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

February 23, 2021 updated by: Malini Madhavan, Mayo Clinic

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

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.

Study Overview

Status

Terminated

Conditions

Intervention / Treatment

Study Type

Interventional

Enrollment (Actual)

34

Phase

  • Phase 3

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Locations

  • United States
    • Minnesota
      • Rochester, Minnesota, United States, 55905
        • Mayo Clinic in Rochester

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

60 years and older (ADULT, OLDER_ADULT)

Accepts Healthy Volunteers

No

Genders Eligible for Study

All

Description

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

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

  • Primary Purpose: OTHER
  • Allocation: RANDOMIZED
  • Interventional Model: PARALLEL
  • Masking: SINGLE

Arms and Interventions

Participant Group / Arm
Intervention / Treatment
ACTIVE_COMPARATOR: Eliquis
Drug: Apixaban
Dosage either 5mg or 2.5mg for 2 years
Other Names:
  • Eliquis
ACTIVE_COMPARATOR: Warfarin
Drug: Warfarin
Dosage assessed by your treating physician for 2 years
Other Names:
  • Coumadin

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Measure Description
Time Frame
Standardized Neurocognitive Function Score
Time Frame: Baseline, Year 1, Year 2
Assess the change in cognitive function using standardized neurocognitive assessment.
Baseline, Year 1, Year 2
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.
Baseline, Year 2
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
Baseline, Year 2

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

Mayo Clinic

Collaborators

Bristol-Myers Squibb
Pfizer

Investigators

  • Principal Investigator: Malini Madhavan, Mayo Clinic

Publications and helpful links

The person responsible for entering information about the study voluntarily provides these publications. These may be about anything related to the study.

Helpful Links

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start (ACTUAL)

December 19, 2018

Primary Completion (ACTUAL)

December 15, 2020

Study Completion (ACTUAL)

December 15, 2020

Study Registration Dates

First Submitted

February 11, 2019

First Submitted That Met QC Criteria

February 13, 2019

First Posted (ACTUAL)

February 15, 2019

Study Record Updates

Last Update Posted (ACTUAL)

March 16, 2021

Last Update Submitted That Met QC Criteria

February 23, 2021

Last Verified

February 1, 2021

More Information

Terms related to this study

Keywords

Additional Relevant MeSH Terms

Other Study ID Numbers

  • 17-010544

Drug and device information, study documents

Studies a U.S. FDA-regulated drug product

Yes

Studies a U.S. FDA-regulated device product

No

product manufactured in and exported from the U.S.

No

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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