A Phase III Study of Apixaban in Patients With Atrial Fibrillation

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