Clincosm LogoSign in Get a demo

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

Sponsor
Mayo Clinic (Other)
Overall Status
Terminated
CT.gov ID
NCT03839355
Collaborator
Pfizer (Industry), Bristol-Myers Squibb (Industry)
34
Enrollment
1
Location
2
Arms
23.9
Actual Duration (Months)
1.4
Patients Per Site Per Month

Study Details

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.

Condition or Disease Intervention/Treatment Phase
Phase 3

Study Design

Study Type:
Interventional
Actual Enrollment :
34 participants
Allocation:
Randomized
Intervention Model:
Parallel Assignment
Masking:
Single (Outcomes Assessor)
Primary Purpose:
Other
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
Actual Study Start Date :
Dec 19, 2018
Actual Primary Completion Date :
Dec 15, 2020
Actual Study Completion Date :
Dec 15, 2020

Arms and Interventions

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

    		•

    Outcome Measures

    Primary Outcome Measures

    1. Standardized Neurocognitive Function Score [Baseline, Year 1, Year 2]

      Assess the change in cognitive function using standardized neurocognitive assessment.

    2. MRI Evidence of Silent Cerebral Infarct [Baseline, Year 2]

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

    3. MRI Evidence of New Cerebral Micro-bleeds [Baseline, Year 2]

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

    Eligibility Criteria

    Criteria

    Ages Eligible for Study:
    60 Years and Older
    Sexes Eligible for Study:
    All
    Accepts Healthy Volunteers:
    No
    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

    Contacts and Locations

    Locations

    Site City State Country Postal Code
    1 Mayo Clinic in Rochester Rochester Minnesota United States 55905

    Sponsors and Collaborators

    • Mayo Clinic
    • Pfizer
    • Bristol-Myers Squibb

    Investigators

    • Principal Investigator: Malini Madhavan, Mayo Clinic

    Study Documents (Full-Text)

    More Information

    Additional Information:

    Publications

    None provided.
    Responsible Party:
    Malini Madhavan, Principal Investigator, Mayo Clinic
    ClinicalTrials.gov Identifier:
    NCT03839355
    Other Study ID Numbers:
    • 17-010544
    First Posted:
    Feb 15, 2019
    Last Update Posted:
    Mar 16, 2021
    Last Verified:
    Feb 1, 2021
    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
    Keywords provided by Malini Madhavan, Principal Investigator, Mayo Clinic
    Apixaban
    Warfarin
    Additional relevant MeSH terms:
    Cerebral Infarction
    Atrial Fibrillation
    Warfarin
    Apixaban

    Study Results

    Participant Flow

    Recruitment Details
    Pre-assignment Detail
    Arm/Group Title Eliquis Warfarin
    Arm/Group Description Apixaban: Dosage either 5mg or 2.5mg for 2 years Warfarin: Dosage assessed by your treating physician for 2 years
    Period Title: Overall Study
    STARTED 18 16
    COMPLETED 17 16
    NOT COMPLETED 1 0

    Baseline Characteristics

    Arm/Group Title Eliquis Warfarin Total
    Arm/Group Description Apixaban: Dosage either 5mg or 2.5mg for 2 years Warfarin: Dosage assessed by your treating physician for 2 years Total of all reporting groups
    Overall Participants 18 16 34
    Age (years) [Mean (Standard Deviation) ]
    Mean (Standard Deviation) [years]
    77.4
    (5.84)
    76.4
    (5.61)
    76.9
    (5.72)
    Sex: Female, Male (Count of Participants)
    Female
    7
    38.9%
    9
    56.3%
    16
    47.1%
    Male
    11
    61.1%
    7
    43.8%
    18
    52.9%
    Race and Ethnicity Not Collected (Count of Participants)
    Count of Participants [Participants]
    0
    0%
    Region of Enrollment (participants) [Number]
    United States
    18
    100%
    16
    100%
    34
    100%

    Outcome Measures

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

    Outcome Measure Data

    Analysis Population Description
    Study terminated due to slower than anticipated enrollment. Data was not collected or analyzed.
    Arm/Group Title Eliquis Warfarin
    Arm/Group Description Apixaban: Dosage either 5mg or 2.5mg for 2 years Warfarin: Dosage assessed by your treating physician for 2 years
    Measure Participants 0 0
    2. Primary Outcome
    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

    Outcome Measure Data

    Analysis Population Description
    Study terminated due to slower than anticipated enrollment. Data was not collected or analyzed.
    Arm/Group Title Eliquis Warfarin
    Arm/Group Description Apixaban: Dosage either 5mg or 2.5mg for 2 years Warfarin: Dosage assessed by your treating physician for 2 years
    Measure Participants 0 0
    3. Primary Outcome
    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

    Outcome Measure Data

    Analysis Population Description
    Study terminated due to slower than anticipated enrollment. Data was not collected or analyzed.
    Arm/Group Title Eliquis Warfarin
    Arm/Group Description Apixaban: Dosage either 5mg or 2.5mg for 2 years Warfarin: Dosage assessed by your treating physician for 2 years
    Measure Participants 0 0

    Adverse Events

    Time Frame Adverse events were collected from baseline to end of treatment for approximately 24 months.
    Adverse Event Reporting Description
    Arm/Group Title Eliquis Warfarin
    Arm/Group Description Apixaban: Dosage either 5mg or 2.5mg for 2 years Warfarin: Dosage assessed by your treating physician for 2 years
    All Cause Mortality
    Eliquis Warfarin
    Affected / at Risk (%) # Events Affected / at Risk (%) # Events
    Total 0/18 (0%) 0/16 (0%)
    Serious Adverse Events
    Eliquis Warfarin
    Affected / at Risk (%) # Events Affected / at Risk (%) # Events
    Total 0/18 (0%) 0/16 (0%)
    Other (Not Including Serious) Adverse Events
    Eliquis Warfarin
    Affected / at Risk (%) # Events Affected / at Risk (%) # Events
    Total 0/18 (0%) 0/16 (0%)

    Limitations/Caveats

    [Not Specified]

    More Information

    Certain Agreements

    All Principal Investigators ARE employed by the organization sponsoring the study.

    There is NOT an agreement between Principal Investigators and the Sponsor (or its agents) that restricts the PI's rights to discuss or publish trial results after the trial is completed.

    Results Point of Contact

    Name/Title Dr. Malini Madhavan
    Organization Mayo Clinic
    Phone 507-255-4152
    Email Madhavan.Malini@mayo.edu
    Responsible Party:
    Malini Madhavan, Principal Investigator, Mayo Clinic
    ClinicalTrials.gov Identifier:
    NCT03839355
    Other Study ID Numbers:
    • 17-010544
    First Posted:
    Feb 15, 2019
    Last Update Posted:
    Mar 16, 2021
    Last Verified:
    Feb 1, 2021