Trial to Evaluate Anticoagulation Therapy in Hemodialysis Patients With Atrial Fibrillation

This is a multicenter study in adult patients with AF and ESRD who are on hemodialysis and
who have stroke risk factors making them candidates for oral anticoagulation. Patients will
be randomized to apixaban versus warfarin, and will be treated for up to 15 months.

Inclusion Criteria:

- Males and females, age at least 18 years, or the local age of consent, whichever is
greater.

- Patients with AF defined as AF on ECG at enrollment or two or more reports of AF from
separate monitoring events at least 2 weeks apart (report of ECG, Holter monitor,
event monitor or implantable loop recorder).

- CHA2DS2-VASc score of ≥ 2.

- End-stage renal disease treated with hemodialysis for ≥ 3 months.

- Considered by the treating physician(s) to be candidate for oral anticoagulation.

- If of childbearing potential, be willing to avoid pregnancy during the study.

Exclusion Criteria:

- Not considered by the treating physician(s) to be candidates for oral anticoagulation
(for example, hemoglobin < 8.5g/dL, history of intracranial hemorrhage, active
bleeding, recent gastrointestinal bleed or retroperitoneal bleed, severe hepatic
impairment, or anaphylactic reaction to apixaban)

- Moderate or severe mitral stenosis

- Conditions other than AF that require anticoagulation such as mechanical prosthetic
valve, deep venous thrombosis, or pulmonary embolism

- Need for aspirin at a dose > 81 mg a day or need for P2Y12 antagonist therapy (for
example clopidogrel, prasugrel, or ticagrelor)

- Life expectancy < 3 months

- Anticipated kidney transplant within the next 3 months

- Prisoners or others who are involuntarily incarcerated or detained

- Pregnant, breastfeeding, or considering pregnancy.

- Participation in a clinical trial of an experimental treatment within the past 30 days