Clinical trial NCT03196349: Comparison of Oral Anticoagulants for Extended VEnous Thromboembolism
Official title: Comparison of Oral Anticoagulants for Extended VEnous Thromboembolism (COVET)
Study type: INTERVENTIONAL
Overall status: TERMINATED
Phase: PHASE4
Conditions: Venous Thromboembolism
Lead sponsor: Duke University
Sponsor class: OTHER
Collaborators: name: Patient-Centered Outcomes Research Institute
First posted: 2017-06-22
Enrollment: 44
Sex: ALL
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: TREATMENT

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

Detailed description: Determine if apixaban is superior to warfarin in the reduction of clinically relevant bleeding. Determine if rivaroxaban is superior to warfarin in the reduction of clinically relevant bleeding. Determine if apixaban is non-inferior to warfarin in the prevention of recurrent venous thromboembolism. Determine if rivaroxaban is non-inferior to warfarin in the prevention of recurrent venous thromboembolism. An exploratory comparison of apixaban versus rivaroxaban for the prevention of clinically relevant bleeding and recurrent Venous Thromboembolism (VTEs) as a secondary objective.

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

Primary outcomes:
measure: Number of Subjects With Clinically Relevant Bleeding Events
timeFrame: Randomization to 12 months
measure: Number of Subjects With Recurrent Venous Thromboembolism (VTE)
timeFrame: Randomization to 12 months
Secondary outcomes:
Other outcomes:
measure: Number of Subjects Experiencing Major Bleeding
timeFrame: Randomization to 12 months
measure: Number of Subjects Experiencing Clinically Relevant Non-major Bleeding
timeFrame: Randomization to 12 months
measure: Number of Subjects With Premature Termination of Study Medication
timeFrame: Randomization to 12 months
measure: Number of Subjects Experiencing All-cause Mortality
timeFrame: Randomization to 12 months
measure: Number of Subjects Experiencing Vascular Events (Myocardial Infarction, Ischemic Stroke)
timeFrame: Randomization to 12 months
Locations:
city: Orange
country: United States
facility: University of California Irvine Medical Center
state: California
Study officials:
affiliation: Duke University
name: Thomas Ortel, MD
role: PRINCIPAL_INVESTIGATOR
References: