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
VA Office of Research and Development
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.
Description
Study hypothesis and design: The study hypothesizes that apixaban will be superior to rivaroxaban for safety (using the International Society on Thrombosis and Haemostasis \[ISTH\] definition of major bleeding) and at least non inferior for efficacy among patients with atrial fibrillation (AF) or atrial flutter (AFL), henceforth collectively "AF." This is a phase 4, pragmatic, point of care, parallel group, unblinded randomized trial embedded in VA clinical care. Enrollment and allocation: Approximately 10,000 Veterans ages 65 years or older with AF and CHA2DS2-Vasc of 3 or more will be ran…
Eligibility
- Age range
- 65+ years
- Sex
- All
- Healthy volunteers
- No
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, aged 22 years or older 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 ant…
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.
Location
- VA Boston Healthcare System Jamaica Plain Campus, Jamaica Plain, MABoston, Massachusetts