Which anticoagulant is safer and more effective for AF patients: apixaban vs rivaroxaban?

Is this trial a fit for you?

A plain-English reading of the study's rules. Only the study team can confirm whether you qualify.

What this trial studies

This pragmatic, phase 4 trial compares two standard anticoagulants—apixaban and rivaroxaban—within VA clinical care. It enrolls about 10,000 veterans aged 65+ with atrial fibrillation or flutter who are already on one of these medications, collecting data from electronic health records over roughly seven years. The main goals are to see if apixaban reduces major bleeding and whether it is at least as effective as rivaroxaban for preventing ischemic stroke, systemic embolism, or death. Secondary aims include looking at heart failure and acute coronary events, and analyzing each component of the efficacy endpoint separately. The study is unblinded and uses a centralized randomization system across multiple VA sites, with FDA collaboration and VA leadership driving the investigation.

Why it matters

Who can join: the full rules

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
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

Where it's running

• Miami VA Healthcare System, Miami, FL
  Miami, Florida, United States Recruiting
• Boston VA CSP Coordinating Center
  Boston, Massachusetts, United States Recruiting
• Minneapolis VA Call Center
  Minneapolis, Minnesota, United States Recruiting
• VA Portland Health Care System, Portland, OR
  Portland, Oregon, United States Recruiting
• VA Salt Lake City Health Care System, Salt Lake City, UT
  Salt Lake City, Utah, United States Recruiting
• VA Greater Los Angeles Healthcare System, West Los Angeles, CA
  West Los Angeles, California, United States Active not recruiting

Study contacts

• Study coordinator: Mustabeen Ashfaq, MS
• Email: mustabeen.ashfaq@va.gov
• Phone: (857) 364-6026

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How to take part

1. Review the eligibility criteria above with your treating physician.
2. Check the official listing on ClinicalTrials.gov for the latest contact details and recruitment status.
3. Contact the study coordinator or principal investigator to ask for pre-screening. Pre-screening is free and never obligates you to enroll.