--- title: 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 nct_id: NCT01662908 overall_status: COMPLETED phase: PHASE2 sponsor: Daiichi Sankyo study_type: INTERVENTIONAL primary_condition: Deep Vein Thrombosis countries: United States, Canada canonical_url: "https://parkinsonspathways.com/agent/trials/NCT01662908.md" clinicaltrials_gov: "https://clinicaltrials.gov/study/NCT01662908" ct_last_update_post_date: 2019-02-26 last_seen_at: "2026-05-12T06:01:06.704Z" source: ClinicalTrials.gov (mirrored, no enrichment) --- # 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 **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 **NCT ID:** [NCT01662908](https://clinicaltrials.gov/study/NCT01662908) ## Key Facts - **Status:** COMPLETED - **Phase:** PHASE2 - **Study Type:** INTERVENTIONAL - **Target Enrollment:** 85 - **Lead Sponsor:** Daiichi Sankyo - **Conditions:** Deep Vein Thrombosis, Venous Thrombosis - **Start Date:** 2012-08 - **Completion Date:** 2014-03 - **CT.gov Last Update:** 2019-02-26 ## Brief 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. ## 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. ## Eligibility - **Minimum age:** 18 Years - **Sex:** ALL - **Healthy Volunteers:** No ``` 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 ``` ## Arms - **edoxaban tosylate** (EXPERIMENTAL) - **heparin/warfarin** (ACTIVE_COMPARATOR) ## Interventions - **edoxaban tosylate** (DRUG) — 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 heparin** (DRUG) — 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. - **warfarin** (DRUG) — tablet for oral use; daily dosage, adjusted to maintain international normalized ratio (INR) between 2.0 and 3.0; 90 days treatment. ## Primary Outcomes - **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 ## Secondary Outcomes - **Number of Participants With Clinically Relevant Bleeding** _(time frame: Initial dose of study drug up to 3 days after last dose)_ - **Number of Participants With Recurrence of Venous Thromboembolism (VTE)** _(time frame: Baseline to final visit (Day 14-21))_ - **Number of Participants With Major Adverse Cardiovascular Events (MACE)** _(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))_ ## Locations (34) - Dothan, Alabama, United States - Montgomery, Alabama, United States - Sacramento, California, United States - Atlantis, Florida, United States - Clearwater, Florida, United States - Fort Myers, Florida, United States - Jacksonville, Florida, United States - Sarasota, Florida, United States - Tampa, Florida, United States - Jonesboro, Georgia, United States - Lafayette, Indiana, United States - Paducah, Kentucky, United States - Covington, Louisiana, United States - Annapolis, Maryland, United States - Baltimore, Maryland, United States - Randallstown, Maryland, United States - Butte, Montana, United States - Grand Island, Nebraska, United States - Rochester, New York, United States - Durham, North Carolina, United States - Greensboro, North Carolina, United States - Wilmington, North Carolina, United States - Maumee, Ohio, United States - Camp Hill, Pennsylvania, United States - Ephrata, Pennsylvania, United States - Sellersville, Pennsylvania, United States - Rapid City, South Dakota, United States - Fredericksburg, Virginia, United States - Tacoma, Washington, United States - Edmonton, Alberta, Canada - London, Ontario, Canada - Newmarket, Ontario, Canada - Greenfield Park, Quebec, Canada - Montreal, Quebec, Canada ## Recent Field Changes (last 30 days) - `locations.|sacramento|california|united states` — added _(2026-05-12)_ - `locations.|atlantis|florida|united states` — added _(2026-05-12)_ - `locations.|clearwater|florida|united states` — added _(2026-05-12)_ - `locations.|fort myers|florida|united states` — added _(2026-05-12)_ - `locations.|jacksonville|florida|united states` — added _(2026-05-12)_ - `status.overallStatus` — added _(2026-05-12)_ - `status.primaryCompletionDate` — added _(2026-05-12)_ - `status.completionDate` — added _(2026-05-12)_ - `status.lastUpdatePostDate` — added _(2026-05-12)_ - `design.phases` — added _(2026-05-12)_ - `design.enrollmentCount` — added _(2026-05-12)_ - `eligibility.criteria` — added _(2026-05-12)_ - `eligibility.minAge` — added _(2026-05-12)_ - `eligibility.sex` — added _(2026-05-12)_ - `outcomes.primary` — added _(2026-05-12)_ - `outcomes.secondary` — added _(2026-05-12)_ - `armsInterventions.arms` — added _(2026-05-12)_ - `armsInterventions.interventions` — added _(2026-05-12)_ - `sponsor.lead` — added _(2026-05-12)_ - `results.hasResults` — added _(2026-05-12)_ - `locations.|dothan|alabama|united states` — added _(2026-05-12)_ - `locations.|montgomery|alabama|united states` — added _(2026-05-12)_ - `locations.|sarasota|florida|united states` — added _(2026-05-12)_ - `locations.|tampa|florida|united states` — added _(2026-05-12)_ - `locations.|jonesboro|georgia|united states` — added _(2026-05-12)_ - `locations.|lafayette|indiana|united states` — added _(2026-05-12)_ - `locations.|paducah|kentucky|united states` — added _(2026-05-12)_ - `locations.|covington|louisiana|united states` — added _(2026-05-12)_ - `locations.|annapolis|maryland|united states` — added _(2026-05-12)_ - `locations.|baltimore|maryland|united states` — added _(2026-05-12)_ - `locations.|randallstown|maryland|united states` — added _(2026-05-12)_ - `locations.|butte|montana|united states` — added _(2026-05-12)_ - `locations.|grand island|nebraska|united states` — added _(2026-05-12)_ - `locations.|rochester|new york|united states` — added _(2026-05-12)_ - `locations.|durham|north carolina|united states` — added _(2026-05-12)_ - `locations.|greensboro|north carolina|united states` — added _(2026-05-12)_ - `locations.|wilmington|north carolina|united states` — added _(2026-05-12)_ - `locations.|maumee|ohio|united states` — added _(2026-05-12)_ - `locations.|camp hill|pennsylvania|united states` — added _(2026-05-12)_ - `locations.|ephrata|pennsylvania|united states` — added _(2026-05-12)_ - `locations.|sellersville|pennsylvania|united states` — added _(2026-05-12)_ - `locations.|rapid city|south dakota|united states` — added _(2026-05-12)_ - `locations.|fredericksburg|virginia|united states` — added _(2026-05-12)_ - `locations.|tacoma|washington|united states` — added _(2026-05-12)_ - `locations.|edmonton|alberta|canada` — added _(2026-05-12)_ - `locations.|london|ontario|canada` — added _(2026-05-12)_ - `locations.|newmarket|ontario|canada` — added _(2026-05-12)_ - `locations.|greenfield park|quebec|canada` — added _(2026-05-12)_ - `locations.|montreal|quebec|canada` — added _(2026-05-12)_ --- *Canonical: https://parkinsonspathways.com/agent/trials/NCT01662908.md* *Source data (authoritative): https://clinicaltrials.gov/study/NCT01662908* *This page is a raw mirror with no AI summary, no editorial enrichment, and no Parkinson's-specific filtering.*