Comparing the Safety and Efficacy of Apixaban and Rivaroxaban

Trial statusRecruiting
Trial phasePhase 4
Trial typeInterventional
Biological sexAll
Age65+
SponsorVA Office of Research and Development

About this trial

* The trial will compare two anticoagulants ("blood thinners") that are currently used in the VA and are considered standard care to prevent strokes in patients with atrial fibrillation. The two most commonly-used anticoagulants will be compared: apixaban (Eliquis) and rivaroxaban (Xarelto). They are considered by many doctors to have similar benefits and risks, but no one knows for sure. * The trial only enrolls patients with a diagnosis of atrial fibrillation ("A Fib") or atrial flutter. Most participants will be age 65 or older, and should already be taking apixaban or rivaroxaban. * The investigators will measure, in about 10,000 VA patients nationally, whether the rates of stroke, major bleeding, or death differ between these two drugs. * The trial will last about 7 years, but after the first prescription, all information will be collected from electronic medical records.

Eligibility criteria

Qualifiers

Male or female Veteran, aged 22 years or older

Diagnosis of atrial fibrillation (AF) or atrial flutter (AFL) and currently taking either apixaban or rivaroxaban.

CHA2DS2-Vasc of 3 or more

Ability to take oral medication and self-reported willingness to adhere to the prespecified apixaban or rivaroxaban regimen

Disqualifiers

Current use of oral or injectable anticoagulation, without ability to switch to the assigned study medication

Another indication for anticoagulation, such as pulmonary embolism

Contraindication to oral anticoagulation

Known bleeding diathesis

Trial design

Treatments tested in this trial

  • Apixaban
  • Rivaroxaban

Treatment groups

10,000 Participants
are divided into 2 treatment groups

Sponsors and collaborators

VA Office of Research and Development

Lead sponsor

Food and Drug Administration (FDA)

Collaborator