NCT03839355

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.

Trial Health

57
Monitor

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Enrollment
34

participants targeted

Target at below P25 for phase_3 atrial-fibrillation

Timeline
Completed

Started Dec 2018

Shorter than P25 for phase_3 atrial-fibrillation

Geographic Reach
1 country

1 active site

Status
terminated

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

Study Start

First participant enrolled

December 19, 2018

Completed
2 months until next milestone

First Submitted

Initial submission to the registry

February 11, 2019

Completed
4 days until next milestone

First Posted

Study publicly available on registry

February 15, 2019

Completed
1.8 years until next milestone

Primary Completion

Last participant's last visit for primary outcome

December 15, 2020

Completed
Same day until next milestone

Study Completion

Last participant's last visit for all outcomes

December 15, 2020

Completed
3 months until next milestone

Results Posted

Study results publicly available

March 16, 2021

Completed
Last Updated

March 16, 2021

Status Verified

February 1, 2021

Enrollment Period

2 years

First QC Date

February 11, 2019

Results QC Date

February 5, 2021

Last Update Submit

February 23, 2021

Conditions

Atrial Fibrillation

Keywords

ApixabanWarfarin

Outcome Measures

Primary Outcomes (3)

  • Standardized Neurocognitive Function Score

    Assess the change in cognitive function using standardized neurocognitive assessment.

    Baseline, Year 1, Year 2

  • MRI Evidence of Silent Cerebral Infarct

    Magnetic Resonance Imagining of the brain to assess the development of new silent cerebral infarcts.

    Baseline, Year 2

  • MRI Evidence of New Cerebral Micro-bleeds

    Magnetic Resonance Imagining of the brain to assess the development of new cerebral micro-bleeds

    Baseline, Year 2

Study Arms (2)

Eliquis

ACTIVE COMPARATOR
Drug: Apixaban

Warfarin

ACTIVE COMPARATOR
Drug: Warfarin

Interventions

ApixabanDRUG

Dosage either 5mg or 2.5mg for 2 years

Also known as: Eliquis
Eliquis
WarfarinDRUG

Dosage assessed by your treating physician for 2 years

Also known as: Coumadin
Warfarin

Eligibility Criteria

Age60 Years+
Sexall
Healthy VolunteersNo
Age GroupsAdult (18-64), Older Adult (65+)

You may qualify if:

  • 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

You may not qualify if:

  • 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
  • +5 more criteria

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

Mayo Clinic in Rochester

Rochester, Minnesota, 55905, United States

Location

Related Links

MeSH Terms

Conditions

Atrial Fibrillation

Interventions

apixabanWarfarin

Condition Hierarchy (Ancestors)

Arrhythmias, CardiacHeart DiseasesCardiovascular DiseasesPathologic ProcessesPathological Conditions, Signs and Symptoms

Intervention Hierarchy (Ancestors)

4-HydroxycoumarinsCoumarinsBenzopyransPyransHeterocyclic Compounds, 1-RingHeterocyclic CompoundsHeterocyclic Compounds, 2-RingHeterocyclic Compounds, Fused-Ring

Results Point of Contact

Title
Dr. Malini Madhavan
Organization
Mayo Clinic
Madhavan.Malini@mayo.edu
507-255-4152

Study Officials

  • Malini Madhavan

    Mayo Clinic

    PRINCIPAL INVESTIGATOR

Publication Agreements

PI is Sponsor Employee
Yes

Study Design

Study Type
interventional
Phase
phase 3
Allocation
RANDOMIZED
Masking
SINGLE
Who Masked
OUTCOMES ASSESSOR
Purpose
OTHER
Intervention Model
PARALLEL
Sponsor Type
OTHER
Responsible Party
PRINCIPAL INVESTIGATOR
PI Title
Principal Investigator

Study Record Dates

First Submitted

February 11, 2019

First Posted

February 15, 2019

Study Start

December 19, 2018

Primary Completion

December 15, 2020

Study Completion

December 15, 2020

Last Updated

March 16, 2021

Results First Posted

March 16, 2021

Record last verified: 2021-02

Locations

US(1)