Clinical trial NCT00496769 (phase 3, status: completed)
Conditions: atrial fibrillation
ICD codes: I48.0, I48.21, I48.91, I48.11, I48.19, I48.20
Drugs: apixaban, acetylsalicylic acid
SMILES: COC1=CC=C(C=C1)N1N=C(C(N)=O)C2=C1C(=O)N(CC2)C1=CC=C(C=C1)N1CCCCC1=O, CC(=O)OC1=CC=CC=C1C(O)=O
Eligibility criteria:

        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