Trial Information

Summary: A Phase 3, Active (Warfarin) Controlled, Randomized, Double-Blind, Parallel-Arm Study to Evaluate Efficacy and Safety of Apixaban In Preventing Stroke and Systemic Embolism in Patients with Nonvalvular Atrial Fibrillation

40 month study with frequent visits within the first month but then monthly visits for the duration. Fingerstick INRs at all visits where doctors will be asked to adjust patients Warfarin or Warfarin placebo during their visits.

Patient Inclusion Criteria:

• 18 years or older
• Permanent or persistent atrial fibrillation or flutter ~ documented by EKG, rhythm strip or holter (2 tracings)

Patient Exclusion Criteria:

• Atrial fibrillation or flutter due to reversible causes (thyrotoxicosis, pericarditis)
• Clinically significant (Moderate/Severe) mitral stenosis
• Increased bleeding risk that is believed to be a contraindication to oral anticoagulation (e.g. - documented peptic ulcer disease within 6 months)
• Previous intracranial bleed
• Conditions other than atrial fibrillation which require anticoagulation (prosthetic mechanical heart valve)
• Uncontrolled HTN
• Active infective endocarditis
• Planned major surgery
• Planned atrial fibrillation or flutter ablation
• Required treatment of aspirin > 165 mg/day
• Simultaneous Treatment with Aspirin and Clopidogrel or Ticlopidine
• Recent stroke within 30 days

If you would like to learn more about participating in this study, please send an e-mail message using the form below.