A Phase III Study of Apixaban in Patients With Atrial Fibrillation "AVERROES"

Completed

Phase 3 Results

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