Comparative Investigation of Low Molecular Weight (LMW) Heparin/Edoxaban Tosylate (DU176b) Versus (LMW) Heparin/Warfarin in the Treatment of Symptomatic Deep-Vein Blood Clots and/or Lung Blood Clots. (The Edoxaban Hokusai-VTE Study).
Summary
Evaluation of heparin/edoxaban tosylate (DU176b) versus heparin/warfarin in preventing recurrence of blood clots in patients with acute symptomatic deep-vein blood clots in the legs and/or blood clots in the lungs.
Timeline
- Start
- 2009-10
- Primary completion
- 2013-04
- Completion
- 2013-04
Outcome
Met primary endpoint
registry p <0.0001; Hazard Ratio (HR) 0.89 (95% CI .703 to 1.128) NCT00986154 ↗
paper Edoxaban was noninferior to warfarin with respect to the primary efficacy outcome PMID 23991658 ↗
release “Once-daily edoxaban met the primary efficacy endpoint of non-inferiority for the treatment and prevention of VTE” daiichisankyo.com ↗
release “In Hokusai-VTE, SAVAYSA was shown to be non-inferior to warfarin for the primary endpoint of symptomatic recurrent VTE” daiichisankyo.com ↗
release “In the Hokusai-VTE study, once-daily edoxaban 60 mg was non-inferior to warfarin for the primary efficacy endpoint of recurrence of symptomatic VTE” daiichisankyo.com ↗
Publications
- Christodoulou KC, Barco S, Abele C, Lodigiani C, Monreal M, Konstantinides SV, Valerio L. Burden of Atherosclerosis and Outcomes of Acute Pulmonary Embolism: A Post Hoc Analysis of the Hokusai-VTE Trial. J Am Heart Assoc. 2025 Nov 18;14(22):e041420. doi: 10.1161/JAHA.125.041420. Epub 2025 Nov 6.
- Barco S, Abele C, Ageno W, Klok FA, Wenzel P, Trinchero A, Malcovati L, Konstantinides SV, Valerio L. Warfarin reduces circulating white blood cell count: Post-hoc analysis of two randomized trials. Thromb Res. 2025 Oct;254:109452. doi: 10.1016/j.thromres.2025.109452. Epub 2025 Sep 5.
- Vanassche T, Verhamme P, Wells PS, Segers A, Ageno W, Brekelmans MPA, Chen CZ, Cohen AT, Grosso MA, Medina AP, Mercuri MF, Winters SM, Zhang G, Weitz JI, Raskob GE, Buller HR. Impact of age, comorbidity, and polypharmacy on the efficacy and safety of edoxaban for the treatment of venous thromboembolism: An analysis of the randomized, double-blind Hokusai-VTE trial. Thromb Res. 2018 Feb;162:7-14. doi: 10.1016/j.thromres.2017.12.005. Epub 2017 Dec 13.
- Vandell AG, Walker J, Brown KS, Zhang G, Lin M, Grosso MA, Mercuri MF. Genetics and clinical response to warfarin and edoxaban in patients with venous thromboembolism. Heart. 2017 Nov;103(22):1800-1805. doi: 10.1136/heartjnl-2016-310901. Epub 2017 Jul 8.
- Brekelmans MP, Ageno W, Beenen LF, Brenner B, Buller HR, Chen CZ, Cohen AT, Grosso MA, Meyer G, Raskob G, Segers A, Vanassche T, Verhamme P, Wells PS, Zhang G, Weitz JI. Recurrent venous thromboembolism in patients with pulmonary embolism and right ventricular dysfunction: a post-hoc analysis of the Hokusai-VTE study. Lancet Haematol. 2016 Sep;3(9):e437-45. doi: 10.1016/S2352-3026(16)30080-1.
- Raskob GE, van Es N, Segers A, Angchaisuksiri P, Oh D, Boda Z, Lyons RM, Meijer K, Gudz I, Weitz JI, Zhang G, Lanz H, Mercuri MF, Buller HR; Hokusai-VTE investigators. Edoxaban for venous thromboembolism in patients with cancer: results from a non-inferiority subgroup analysis of the Hokusai-VTE randomised, double-blind, double-dummy trial. Lancet Haematol. 2016 Aug;3(8):e379-87. doi: 10.1016/S2352-3026(16)30057-6. Epub 2016 Jul 1.
- Nakamura M, Wang YQ, Wang C, Oh D, Yin WH, Kimura T, Miyazaki K, Abe K, Mercuri M, Lee LH, Segers A, Buller H. Efficacy and safety of edoxaban for treatment of venous thromboembolism: a subanalysis of East Asian patients in the Hokusai-VTE trial. J Thromb Haemost. 2015 Sep;13(9):1606-14. doi: 10.1111/jth.13055. Epub 2015 Aug 27.
- Hokusai-VTE Investigators; Buller HR, Decousus H, Grosso MA, Mercuri M, Middeldorp S, Prins MH, Raskob GE, Schellong SM, Schwocho L, Segers A, Shi M, Verhamme P, Wells P. Edoxaban versus warfarin for the treatment of symptomatic venous thromboembolism. N Engl J Med. 2013 Oct 10;369(15):1406-15. doi: 10.1056/NEJMoa1306638. Epub 2013 Aug 31.
- Camm AJ, Bounameaux H. Edoxaban: a new oral direct factor xa inhibitor. Drugs. 2011 Aug 20;71(12):1503-26. doi: 10.2165/11595540-000000000-00000.
Drugs
| Evaluation | Drug | Modality | Dose | Route |
|---|---|---|---|---|
| Subject | Edoxaban | Small molecule | 30 mg | Oral |
| Subject | Edoxaban | Small molecule | 60 mg | Oral |
| Comparator | Warfarin | Small molecule | 0.5 mg | Oral |
| Comparator | Warfarin | Small molecule | 1 mg | Oral |
| Comparator | Warfarin | Small molecule | 2.5 mg | Oral |
| Comparator | Warfarin | Small molecule | 5 mg | Oral |