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.
The classical management of patients with venous thromboembolism (VTE) consists of an initial treatment of at least five days of a (LMW) heparin followed by long-term treatment with a vitamin K antagonist (VKA), such as warfarin. The eTRIS study will address the clinically important question of whether edoxaban monotherapy, without concomitant (LMW) heparin at the time of treatment initiation is comparable to or better than standard treatment with (LMW) heparin/warfarin therapy in subjects with acute symptomatic DVT as assessed by the relative change from baseline in thrombus volume (measured by MRI) at Day 14-21.
Study Type
INTERVENTIONAL
Allocation
RANDOMIZED
Purpose
TREATMENT
Masking
NONE
Enrollment
85
edoxaban tosylate (DU-176b), film-coated for oral use, 90 mg once daily (QD) for 10 days (±2 days) followed by 60 mg QD for a total of approximately 90 days of edoxaban treatment
enoxaparin - administered by subcutaneous injection;1 mg/kg/ twice daily or 1.5 mg/kg once daily unfractionated heparin - started with 5000 IU bolus intravenous administration, 1300 IU/h continuous infusion, minimum of 5 days of treatment and stopped when target INR (2.0 - 3.0) is achieved.
tablet for oral use; daily dosage, adjusted to maintain international normalized ratio (INR) between 2.0 and 3.0; 90 days treatment.
Unnamed facility
Dothan, Alabama, United States
Unnamed facility
Montgomery, Alabama, United States
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Sacramento, California, United States
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Atlantis, Florida, United States
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Clearwater, Florida, United States
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Fort Myers, Florida, United States
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Jacksonville, Florida, United States
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Sarasota, Florida, United States
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Tampa, Florida, United States
Unnamed facility
Jonesboro, Georgia, United States
...and 24 more locations
Relative Change From Baseline in Thrombus Volume Assessed by MRI [Using the Magnetic Resonance Venography (MRV) Method]
Thrombus Volume (mm\^3) was measured at baseline and between days 14 to 21 using MRI results as determined by Magnetic Resonance Venography (MRV) method, and the relative percentage change from baseline was calculated
Time frame: Baseline to final visit (Day 14-21)
Number of Participants With Clinically Relevant Bleeding
Clinically relevant bleeding was defined as major or clinically relevant non-major bleeding
Time frame: Initial dose of study drug up to 3 days after last dose
Number of Participants With Recurrence of Venous Thromboembolism (VTE)
Number of participants with investigator-confirmed recurrent VTE events that start or worsen after the first dose of study drug and prior to the date of the final visit or telephone contact (inclusive)
Time frame: Baseline to final visit (Day 14-21)
Number of Participants With Major Adverse Cardiovascular Events (MACE)
MACE is defined as a composite of non-fatal myocardial infarction (MI), non-fatal stroke, non-fatal systemic embolic event (SEE) and cardiovascular death
Time frame: Initial dose of study drug up to 3 days after last dose
Number of Participants With Change From Baseline in the Presence or Absence of Thrombus by Vessel
Time frame: Baseline to final visit (Day 14-21)
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