A Phase III Study of Apixaban in Patients With Atrial Fibrillation

An optional Long-term Open-label Extension Phase of treatment with apixaban will be provided
for qualifying participants following the conclusion of the double-blind phase

Key Inclusion Criteria:

- Male and female

- Age of 50 years or older

- Permanent, paroxysmal, or persistent atrial fibrillation (at screening or within 6
months prior to enrollment) documented by 12-lead electrocardiogram)

- At least 1 of the following risk factors for stroke:

- Prior stroke or transient ischemic attack

- Age of 75 years or older

- Arterial hypertension on treatment

- Diabetes mellitus

- Heart failure (New York Health Authority Class 2 or greater at time of
enrollment)

- Left ventricular ejection fraction of 35% or less, documented within 6 months of
enrollment

- Peripheral arterial disease (previous arterial revascularization, limb or foot
amputation, or current intermittent claudication with ankle-arm systolic blood
pressure ratio <0.9)

- Not currently receiving vitamin K antagonist therapy for 1 of the following reasons:

- Previous vitamin K antagonist therapy demonstrated as unsuitable and discontinued

- Vitamin K antagonist therapy not previously used but expected unsuitable

Key Exclusion Criteria:

- Women who are pregnant or breast feeding

- Women of child bearing potential who are unwilling to meet the study requirements for
pregnancy testing or are unwilling or unable to use an acceptable method to avoid
pregnancy

- Atrial fibrillation due to reversible causes, such as thyrotoxicosis or pericarditis

- Valvular disease requiring surgery

- Planned ablation procedure for atrial fibrillation to be performed within 3 months

- Conditions other than atrial fibrillation that require chronic anticoagulation (such
as, prosthetic mechanical heart valve, venous thromboembolism)

- Patients with serious bleeding in the last 6 months or at high risk for bleeding,
including but not limited to those with:

- Active peptic ulcer disease

- Platelet count <100,000/mm^3 or hemoglobin <10g/dL

- Recent stroke (within 10 days)

- Documented hemorrhagic tendencies or blood dyscrasias

- Current alcohol or drug abuse or psychosocial reasons that make study participation
impractical

- Severe comorbid condition with life expectancy <1 year

- Severe renal insufficiency; any patient with a serum creatinine level >2.5 mg/dL or a
calculated creatinine clearance <25 mL/min is excluded

- Alanine transaminase or aspartate aminotransferase levels >2 times upper limit of
normal (ULN) or a total bilirubin level >1.5 times ULN (unless an alternative
causative factor [such as Gilbert's syndrome] is identified)

- Allergy or adverse reaction to acetylsalicylic acid

- Required treatment with a thienopyridine (clopidogrel or ticlopidine)

- Prisoners or participants who are compulsory detained (involuntarily incarcerated)

- Use of an investigational drug or device within the past 30 days or prior
randomization into an apixaban clinical study

- Patients who are compulsorily detained for treatment for a psychiatric or physical
illness