Trial of Apixaban vs Warfarin in Reducing Rate of Cognitive Decline, Silent Cerebral Infarcts and Cerebral Microbleeds in Patients With Atrial Fibrillation
Condition: Atrial Fibrillation
MeSH terms: Cerebral Infarction; Atrial Fibrillation
Intervention: Apixaban; Warfarin
Intervention description: Dosage either 5mg or 2.5mg for 2 years; Dosage assessed by your treating physician for 2 years
Intervention MeSH terms: Warfarin; Apixaban
Phase: Phase 3
Study type: Interventional
Primary purpose: Other
Allocation: Randomized
Intervention model: Parallel Assignment
Masking: Single (Outcomes Assessor)
Enrollment: 34.0
Sex: All
Minimum age: 60 Years
Healthy volunteers: No
Keywords: Apixaban; Warfarin

Summary:

      The investigators' central hypothesis is that in patients with atrial fibrillation,
      anticoagulation with Apixaban reduces the rate of decline in cognitive function, when
      compared to Warfarin. The investigators also hypothesize that Apixaban reduces cognitive
      decline by reducing the rate of new cerebral infarction and cerebral microbleeds detected by
      cerebral MRI compared to warfarin.
    

Eligibility criteria:

        Inclusion Criteria:

          -  Non-valvular Atrial Fibrillation

          -  CHA2DS2-VASc Score > or = to 2

          -  Never been treated with Apixaban (Eliquis) or prior treatment of < 1 month

          -  Candidate for oral anticoagulation as assessed by a treating physician

        Exclusion Criteria:

          -  Valvular Atrial Fibrillation (Rheumatic valve disease,Moderate or greater mitral
             stenosis,Mechanical cardiac valve)

          -  Active Bleeding

          -  Prior treatment with Apixaban >1 month

          -  Recent stroke within 7 days

          -  Dementia

          -  Implanted devices not compatible with MRI/any cardiac implanted device

          -  Claustrophobia

          -  Active alcohol/drug abuse

          -  Life expectancy < 1 year

          -  Taking asprin with >100mg doses

          -  Known hypersensitivity to warfarin or Apixaban

          -  Severe renal insufficiency

          -  Prior severe bleeding (Intracranial bleeding (subdural, subarachnoid, intraparenchymal
             bleeding),GI bleed requiring transfusion,Bleeding from other sites requiring
             transfusion)

          -  Psychosocial reasons that make study participation impractical

          -  Currently enrolled in another IND or IDE trial that has not completed the primary
             endpoint or that clinically interferes with the current study endpoints

          -  Co-morbid condition(s) that could limit the subject's ability to participate in the
             trial or to comply with follow-up requirements, or that could impact the scientific
             integrity of the study.

          -  Prisoners or subjects who are involuntarily incarcerated

          -  Subjects who are compulsorily detained for treatment of either psychiatric or physical
             illness

          -  Current or expected systemic treatment with strong dual inhibitors of CYP3A4 and P-gp
             (Any one of rifampin, carbamazepine, phenytoin, St. John's Wort, ketoconazole,
             itraconazole, ritonavir, clarithromycin)

          -  Need for dual anti-platelet therapy with aspirin and another agent such as
             thienopyridine