Comparing the Safety and Efficacy of Apixaban and Rivaroxaban

PHASE4Not yet recruitingINTERVENTIONAL
Enrollment

10,000

Participants

Timeline

Start Date

June 2, 2025

Primary Completion Date

October 4, 2032

Study Completion Date

October 3, 2033

Conditions
Atrial Fibrillation
Interventions
DRUG

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.

DRUG

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.

Trial Locations (1)

02130-4817

VA Boston Healthcare System Jamaica Plain Campus, Jamaica Plain, MA, Boston

All Listed Sponsors
collaborator

U.S. Food and Drug Administration (FDA)

UNKNOWN

lead

VA Office of Research and Development

FED