: 27232649]   link to pdf   add to Mendeley  

Cohen AT, Harrington RA, Goldhaber SZ, Hull RD, Wiens BL, Gold A, Hernandez AF, Gibson CM Extended Thromboprophylaxis with Betrixaban in Acutely Ill Medical Patients. N Engl J Med 2016 May 27;:     [PMID: 27232649]   link to pdf   add to Mendeley  

ClinicalTrial.gov record NCT01583218



Registering number NCT01583218 (see trial on clinicaltrials.gov)
Code Name