Comparing the Safety and Efficacy of Apixaban and Rivaroxaban

Part of paid clinical trials in Boston, Massachusetts.

Sponsor
VA Office of Research and Development
Study ID
NCT06953726
Phase
PHASE4
Status
Not Yet Recruiting

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Conditions

Eligibility Criteria

Sex
ALL
Age
65 Years - N/A
Healthy Volunteers
Not accepted

Interventions

  • Apixaban — DRUG
    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 — DRUG
    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.

Study Details

* 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.

Key Dates

Start date
Jun 1, 2026
Status verified
Apr 2026
Primary completion
Oct 4, 2032
Completion
Oct 3, 2033

Study Design

Enrollment
10,000 participants (estimated)
Allocation
RANDOMIZED
Intervention model
PARALLEL
Primary purpose
TREATMENT

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.

Primary Outcome Measure

Onset of ISTH Major Bleeding Event [ Time Frame: 3 years ]

Central Contacts

Locations (1)

FacilityCityStateZIPSite coordinators
VA Boston Healthcare System Jamaica Plain Campus, Jamaica Plain, MABostonMassachusetts02130-4817
Mustabeen Ashfaq, MS
[email protected]
857-364-6026
William E. Boden, MD (STUDY_CHAIR)

Find similar trials in Boston, MA

By condition
Atrial fibrillation
By specialty
CardiologyHeart disease
By research site
VA Boston Healthcare System Jamaica Plain Campus, Jamaica Plain, MA· Boston, MA

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