Trial of Apixaban vs Warfarin in Reducing Rate of Cognitive Decline, Silent Cerebral Infarcts and Cerebral Microbleeds in Patients With Atrial Fibrillation

Overview

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.

Full Title of Study: “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”

Study Type

  • Study Type: Interventional
  • Study Design
    • Allocation: Randomized
    • Intervention Model: Parallel Assignment
    • Primary Purpose: Other
    • Masking: Single (Outcomes Assessor)
  • Study Primary Completion Date: December 15, 2020

Interventions

  • Drug: Apixaban
    • Dosage either 5mg or 2.5mg for 2 years
  • Drug: Warfarin
    • Dosage assessed by your treating physician for 2 years

Arms, Groups and Cohorts

  • Active Comparator: Eliquis
  • Active Comparator: Warfarin

Clinical Trial Outcome Measures

Primary Measures

  • 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.
  • 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

Participating in This Clinical Trial

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

Gender Eligibility: All

Minimum Age: 60 Years

Maximum Age: N/A

Are Healthy Volunteers Accepted: No

Investigator Details

  • Lead Sponsor
    • Mayo Clinic
  • Collaborator
    • Pfizer
  • Provider of Information About this Clinical Study
    • Principal Investigator: Malini Madhavan, Principal Investigator – Mayo Clinic
  • Overall Official(s)
    • Malini Madhavan, Principal Investigator, Mayo Clinic

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