A Randomized, Open-Label, Parallel-Group, Multi-Center Study for the Evaluation of Efficacy and Safety of Edoxaban Monotherapy Versus Low Molecular Weight (LMW) Heparin/Warfarin in Subjects With Symptomatic Deep-Vein Thrombosis

Phase 2 Completed 85 enrolled Daiichi Sankyo

RandomizedParallel-groupOpen-labelTreatment

Summary

Assess the relative change in thrombus volume as determined by two assessments (Baseline and Day 14-21) with magnetic resonance venography (MRV) in subjects with deep-vein thrombosis (DVT) treated with either an edoxaban monotherapy regimen or a low molecular weight (LMW) heparin/warfarin regimen.

Timeline

Start: 2012-08
Primary completion: 2014-01
Completion: 2014-03

Publications

Piazza G, Mani V, Goldhaber SZ, Grosso MA, Mercuri M, Lanz HJ, Schussler S, Hsu C, Chinigo A, Ritchie B, Nadar V, Cannon K, Pullman J, Concha M, Schul M, Fayad ZA; edoxaban Thrombus Reduction Imaging Study (eTRIS) Investigators. Magnetic resonance venography to assess thrombus resolution with edoxaban monotherapy versus parenteral anticoagulation/warfarin for symptomatic deep vein thrombosis: A multicenter feasibility study. Vasc Med. 2016 Aug;21(4):361-8. doi: 10.1177/1358863X16645853. Epub 2016 May 10.

Drugs

Evaluation	Drug	Modality	Dose	Route
Subject	Edoxaban	Small molecule	60 mg	Oral
Subject	Edoxaban	Small molecule	90 mg	Oral
Comparator	Enoxaparin sodium	Other / unclassified	1 mg/kg	Subcutaneous
Comparator	Enoxaparin sodium	Other / unclassified	1.5 mg/kg	Subcutaneous
Comparator	Heparin	Other / unclassified	1300 iu	Intravenous
Comparator	Warfarin	Small molecule	—	Oral

A Randomized, Open-Label, Parallel-Group, Multi-Center Study for the Evaluation of Efficacy and Safety of Edoxaban Monotherapy Versus Low Molecular Weight (LMW) Heparin/Warfarin in Subjects With Symptomatic Deep-Vein Thrombosis

Summary

Timeline

Publications

Drugs

Indications