Phase 3
N=8,292
Comparative Investigation of Low Molecular Weight (LMW) Heparin/Edoxaban Tosylate (DU176b) Versus (LMW) Heparin/Warfarin in the Treatment of Symptomatic Deep-Vein Blood Clots and/or Lung Blood Clots. (The Edoxaban Hokusai-VTE Study).
Venous Thromboembolism · Deep Vein Thrombosis (DVT) · Pulmonary Embolism (PE) · Thromboembolism · Venous Thrombosis
Bottom Line
View on ClinicalTrials.gov: NCT00986154 ↗Enrolled (actual)
8,292
Serious AEs
20.1%
Results posted
Feb 2015
Primary outcome: Primary: Symptomatic Recurrent VTE, i.e., the Composite of DVT, Non-fatal PE, and Fatal PE — 130; 146 number or participants with an event — p=<0.0001
Study Design & Population
- Study type
- Interventional
- Phase
- Phase 3
- Interventions
- edoxaban tosylate(DU-176b) (Drug); low molecular weight heparin/unfractionated heparin (Drug); warfarin (Drug)
- Age
- Adult, Older Adult · 18+ yrs
- Sex
- All
- Sponsor
- Daiichi Sankyo
- Primary completion
- Apr 2013
Outcome Measures
| Outcome | Result | p-value |
|---|---|---|
| PRIMARY Symptomatic Recurrent VTE, i.e., the Composite of DVT, Non-fatal PE, and Fatal PE |
130; 146 | <0.0001 sig |
| SECONDARY The Composite Clinical Outcome of Symptomatic Recurrent VTE and All-cause Mortality |
228; 228 | .9933 |
| SECONDARY Clinically Relevant Bleeding (i.e., Major or Clinically Relevant Non-major Bleeding) Occurring During Treatment |
349; 423 | .0040 sig |
Summary
Evaluation of heparin/edoxaban tosylate (DU176b) versus heparin/warfarin in preventing recurrence of blood clots in patients with acute symptomatic deep-vein blood clots in the legs and/or blood clots in the lungs.
Eligibility Criteria
Inclusion Criteria
- Male or female subjects older than the minimum legal adult age (country specific);
- Acute symptomatic proximal DVT and/or symptomatic PE confirmed at the site by appropriate diagnostic imaging;
- Able to provide written informed consent
Exclusion Criteria
- thrombectomy, insertion of a caval filter, or use of a fibrinolytic agent to treat the current episode of DVT and/or PE;
- More than 48 hours pre-treatment with anticoagulant therapy prior to randomization;
- Calculated Creatinine clearance (CrCL) \= 2 times the upper limit of normal (ULN), or total bilirubin (TBL) x 1.5 times the ULN;
- patients with active cancer for whom long term treatment with (LMW) heparin is anticipated;
- active bleeding or high risk for bleeding contraindicating treatment with (LMW) heparin or warfarin;
- chronic treatment with non-aspirin non-steroidal anti-inflammatory drugs (NSAIDs);
- treatment with aspirin in a dosage of more than 100 mg/per day or dual antiplatelet therapy;
- concurrent treatment with potent P-gp inhibitors;
- subjects with any condition that, as judged by the investigator, would place the subject at increased risk of harm if he/she participated in the study
Data sourced from ClinicalTrials.gov (NCT00986154). 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.