Trial Information

Summary: Clinical Research Study for Adult Subjects with Nonvalvular Atrial Fibrillation

Protocol Title:
Protocol CV185030: 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 Subjects with Nonvalvular Atrial Fibrillation

Expected Total Enrollment: 15,000 subjects worldwide

Study Start: December 2006

Key Inclusion Criteria:

• Males and females, age =18 years
• Permanent or persistent atrial fibrillation or flutter OR atrial fibrillation or flutter documented on 2 separate occasions (=2 weeks apart within the last 6 months)
• 1 or more of the following risk factors for stroke:
  • Age =75 years
  • Prior stroke, transient ischemic attack (TIA), or systemic embolus
  • Either symptomatic congestive heart failure within 3 months OR left ventricular dysfunction with an LV ejection fraction (LVEF) =40%
  • Diabetes mellitus
  • Hypertension requiring pharmacological treatment

  Key Exclusion Criteria:

  • Atrial fibrillation or flutter due to reversible causes
  • Clinically significant (moderate or severe) mitral stenosis
  • Increased bleeding risk that is believed to be a contraindication to oral anticoagulation (eg, documented peptic ulcer disease within 6 months, previous intracranial hemorrhage)
  • Conditions other than atrial fibrillation that require chronic anticoagulation
  • Persistent, uncontrolled hypertension (systolic BP >180 mm Hg, or diastolic BP >100 mm Hg)
  • Recent stroke (within 30 days)
  • Inability to comply with INR monitoring

  For more information,

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