Comparison of Oral Anticoagulants for Extended VEnous Thromboembolism

• Status: Terminated
• Trial end date: 2019-05-01
• Target enrollment: 0
• Participant gender: All

Summary

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

• Phase: Phase 4
• Accepts Healthy Volunteers?: No

Details

• Lead Sponsor: Duke University
• Collaborator: Patient-Centered Outcomes Research Institute
• Treatments: Anticoagulants; Apixaban; Rivaroxaban; Warfarin

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