Phase 2
N=84
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
Deep Vein Thrombosis · Venous Thrombosis
Bottom Line
View on ClinicalTrials.gov: NCT01662908 ↗Enrolled (actual)
84
Serious AEs
9.5%
Results posted
May 2017
Primary outcome: Primary: Relative Change From Baseline in Thrombus Volume Assessed by MRI [Using the Magnetic Resonance Venography (MRV) Method] — -46.6; -51.4 percentage of change
Study Design & Population
- Study type
- Interventional
- Phase
- Phase 2
- Interventions
- edoxaban tosylate (Drug); enoxaparin/unfractionated heparin (Drug); warfarin (Drug)
- Age
- Adult, Older Adult · 18+ yrs
- Sex
- All
- Sponsor
- Daiichi Sankyo
- Primary completion
- Jan 2014
Outcome Measures
| Outcome | Result | p-value |
|---|---|---|
| PRIMARY Relative Change From Baseline in Thrombus Volume Assessed by MRI [Using the Magnetic Resonance Venography (MRV) Method] |
-46.6; -51.4 | — |
| SECONDARY Number of Participants With Clinically Relevant Bleeding |
3; 2 | — |
| SECONDARY Number of Participants With Recurrence of Venous Thromboembolism (VTE) |
4; 2 | — |
| SECONDARY Number of Participants With Major Adverse Cardiovascular Events (MACE) |
2; 0 | — |
| SECONDARY Number of Participants With Change From Baseline in the Presence or Absence of Thrombus by Vessel |
0; 0 | — |
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.
Eligibility Criteria
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 = 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 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 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
Data sourced from ClinicalTrials.gov (NCT01662908). Outcome figures and adverse-event rates are extracted automatically from the registry's posted results and are provided for clinician reference, not as a substitute for the primary publication.