Health TrialsbyHealthPanel

Comparing the Safety and Efficacy of Apixaban and Rivaroxaban

ConditionAtrial Fibrillation
Trial statusRecruiting
Trial phasePhase 4
Trial typeInterventional
Biological sexAll
Age65+
SponsorVA Office of Research and Development

About this trial

* 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.

Eligibility criteria

This trial does not accept healthy volunteers

Qualifiers

Male or female Veteran, aged 22 years or older

Diagnosis of atrial fibrillation (AF) or atrial flutter (AFL) and currently taking either apixaban or rivaroxaban.

CHA2DS2-Vasc of 3 or more

Ability to take oral medication and self-reported willingness to adhere to the prespecified apixaban or rivaroxaban regimen

Disqualifiers

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

Trial design

Design model

Parallel

Treatments tested in this trial

  • 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.

Treatment groups

10,000 Participants
are divided into 2 treatment groups
Group A: Apixaban ArmActive comparator 1 intervention
Group B: Rivaroxaban ArmActive comparator 1 intervention

Trial outcomes

Primary outcomes

1

Onset of ISTH Major Bleeding Event

Hospitalization for first ISTH-defined major bleeding, as determined by ICD-10 codes associated with hospitalization. This is the primary safety outcome.

Time frame
3 years
2

Time to First Stroke

Hospitalization for first stroke, as determined by ICD-10 codes associated with hospitalization. The primary efficacy outcome is time to first event of stroke or systemic embolism, or death of any cause, in days.

Time frame
3 years
3

Time to First Systemic Embolism

Hospitalization for first systemic embolism, as determined by ICD-10 codes associated with hospitalization. The primary efficacy outcome is time to first event of stroke or systemic embolism, or death of any cause, in days.

Time frame
3 years
4

Time to All-Cause Mortality

Time to all-cause mortality, as determined by VA data on vital status. The primary efficacy outcome is time to first event of stroke or systemic embolism, or death of any cause, in days.

Time frame
3 years

Secondary outcomes

1

Time to First Stroke, Systemic Embolism, or All-Cause Mortality

Time to first stroke, systemic embolism, or all-cause mortality (Superiority Hypothesis), as determined by ICD-10 codes associated with hospitalization, or by VA data on vital status.

Time frame
3 years
2

Time to First Stroke

Time to first stroke, as determined by ICD-10 codes associated with hospitalization. Not part of the Superiority Hypothesis but part of the hierarchically ranked secondary outcome measures.

Time frame
3 years
3

Time to First Hospitalization for Heart Failure, Myocardial Infarction, or Acute Coronary Syndrome

Time to first hospitalization for heart failure, myocardial infarction, or acute coronary syndrome, as determined by ICD-10 codes associated with hospitalization.

Time frame
3 years
4

Time to First systemic embolism

Time to first systemic embolism, as determined by ICD-10 codes associated with hospitalization.

Time frame
3 years

Other outcomes

Sponsors and contacts

Click on the lead sponsor to view all of their trials.

VA Office of Research and Development

Lead sponsor

Food and Drug Administration (FDA)

Collaborator

Source ClinicalTrials.gov
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