Atrial Fibrillation Clinical Trials

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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

Status: Recruiting
Location: See all (5) locations...
Intervention Type: Drug
Study Type: Interventional
Study Phase: Phase 4
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
Participation Requirements
Sex: All
Minimum Age: 65
Healthy Volunteers: f
View:

⁃ 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

Locations
United States
Florida
Miami VA Healthcare System, Miami, FL
RECRUITING
Miami
Massachusetts
Boston VA CSP Coordinating Center
RECRUITING
Boston
VA Boston Healthcare System Jamaica Plain Campus, Jamaica Plain, MA
NOT_YET_RECRUITING
Boston
Minnesota
Minneapolis VA Call Center
RECRUITING
Minneapolis
Oregon
VA Portland Health Care System, Portland, OR
RECRUITING
Portland
Contact Information
Primary
Mustabeen Ashfaq, MS
mustabeen.ashfaq@va.gov
(857) 364-6026
Backup
Paul A Monach, MD PhD
Paul.Monach@va.gov
(857) 364-5552
Time Frame
Start Date: 2026-06-01
Estimated Completion Date: 2033-10-03
Participants
Target number of participants: 10000
Treatments
Active_comparator: Apixaban Arm
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 or older, body weight of 60 kg or lower, serum creatinine of 1.5 mg/dL or higher
Active_comparator: Rivaroxaban Arm
Study participants will be randomized to daily oral administration of rivaroxaban 20mg if creatinine clearance of 50 mL/min or more. Reduced dose rivaroxaban (15 mg once daily) will be given to participants with a creatinine clearance 15-50 mL/min.
Related Therapeutic Areas
Sponsors
Leads: VA Office of Research and Development
Collaborators: Food and Drug Administration (FDA)

This content was sourced from clinicaltrials.gov