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).
Condition: Venous Thromboembolism; Deep Vein Thrombosis (DVT); Pulmonary Embolism (PE); Thromboembolism; Venous Thrombosis
MeSH terms: Pulmonary Embolism; Thrombosis; Embolism; Thromboembolism; Venous Thromboembolism; Venous Thrombosis
Intervention: edoxaban tosylate(DU-176b); low molecular weight heparin/unfractionated heparin; warfarin
Intervention description: edoxaban tosylate(DU-176b), film-coated tablet for oral use, 30 mg, two tablets (60 mg) once daily, maximum of 12 months treatment; LMW heparin - subcutaneous injection, 1 mg/Kg twice daily or 1.5 mg/Kg once daily.
Unfractionated heparin - 5,000 IU bolus intravenous administration, 1,300 IU/hour continuous infusion, minimum of 5 days and maximum of about 12 days treatment; tablet for oral use; 0.5 mg, 1 mg, 2.5 mg, 5 mg; daily dosage, adjusted to maintain international normalized ratio (INR) between 2.0 and 3.0; maximum of 12 months treatment
Intervention MeSH terms: Heparin; Calcium heparin; Heparin, Low-Molecular-Weight; Tinzaparin; Dalteparin; Warfarin; Edoxaban
Phase: Phase 3
Study type: Interventional
Primary purpose: Treatment
Allocation: Randomized
Intervention model: Parallel Assignment
Masking: Triple (Participant, Investigator, Outcomes Assessor)
Enrollment: 8292.0
Sex: All
Minimum age: 18 Years
Healthy volunteers: No
Keywords: Recurrent Thrombosis; Recurrent Pulmonary Embolism; Symptomatic Deep Vein Thrombosis; Symptomatic Pulmonary Embolism; Venous Thromboembolism (VTE)

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) < 30 mL/min;

          -  significant liver disease (e.g., acute hepatitis, chronic active hepatitis, cirrhosis)
             or alanine transaminase (ALT) >\= 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