Randomized Trial of Apixaban vs Dose Adjusted Warfarin in Reducing Rate of Cognitive Function Decline, Silent Cerebral Infarcts and Cerebral Microbleeds in Non-valvular Atrial Fibrillation Patients With CHA2DS2-VaSc Score = 2
Overview
- Phase
- Phase 3
- Intervention
- Apixaban
- Conditions
- Atrial Fibrillation
- Sponsor
- Mayo Clinic
- Enrollment
- 34
- Locations
- 1
- Primary Endpoint
- MRI Evidence of New Cerebral Micro-bleeds
- Status
- Terminated
- Last Updated
- 5 years ago
Overview
Brief 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.
Investigators
Malini Madhavan
Principal Investigator
Mayo Clinic
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
- •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
Arms & Interventions
Eliquis
Intervention: Apixaban
Warfarin
Intervention: Warfarin
Outcomes
Primary Outcomes
MRI Evidence of New Cerebral Micro-bleeds
Time Frame: Baseline, Year 2
Magnetic Resonance Imagining of the brain to assess the development of new cerebral micro-bleeds
Standardized Neurocognitive Function Score
Time Frame: Baseline, Year 1, Year 2
Assess the change in cognitive function using standardized neurocognitive assessment.
MRI Evidence of Silent Cerebral Infarct
Time Frame: Baseline, Year 2
Magnetic Resonance Imagining of the brain to assess the development of new silent cerebral infarcts.