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Trial record 1 of 2 for:    eTRIS
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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 (eTRIS)

This study has been completed.
Sponsor:
ClinicalTrials.gov Identifier:
NCT01662908
First Posted: August 13, 2012
Last Update Posted: June 8, 2017
The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details.
Information provided by (Responsible Party):
Daiichi Sankyo, Inc.
August 2, 2012
August 13, 2012
September 28, 2016
May 12, 2017
June 8, 2017
August 2012
January 2014   (Final data collection date for 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) ]
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
Relative change from baseline in thrombus volume assessed by MRI [ Time Frame: 14 - 21 days from time of randomization ]
Complete list of historical versions of study NCT01662908 on ClinicalTrials.gov Archive Site
  • Number of Participants With Clinically Relevant Bleeding [ Time Frame: Initial dose of study drug up to 3 days after last dose ]
    Clinically relevant bleeding was defined as major or clinically relevant non-major bleeding
  • Number of Participants With Recurrence of Venous Thromboembolism (VTE) [ Time Frame: Baseline to final visit (Day 14-21) ]
    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)
  • Number of Participants With Major Adverse Cardiovascular Events (MACE) [ Time Frame: Initial dose of study drug up to 3 days after last dose ]
    MACE is defined as a composite of non-fatal myocardial infarction (MI), non-fatal stroke, non-fatal systemic embolic event (SEE) and cardiovascular death
  • 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) ]
  • Clinically relevant bleeding (i.e., major or clinically relevant non-major bleeding) [ Time Frame: From Day 1 Visit to Day 10 Visit, and during treatment up to 3 days after interrupting or stopping study drug ]
  • Recurrence of VTE [ Time Frame: 90 days from time of randomization ]
  • Major adverse cardiovascular events (MACE) defined as a composite of non-fatal myocardial infarction (MI), non-fatal stroke, non-fatal systemic embolic event (SEE) and cardiovascular death. [ Time Frame: 90 days from time of randomization ]
  • Change from baseline in the presence or absence of thrombus by vessel [ Time Frame: 14 - 21 days from time of randomization ]
Not Provided
Not Provided
 
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 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.
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.
Interventional
Phase 2
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: None (Open Label)
Primary Purpose: Treatment
  • Deep Vein Thrombosis
  • Venous Thrombosis
  • Drug: edoxaban tosylate
    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
  • Drug: enoxaparin/unfractionated heparin
    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.
  • Drug: warfarin
    tablet for oral use; daily dosage, adjusted to maintain international normalized ratio (INR) between 2.0 and 3.0; 90 days treatment.
  • Experimental: edoxaban tosylate
    Intervention: Drug: edoxaban tosylate
  • Active Comparator: heparin/warfarin
    Interventions:
    • Drug: enoxaparin/unfractionated heparin
    • Drug: warfarin
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.

*   Includes publications given by the data provider as well as publications identified by ClinicalTrials.gov Identifier (NCT Number) in Medline.
 
Completed
85
March 2014
January 2014   (Final data collection date for primary outcome measure)

Inclusion Criteria:

  • 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

Exclusion Criteria:

  • 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
  • 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
Sexes Eligible for Study: All
18 Years and older   (Adult, Senior)
No
Contact information is only displayed when the study is recruiting subjects
Canada,   United States
 
 
NCT01662908
DU176b-D-U211
No
Not Provided
Not Provided
Daiichi Sankyo, Inc.
Daiichi Sankyo, Inc.
Not Provided
Principal Investigator: Samuel Z Goldhaber, MD Brigham and Women's Hospital
Daiichi Sankyo, Inc.
May 2017

ICMJE     Data element required by the International Committee of Medical Journal Editors and the World Health Organization ICTRP