RecruitingPhase 4NCT06953726

Comparing the Safety and Efficacy of Apixaban and Rivaroxaban

CSP #2037T - Veterans Affairs Learning Health System Initiative to Assess Novel Screening vs. Usual Care and Treatment With Apixaban vs. Rivaroxaban in Veterans With Atrial Fibrillation (VALIANT-AF-T) Trial

Sponsor

VA Office of Research and Development

Enrollment

10,000 participants

Start Date

Jun 1, 2026

Study Type

INTERVENTIONAL

Conditions

Atrial Fibrillation

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.

Eligibility

Min Age: 65 Years

Inclusion Criteria5

In order to be eligible to participate in this study, an individual must meet all of the following criteria:
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

Exclusion Criteria13

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:
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
Documented current pregnancy or lactation in the EHR or self-reported current pregnancy or lactation
Known allergic reactions or intolerance to apixaban or rivaroxaban
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.
Known mechanical heart valve
Known moderate-severe mitral stenosis
Known history of left atrial occlusion, excision, or ligation
Current or planned use of systemic ritonavir, itraconazole, or ketoconazole (topical use of ketoconazole only is allowed)
Cardiac or thoracic surgery in the past 3 months

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Interventions

DRUGApixaban

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.

DRUGRivaroxaban

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.