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

Primary Purpose

Atrial Fibrillation

Status
Terminated
Phase
Phase 3
Locations
United States
Study Type
Interventional
Intervention
Apixaban
Warfarin
Sponsored by
Mayo Clinic
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional other trial for Atrial Fibrillation focused on measuring Apixaban, Warfarin

Eligibility Criteria

60 Years - undefined (Adult, Older Adult)All SexesDoes not accept healthy volunteers

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

Sites / Locations

  • Mayo Clinic in Rochester

Arms of the Study

Arm 1

Arm 2

Arm Type

Active Comparator

Active Comparator

Arm Label

Eliquis

Warfarin

Arm Description

Outcomes

Primary Outcome Measures

Standardized Neurocognitive Function Score
Assess the change in cognitive function using standardized neurocognitive assessment.
MRI Evidence of Silent Cerebral Infarct
Magnetic Resonance Imagining of the brain to assess the development of new silent cerebral infarcts.
MRI Evidence of New Cerebral Micro-bleeds
Magnetic Resonance Imagining of the brain to assess the development of new cerebral micro-bleeds

Secondary Outcome Measures

Full Information

First Posted
February 11, 2019
Last Updated
February 23, 2021
Sponsor
Mayo Clinic
Collaborators
Pfizer, Bristol-Myers Squibb
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1. Study Identification

Unique Protocol Identification Number
NCT03839355
Brief Title
Trial of Apixaban vs Warfarin in Reducing Rate of Cognitive Decline, Silent Cerebral Infarcts and Cerebral Microbleeds in Patients With Atrial Fibrillation
Acronym
ARISTA
Official Title
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
Interventional

2. Study Status

Record Verification Date
February 2021
Overall Recruitment Status
Terminated
Why Stopped
Study terminated due to slower than anticipated enrollment.
Study Start Date
December 19, 2018 (Actual)
Primary Completion Date
December 15, 2020 (Actual)
Study Completion Date
December 15, 2020 (Actual)

3. Sponsor/Collaborators

Responsible Party, by Official Title
Principal Investigator
Name of the Sponsor
Mayo Clinic
Collaborators
Pfizer, Bristol-Myers Squibb

4. Oversight

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
Data Monitoring Committee
Yes

5. Study Description

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.

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Atrial Fibrillation
Keywords
Apixaban, Warfarin

7. Study Design

Primary Purpose
Other
Study Phase
Phase 3
Interventional Study Model
Parallel Assignment
Masking
Outcomes Assessor
Allocation
Randomized
Enrollment
34 (Actual)

8. Arms, Groups, and Interventions

Arm Title
Eliquis
Arm Type
Active Comparator
Arm Title
Warfarin
Arm Type
Active Comparator
Intervention Type
Drug
Intervention Name(s)
Apixaban
Other Intervention Name(s)
Eliquis
Intervention Description
Dosage either 5mg or 2.5mg for 2 years
Intervention Type
Drug
Intervention Name(s)
Warfarin
Other Intervention Name(s)
Coumadin
Intervention Description
Dosage assessed by your treating physician for 2 years
Primary Outcome Measure Information:
Title
Standardized Neurocognitive Function Score
Description
Assess the change in cognitive function using standardized neurocognitive assessment.
Time Frame
Baseline, Year 1, Year 2
Title
MRI Evidence of Silent Cerebral Infarct
Description
Magnetic Resonance Imagining of the brain to assess the development of new silent cerebral infarcts.
Time Frame
Baseline, Year 2
Title
MRI Evidence of New Cerebral Micro-bleeds
Description
Magnetic Resonance Imagining of the brain to assess the development of new cerebral micro-bleeds
Time Frame
Baseline, Year 2

10. Eligibility

Sex
All
Minimum Age & Unit of Time
60 Years
Accepts Healthy Volunteers
No
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
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Malini Madhavan
Organizational Affiliation
Mayo Clinic
Official's Role
Principal Investigator
Facility Information:
Facility Name
Mayo Clinic in Rochester
City
Rochester
State/Province
Minnesota
ZIP/Postal Code
55905
Country
United States

12. IPD Sharing Statement

Links:
URL
https://www.mayo.edu/research/clinical-trials
Description
Mayo Clinic Clinical Trials

Learn more about this trial

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

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