NCT06953726 · VA Office of Research and Development
Comparing the Safety and Efficacy of Apixaban and Rivaroxaban
(VALIANT-AF-T)
What this study is about
* 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.
View original scientific 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.
Who can participate
This study lists these criteria on ClinicalTrials.gov. A study coordinator reviews eligibility during screening — this page does not determine whether you qualify.
Inclusion criteria
- 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 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:
- 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
Where
- Miami, Florida
- Boston, Massachusetts
- Minneapolis, Minnesota
- Portland, Oregon
Frequently asked questions
What is a clinical trial?
A clinical trial is a research study that tests new medical treatments, drugs, devices, or procedures to determine their safety and effectiveness. Trials are carefully designed and monitored to protect participants while advancing medical knowledge.
Is it safe to participate?
Clinical trials follow strict safety guidelines and ethical standards. Trials must be reviewed and approved, and participants are closely monitored by medical professionals throughout the study. You can withdraw at any time if you choose.
Will I be compensated?
Many clinical trials offer compensation for your time, travel expenses, and inconvenience. The specific compensation varies by study and will be discussed during the screening process. All study-related medical care is typically provided at no cost to participants.
Will I receive a placebo instead of treatment?
When effective treatment exists, participants typically receive either the standard treatment plus the study intervention, or the standard treatment plus placebo. You would not be denied effective care. Placebos are primarily used when no proven treatment is available, or in addition to standard care. Your trial consent form will clearly explain what treatments you may receive.
Can I leave a trial if I change my mind?
Absolutely. Participation in clinical trials is completely voluntary. You have the right to withdraw from the study at any time, for any reason, without penalty or loss of benefits to which you are otherwise entitled.
How long does a clinical trial last?
Trial duration varies widely depending on the study design and purpose. Some trials last just a few weeks, while others may continue for months or years. The study coordinator will provide specific timeline information during your screening call.
Data: ClinicalTrials.gov · synced Jun 22, 2026 · Source of record for eligibility and locations