Recruiting

Apixaban vs. Rivaroxaban

Sponsor:

VA Office of Research and Development

Code:

NCT06953726

Conditions

Atrial Fibrillation

Eligibility Criteria

Sex: All

Age: 65+

Healthy Volunteers: Not accepted

Interventions

Apixaban

Rivaroxaban

Study Details

Brief 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

Atrial Fibrillation

Study ID

NCT06953726

Start date

Jun 1, 2026

Status verified date

Jun, 2026

Completion date

Oct 3, 2033

Anticipated

Primary completion date

Oct 4, 2032

Anticipated

Eligibility Criteria

Eligibility Criteria

Sex: All

Age: 65+

Healthy Volunteers: Not accepted

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 antiplatelet agents or prior OAC use will not be an exclusion criterion:

1. Current use of oral or injectable anticoagulation, without ability to switch to the assigned study medication
2. Another indication for anticoagulation, such as pulmonary embolism
3. Contraindication to oral anticoagulation
4. Known bleeding diathesis
5. Documented current pregnancy or lactation in the EHR or self-reported current pregnancy or lactation
6. Known allergic reactions or intolerance to apixaban or rivaroxaban
7. 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.
8. Known mechanical heart valve
9. Known moderate-severe mitral stenosis
10. Known history of left atrial occlusion, excision, or ligation
11. Current or planned use of systemic ritonavir, itraconazole, or ketoconazole (topical use of ketoconazole only is allowed)
12. Cardiac or thoracic surgery in the past 3 months

Study Design

Enrollment

10000 participants

Anticipated

Allocation

Randomized

Intervention Model

Parallel Assignment

Primary purpose

Treatment

Interventions and Outcome Measures

Arms

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.

Interventions

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.

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.

Primary outcome measure

  • Onset of ISTH Major Bleeding Event [ Time Frame: 3 years ]
  • Time to First Stroke [ Time Frame: 3 years ]
  • Time to First Systemic Embolism [ Time Frame: 3 years ]
  • Time to All-Cause Mortality [ Time Frame: 3 years ]

Central Contacts and Locations

Central contacts

Locations

Miami VA Healthcare System, Miami, FL

Recruiting

Miami, Florida, United States, 33125

Contacts

Melyssa Sueiro

Melyssa.Sueiro@va.gov

Boston VA CSP Coordinating Center

Recruiting

Boston, Massachusetts, United States, 02111

Contacts

Mustabeen Ashfaq

mustabeen.ashfaq@va.gov

Jacqueline Dibella

Jacqueline.Dibella@va.gov

Minneapolis VA Call Center

Recruiting

Minneapolis, Minnesota, United States, 55417

Contacts

Srihari I Raju

Srihari.Raju@va.gov

Olivia J Taylor

Olivia.Taylor@va.gov

VA Portland Health Care System, Portland, OR

Recruiting

Portland, Oregon, United States, 97207-2964

Contacts

Quinn Clarkson

Quinn.Clarkson@va.gov

Kevin A Osborn

Kevin.Osborn3@va.gov

More Information

Sponsor

VA Office of Research and Development

Last update posted

Jun 22, 2026

Last verified

Jun, 2026

Keywords

  • Atrial Fibrillation
  • Ischemic Stroke
  • Bleeding
  • Major bleeding

Trial information was received from ClinicalTrials.gov and was last updated on 2026-09-09. This information was provided to ClinicalTrials.gov by VA Office of Research and Development on 2026-06-22.