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Trial record 32 of 734 for:    warfarin

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

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ClinicalTrials.gov Identifier: NCT03839355
Recruitment Status : Recruiting
First Posted : February 15, 2019
Last Update Posted : February 15, 2019
Sponsor:
Collaborators:
Pfizer
Bristol-Myers Squibb
Information provided by (Responsible Party):
Malini Madhavan, Mayo Clinic

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
Atrial Fibrillation Drug: Apixaban Drug: Warfarin Phase 3

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Study Type : Interventional  (Clinical Trial)
Estimated Enrollment : 280 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 : December 19, 2018
Estimated Primary Completion Date : December 2022
Estimated Study Completion Date : December 2022

Resource links provided by the National Library of Medicine


Arm Intervention/treatment
Active Comparator: Eliquis Drug: Apixaban
Dosage either 5mg or 2.5mg for 2 years
Other Name: Eliquis

Active Comparator: Warfarin Drug: Warfarin
Dosage assessed by your treating physician for 2 years
Other Name: Coumadin




Primary Outcome Measures :
  1. Standardized neurocognitive function score [ Time Frame: Baseline, Year 1, Year 2 ]
    Assess the change in cognitive function using standardized neurocognitive assessment.

  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.

  3. 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



Information from the National Library of Medicine

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Ages Eligible for Study:   60 Years and older   (Adult, Older Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No
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

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT03839355


Locations
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United States, Minnesota
Mayo Clinic in Rochester Recruiting
Rochester, Minnesota, United States, 55905
Contact: Amanda Miner    507-255-8717    miner.amanda1@mayo.edu   
Principal Investigator: Malini Madhavan         
Sponsors and Collaborators
Mayo Clinic
Pfizer
Bristol-Myers Squibb
Investigators
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Principal Investigator: Malini Madhavan Mayo Clinic

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Responsible Party: Malini Madhavan, Principal Investigator, Mayo Clinic
ClinicalTrials.gov Identifier: NCT03839355     History of Changes
Other Study ID Numbers: 17-010544
First Posted: February 15, 2019    Key Record Dates
Last Update Posted: February 15, 2019
Last Verified: February 2019

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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, Mayo Clinic:
Apixaban
Warfarin
Additional relevant MeSH terms:
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Warfarin
Cerebral Infarction
Atrial Fibrillation
Arrhythmias, Cardiac
Heart Diseases
Cardiovascular Diseases
Pathologic Processes
Brain Infarction
Brain Ischemia
Cerebrovascular Disorders
Brain Diseases
Central Nervous System Diseases
Nervous System Diseases
Stroke
Vascular Diseases
Apixaban
Anticoagulants
Factor Xa Inhibitors
Antithrombins
Serine Proteinase Inhibitors
Protease Inhibitors
Enzyme Inhibitors
Molecular Mechanisms of Pharmacological Action