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Deep Vein ThrombosisPhase 2eTRISNCT01662908

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

A Phase 2 study testing edoxaban tosylate, enoxaparin/unfractionated heparin and warfarin in people with Deep Vein Thrombosis and Venous Thrombosis, run by Daiichi Sankyo at 34 sites in 2 countries.

Completed

Finished. The study has ended and is not enrolling. Results may be posted on the official record.

Official record
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Trial 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. Read more about this study

Who is it for?
Ages 18 years and older
Conditions the study is for
Deep Vein Thrombosis, Venous Thrombosis
What is being tested?
edoxaban tosylate, enoxaparin/unfractionated heparin and warfarin
Could I receive a placebo?
No, everyone receives an active treatment
How many people
85 participants
Where
34 sitesin 2 countries
Study dates
Aug 2012to Mar 2014
Phase
Phase 2
Are there results?
Yes, posted in the registrySummary in the doctors' view

Key requirements

Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.

  • Ages 18 years and older
  • All sexes
  • No healthy volunteers
  • Adult, Older adult

Who may be able to join

  • Male or female subjects older than the minimum legal adult age (country specific)
  • 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
  • Able to provide signed informed consent

Who cannot join

  • Concomitant pulmonary embolism known to the investigator at the time of randomization
  • Thrombectomy, insertion of a caval filter, or use of a fibrinolytic agent to treat the current episode of DVT
  • Indication for warfarin other than DVT
  • More than 48 hours pre-treatment with therapeutic dosages of anti-coagulant treatment [low molecular weight heparin (LMWH), unfractionated heparin (UFH), fondaparinux, VKA, factor Xa inhibitor or other anti coagulant per local labeling] prior to randomization to treat the current episode
  • Treatment with any investigational drug within 30 days prior to randomization
  • Calculated creatinine clearance (CrCL) < 30 mL/min
Show all 20Show fewer
  • Significant liver disease (e.g., acute hepatitis, chronic active hepatitis, cirrhosis) or alanine aminotransferase (ALT) > or = 2 times the upper limit of normal (ULN), or total bilirubin (TBL) > or = to 1.5 times the ULN (however subjects whose elevated TBL is due to known Gilbert's syndrome may be included in the study)
  • Subjects with active cancer for whom long term treatment with (LMW) heparin is anticipated
  • Life expectancy < 3 months
  • Active bleeding or high risk for bleeding contraindicating treatment with (LMW) heparin or warfarin
  • Uncontrolled hypertension as judged by the Investigator (e.g., systolic blood pressure > 170 mmHg or diastolic blood pressure > 100 mmHg despite antihypertensive medications confirmed by repeat measurement)
  • Women of childbearing potential without proper contraceptive measures (i.e., a method of contraception with a failure rate < 1 % during the course of the study including the observational period) and women who are pregnant or breast feeding
  • Any contraindication listed in the local labeling of LMWH, UFH, or warfarin
  • 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.
  • Treatment with aspirin in a dosage of more than 100 mg/per day or dual antiplatelet therapy (any two antiplatelet agents including aspirin plus any other oral or intravenous [IV] antiplatelet drug) anticipated to continue during the study
  • Treatment with P-gp inhibitors is not permitted at the time of randomization; subsequent use is permitted, with a dose reduction in the edoxaban monotherapy treatment arm.
  • Known history of positive Hepatitis B antigen or Hepatitis C antibody
  • Subjects with any condition that, as judged by the investigator, would put the subject at increased risk of harm if he/she participated in the study; including, but not limited to, subjects at increased risk of harm if given a gadolinium-based contrast agent such as gadofosveset trisodium (Ablavar®)
  • Subjects for whom MRI would be contraindicated (e.g., subjects with metal implants) or for whom the use of a gadolinium-based contrast agent such as gadofosveset trisodium (Ablavar®) would be contraindicated
  • Subject has previously entered this study or another edoxaban study

Trial locations and contacts

34 sites in 2 countries.

34 sites in 2 countries

United States29 sites

  • Study site

    Annapolis, Maryland

  • Study site

    Atlantis, Florida

  • Study site

    Baltimore, Maryland

  • Study site

    Butte, Montana

  • Study site

    Camp Hill, Pennsylvania

  • Study site

    Clearwater, Florida

  • Study site

    Covington, Louisiana

  • Study site

    Dothan, Alabama

  • Study site

    Durham, North Carolina

  • Study site

    Ephrata, Pennsylvania

  • Study site

    Fort Myers, Florida

  • Study site

    Fredericksburg, Virginia

  • Study site

    Grand Island, Nebraska

  • Study site

    Greensboro, North Carolina

  • Study site

    Jacksonville, Florida

  • Study site

    Jonesboro, Georgia

  • Study site

    Lafayette, Indiana

  • Study site

    Maumee, Ohio

  • Study site

    Montgomery, Alabama

  • Study site

    Paducah, Kentucky

  • Study site

    Randallstown, Maryland

  • Study site

    Rapid City, South Dakota

  • Study site

    Rochester, New York

  • Study site

    Sacramento, California

  • Study site

    Sarasota, Florida

  • Study site

    Sellersville, Pennsylvania

  • Study site

    Tacoma, Washington

  • Study site

    Tampa, Florida

  • Study site

    Wilmington, North Carolina

Other trials in United States

Canada5 sites

  • Study site

    Edmonton, Alberta

  • Study site

    Greenfield Park, Quebec

  • Study site

    London, Ontario

  • Study site

    Montreal, Quebec

  • Study site

    Newmarket, Ontario

Other trials in Canada

About this study

Official title: A 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

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.

