Hokusai-VTE Cancer, 2017 trial summary

A randomised clinical trial investigating the effect of edoxaban versus dalteparin in patients with cancer who had acute symptomatic or incidental venous thromboembolism

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NCT02073682    N Engl J Med 2018;378:615-624  



Studied treatment low-molecular-weight heparin for at least 5 days followed by oral edoxaban at a dose of 60 mg once daily. Treatment was given for atleast 6 months and up to 12 months.
Control treatment subcutaneous dalteparin at a dose of 200 IU per kilogram of body weight once daily for 1 month followed by dalteparin at a dose of 150 IU per kilogram once daily



Patients patients with cancer who had acute symptomatic or incidental venous thromboembolism
Group sizes522 / 524



Blindness open label Inclusion period
Follow-up duration Centers
Lost to FU geographical localisation
Primary endpoint recurrent venous thromboembolism or major bleeding at12 months Design



EndpointX1N1X0N0TE95% CI recurrent venous thromboembolism or major bleeding 67 522 71 524 0,97[0,70; 1,35] recurrent VTE - 522 - 524 0,71[0,48; 1,06] Major hemorrhage - 522 - 524 1,77[1,03; 3,04] Thrombocytopenia - 522 - 524 no data deaths at 6 months - 522 - 524 no data Recurrent DVT/DVTextension (total) - 522 - 524 no data Fatal hemorrhage - 522 - 524 no data all bleeding - 522 - 524 no data fatal PE - 522 - 524 no data Recurrent DVT/DVT extension (symptomatic) - 522 - 524 0,71[0,48; 1,06] All-cause mortality - 522 - 524 1,12[0,92; 1,37] death at 3 months - 522 - 524 no data non fatal PE - 522 - 524 no data0,22,01,0

Raskob GE Edoxaban for the Treatment of Cancer-Associated Venous Thromboembolism. N Engl J Med 2018;378:615-624     [PMID: 29231094]   link to pdf   add to Mendeley  

ClinicalTrial.gov record NCT02073682



Registering number NCT02073682 (see trial on clinicaltrials.gov)
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