Status:
NOT_YET_RECRUITING
Comparing the Safety and Efficacy of Apixaban and Rivaroxaban
Lead Sponsor:
VA Office of Research and Development
Collaborating Sponsors:
U.S. Food and Drug Administration (FDA)
Conditions:
Atrial Fibrillation
Eligibility:
All Genders
65+ years
Phase:
PHASE4
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 ...
Detailed Description
The study hypothesis is that apixaban will be superior to rivaroxaban with respect to safety using the International Society of Thrombosis and Haemostasis (ISTH) definition of major bleeding and at le...
Eligibility Criteria
Inclusion
- 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 AF or AFL
- CHADS2VASc \>=3
- Ability to take oral medication and self-reported willingness to adhere to the prespecified apixaban or rivaroxaban regimen
Exclusion
- 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:
- Current use of oral or injectable anticoagulation, without ability to switch to the assigned study medication
- Another indication for anticoagulation, such as pulmonary embolism
- Contraindication to oral anticoagulation
- Known bleeding diathesis
- Pregnancy or lactation
- Known allergic reactions or intolerance to apixaban or rivaroxaban
- Estimated glomerular filtration rate (eGFR) of \< 30 mL/minute
- Mechanical heart valve
- Moderate-severe mitral stenosis
- History of left atrial occlusion, excision, or ligation
- Current or planned use of ritonavir, itraconazole, or ketoconazole
- Cardiac or thoracic surgery in the past 3 months
Key Trial Info
Start Date :
June 2 2025
Trial Type :
INTERVENTIONAL
Allocation :
ESTIMATED
End Date :
October 3 2033
Estimated Enrollment :
10000 Patients enrolled
Trial Details
Trial ID
NCT06953726
Start Date
June 2 2025
End Date
October 3 2033
Last Update
May 1 2025
Active Locations (1)
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1
VA Boston Healthcare System Jamaica Plain Campus, Jamaica Plain, MA
Boston, Massachusetts, United States, 02130-4817