Read the detailed description

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.

Being tested
edoxaban tosylate, enoxaparin/unfractionated heparin, warfarin
Medical subject headings
Venous Thrombosis

What participants receive

What participants receive. In a randomised study each person is assigned to one group by chance.

  • edoxaban tosylateDrug

    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/unfractionated heparinDrug

    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.

  • warfarinDrug

    tablet for oral use; daily dosage, adjusted to maintain international normalized ratio (INR) between 2.0 and 3.0; 90 days treatment.

Study groups in NCT01662908
Study groupRoleWhat they receive
edoxaban tosylateExperimentalNot described
Receives: Drug: edoxaban tosylate
heparin/warfarinActive comparatorNot described
Receives: Drug: enoxaparin/unfractionated heparin; Drug: warfarin

What is being measured

The primary outcome is the main question the study is designed to answer.

  1. 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

    Measured: Baseline to final visit (Day 14-21)

Secondary outcomes (4)

  1. Number of Participants With Clinically Relevant Bleeding

    Clinically relevant bleeding was defined as major or clinically relevant non-major bleeding

    Measured: Initial dose of study drug up to 3 days after last dose

  2. 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)

    Measured: Baseline to final visit (Day 14-21)

  3. 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

    Measured: Initial dose of study drug up to 3 days after last dose

  4. Number of Participants With Change From Baseline in the Presence or Absence of Thrombus by Vessel

    Measured: Baseline to final visit (Day 14-21)

Timeline

From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.

  1. First posted13 Aug 2012 (estimated)
  2. Study startAug 2012
  3. Primary completionJan 2014
  4. Study completionMar 2014

Resources

More details

For doctors and researchers: how the study is designed, who runs it, and its registry IDs.

Study design
Study type
Interventional
Phase
Phase 2
Primary purpose
Treatment
Allocation
Randomised
Intervention model
Parallel groups
Masking
None (open label)
Enrolment
85 participants (actual)
IDs, dates and publications
ClinicalTrials.gov ID
NCT01662908
Sponsor's protocol ID
DU176b-D-U211
Acronym
eTRIS
Status last verified
May 2017
First submitted
2 Aug 2012
Last updated
26 Feb 2019
Data monitoring committee
No
Individual data sharing
Yes: De-identified individual participant data (IPD) and applicable supporting clinical trial documents may be available upon request at https://vivli.org/. In cases where clinical trial data and supporting documents are provided pursuant to our company policies and procedures, Daiichi Sankyo will continue to protect the privacy of our clinical trial participants. Details on data sharing criteria and the procedure for requesting access can be found at this web address: https://vivli.org/ourmember/daiichi-sankyo/

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.

    PubMed 27165711

Questions about this trial

What is this clinical trial studying?

A Phase 2 study testing edoxaban tosylate, enoxaparin/unfractionated heparin and warfarin in people with Deep Vein Thrombosis and Venous Thrombosis, run by Daiichi Sankyo at 34 sites in 2 countries.

The full registered description is in the About this study section and the official record.

Who may be eligible to take part?

The sponsor lists 3 inclusion and 20 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.

Is this clinical trial currently recruiting?

The record says: finished, as of the sponsor's last update on 26 Feb 2019. Status can change between updates, so confirm with the study contact before making plans.

Where is the study taking place?

The record lists 34 sites in United States, Canada. Whether a site is taking part right now should be confirmed with that site. See every site.

What are the possible benefits and risks?

They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.

What does this phase mean?

Phase 2 studies give the treatment to a larger group to see whether it has the intended effect and to keep checking safety.

Not every study follows the same path, and some studies (observational studies, device studies) have no phase.

Are results available for this study?

Yes. Results are posted in the registry (first posted 12 May 2017). A summary is in the For doctors view, and the full results are on ClinicalTrials.gov.

How can a doctor refer a patient or contact the research team?

The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.

What does the primary outcome measure?

Relative Change From Baseline in Thrombus Volume Assessed by MRI [Using the Magnetic Resonance Venography (MRV) Method] (time frame: Baseline to final visit (Day 14-21)). It is what the study was designed to measure, not a finding.

Where can I read the original study information?

On the ClinicalTrials.gov record for NCT01662908, which also lists 1 linked publication.

Does a listing mean the treatment is approved or proven to work?

No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.

How often is this information updated?

AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 26 Feb 2019.

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