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RECRUITING Phase 4 ClinicalTrials.gov

Comparing the Safety and Efficacy of Apixaban and Rivaroxaban

Sponsor: VA Office of Research and Development • ClinicalTrials.gov ID: NCT06953726

Registry updated: 2026-09-23
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Description

* 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.

Interventions

  • Apixaban (Drug)
    Study participants will be randomized to twice daily oral administration of apixaban 5 milligrams (mg). Reduced dose apixaban (2.5 mg twice daily) will be given to participants who meet 2 of the 3 criteria: age 80 years, body weight 60 kg, and serum creatinine 1.5 mg/dL.
  • Rivaroxaban (Drug)
    Study participants will be randomized to daily oral administration of rivaroxaban 20 milligrams (mg). Reduced dose rivaroxaban (15 mg once daily) will be given to participants with a creatinine clearance 15-50 mL/min.

Eligibility criteria

Inclusion Criteria: In order to be eligible to participate in this study, an individual must meet all of the following criteria: 1. Male or female Veteran 2. Diagnosis of atrial fibrillation (AF) or atrial flutter (AFL) and currently taking either apixaban or rivaroxaban. 3. CHA2DS2-Vasc of 3 or more 4. Ability to take oral medication and self-reported willingness to adhere to the prespecified apixaban or rivaroxaban regimen Exclusion Criteria: An individual who meets any of the following criteria will be excluded from participation in this study; notably use of antiplatelet agents or prior OAC use will not be an exclusion criterion: 1. Current use of oral or injectable anticoagulation, without ability to switch to the assigned study medication 2. Another indication for anticoagulation, such as pulmonary embolism 3. Contraindication to oral anticoagulation 4. Known bleeding diathesis 5. Documented current pregnancy or lactation in the EHR or self-reported current pregnancy or lactation 6. Known allergic reactions or intolerance to apixaban or rivaroxaban 7. Most recent estimated glomerular filtration rate (eGFR) is \< 30 mL/minute/1.73m2. An eGFR result must have been obtained within 18 months before randomization. 8. Known mechanical heart valve 9. Known moderate-severe mitral stenosis 10. Known history of left atrial occlusion, excision, or ligation 11. Current or planned use of systemic ritonavir, itraconazole, or ketoconazole (topical use of ketoconazole only is allowed) 12. Cardiac or thoracic surgery in the past 3 months

Conditions

Atrial Fibrillation

Locations

  • VA Greater Los Angeles Healthcare System, West Los Angeles, CA — West Los Angeles, California, United States
  • Miami VA Healthcare System, Miami, FL — Miami, Florida, United States
  • Boston VA CSP Coordinating Center — Boston, Massachusetts, United States
  • VA Boston Healthcare System Jamaica Plain Campus, Jamaica Plain, MA — Boston, Massachusetts, United States
  • Minneapolis VA Call Center — Minneapolis, Minnesota, United States
  • Louis Stokes VA Medical Center, Cleveland, OH — Cleveland, Ohio, United States
  • VA Portland Health Care System, Portland, OR — Portland, Oregon, United States
  • Corporal Michael J. Crescenz VA Medical Center, Philadelphia, PA — Philadelphia, Pennsylvania, United States
  • VA Salt Lake City Health Care System, Salt Lake City, UT — Salt Lake City, Utah, United States
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Official Source

Data sourced from ClinicalTrials.gov, a service of the U.S. National Institutes of Health.

View Official Record