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Comparing the Safety and Efficacy of Apixaban and Rivaroxaban

NCT06953726 · Status: NOT_YET_RECRUITING · Phase: PHASE4 · Type: INTERVENTIONAL · Enrollment: 10000

Last updated 2026-04-09

No results posted yet for this study

Summary

* 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.

Conditions

Interventions

DRUG

Apixaban

Study participants will be randomized to twice daily oral administration of apixaban 5mg. 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.

DRUG

Rivaroxaban

Study participants will be randomized to daily oral administration of rivaroxaban 20mg. Reduced dose rivaroxaban (15 mg once daily) will be given to participants with a creatinine clearance 15-50 mL/min.

Sponsors & Collaborators

  • U.S. Food and Drug Administration (FDA)

    collaborator UNKNOWN

  • VA Office of Research and Development

    lead FED

Principal Investigators

  • William E. Boden, MD · VA Boston Healthcare System Jamaica Plain Campus, Jamaica Plain, MA

  • Cara N Pellegrini · San Francisco VA Medical Center, San Francisco, CA

Study Design

Allocation
RANDOMIZED
Purpose
TREATMENT
Masking
NONE
Model
PARALLEL

Eligibility

Min Age
65 Years
Sex
ALL
Healthy Volunteers
No

Timeline & Regulatory

Start
2026-06-01
Primary Completion
2032-10-04
Completion
2033-10-03
FDA Drug
Yes

Countries

  • United States

Study Locations

More Related Trials

Entities

Diseases

Read the full study record

This page highlights key information. For complete eligibility criteria, study locations, investigator contacts, and the full protocol, visit the original record on ClinicalTrials.gov.

View NCT06953726 on ClinicalTrials.gov