Comparing the Safety and Efficacy of Apixaban and Rivaroxaban

Conditions

• Atrial Fibrillation

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

First listed

May 1, 2025

Start date

Jun 1, 2026

Status verified

Jun 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

• Mustabeen Ashfaq, MS
  (857) 364-6026
  [email protected]
• Paul A Monach, MD PhD
  (857) 364-5552
  [email protected]

Locations (5)

Find similar trials in Miami, FL

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