Comparison of Oral Anticoagulants for Extended VEnous Thromboembolism
Condition: Venous Thromboembolism
MeSH terms: Thromboembolism; Venous Thromboembolism
Intervention: Warfarin; Apixaban 2.5 MG; Rivaroxaban 10 MG
Intervention description: Will be randomized to receive open label warfarin daily to achieve a target INR of 2-3; Will be randomized to receive open label apixaban of 2.5 mg twice daily; Will be randomized to receive open label rivaroxaban of 10mg daily
Intervention MeSH terms: Warfarin; Rivaroxaban; Apixaban
Phase: Phase 4
Study type: Interventional
Primary purpose: Treatment
Allocation: Randomized
Intervention model: Parallel Assignment
Masking: Single (Outcomes Assessor)
Enrollment: 44.0
Sex: All
Minimum age: 18 Years
Healthy volunteers: No

Summary:

      Comparison of Oral anticoagulants (warfarin, apixaban and rivaroxaban) for extended VEnous
      Thromboembolism.
    

Eligibility criteria:

        3.1 Inclusion Criteria

        To be eligible for this trial, patients must meet all of the following criteria:

          -  Have confirmed acute, symptomatic, first lower extremity proximal DVT and/or PE that
             is NOT associated with a transient risk factor.

          -  Have completed an initial treatment course of oral anticoagulant therapy for 3-12
             months and have a recommendation from their provider to continue anticoagulation
             indefinitely.

          -  Have the capacity to understand and sign an informed consent form.

          -  Be 18 years of age and older.

          -  Under the direct care of a healthcare provider for treatment of VTE for the length of
             time in the study.

        3.2 Exclusion Criteria

        If a patient meets any of the following criteria, he or she may not be enrolled in the
        study:

          -  Creatinine clearance (CrCl) < 30 mL/min as determined by Cockcroft-Gault formula
             documented within 3 months from date of consent

          -  Significant liver disease (Child-Pugh B or C)

          -  Concomitant use of medications that are strong P-glycoprotein or CYP3A4
             inducers/inhibitors

          -  Another indication for chronic therapeutic-dose anticoagulation, such as atrial
             fibrillation (i.e., rivaroxaban, 10 mg daily, or apixaban, 2.5 mg twice daily, would
             not be appropriate therapy)

          -  A clinical indication for a specific anticoagulant regimen (e.g., warfarin with a
             target INR of 2-3 is recommended for patients with 'triple-positive' antiphospholipid
             syndrome).

          -  Life expectancy < 3 months

          -  Currently pregnant or breast feeding

          -  Unable / unwilling to pay for one (or more) of the treatment options

          -  Active Cancer defined as:

        Diagnosed with cancer within the past 6 months; or Recurrent, regionally advanced or
        metastatic disease; Currently receiving treatment or have received any treatment for cancer
        during the 6 months prior to randomization; or A hematologic malignancy not in complete
        remission

        • Unwilling / unlikely to agree to follow up