Completed

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

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What is being tested

edoxaban tosylate

+ enoxaparin/unfractionated heparin

+ warfarin

Drug
Who is being recruted

Cardiovascular Diseases+2

+ Thrombosis

+ Vascular Diseases

Over 18 Years
+23 Eligibility Criteria
See all eligibility criteria
How is the trial designed

Treatment Study

Phase 2
Interventional
Study Start: August 2012
See protocol details

Summary

Principal SponsorDaiichi Sankyo
Last updated: February 26, 2019
Sourced from a government-validated database.Claim as a partner

Study start date: August 1, 2012

Actual date on which the first participant was enrolled.

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.

NCT01662908
Principal SponsorDaiichi Sankyo
Last updated: February 26, 2019
Sourced from a government-validated database.Claim as a partner

Protocol

This section provides details of the study plan, including how the study is designed and what the study is measuring.
Design Details

85 patients to be enrolled

Total number of participants that the clinical trial aims to recruit.

Treatment Study

These studies test new ways to treat a disease, condition, or health issue. The goal is to see if a new drug, therapy, or approach works better or has fewer side effects than existing options.

Eligibility

Researchers look for people who fit a certain description, called eligibility criteria: person's general health condition or prior treatments.
Conditions
Criteria

Any sex

Biological sex of participants that are eligible to enroll.

Over 18 Years

Range of ages for which participants are eligible to join.

Healthy volunteers not allowed

If individuals who are healthy and do not have the condition being studied can participate.

Conditions

Pathology

Cardiovascular DiseasesThrombosisVascular DiseasesEmbolism and ThrombosisVenous Thrombosis

Criteria

3 inclusion criteria required to participate
Able to provide signed informed consent
Acute symptomatic proximal DVT involving the popliteal, femoral or iliac veins confirmed by compression ultrasonography (CUS) or other appropriate imaging techniques (such as venography or spiral/contrast CT) with symptom onset < or = 1week prior to randomization
Male or female subjects older than the minimum legal adult age (country specific)
20 exclusion criteria prevent from participating
Active bleeding or high risk for bleeding contraindicating treatment with (LMW) heparin or warfarin
Any contraindication listed in the local labeling of LMWH, UFH, or warfarin
Calculated creatinine clearance (CrCL) < 30 mL/min
Chronic treatment with non-aspirin non-steroidal anti-inflammatory drugs (NSAIDs) including both cyclooxygenase-1 (COX-1) and cyclooxygenase-2 (COX- 2) inhibitors for > or = 4 days/week anticipated to continue during the study
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Study Plan

Find out more about all the medication administered in this study, their detailed description and what they involve.
Treatment Groups
Study Objectives

2 intervention groups are designated in this study

This study does not include a placebo group 

Treatment Groups

Group I

Experimental

Group II

Active Comparator

Study Objectives

Primary Objectives

Secondary Objectives

Study Centers

These are the hospitals, clinics, or research facilities where the trial is being conducted. You can find the location closest to you and its status.

This study has 34 locations

Dothan, United StatesOpen in Google Maps

Montgomery, United States

Sacramento, United States

Atlantis, United States
Completed34 Study Centers