Atrial Fibrillation
Conditions
Keywords
Apixaban, Warfarin
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.
Interventions
DRUGApixaban
Dosage either 5mg or 2.5mg for 2 years
DRUGWarfarin
Dosage assessed by your treating physician for 2 years
Sponsors
Pfizer
Bristol-Myers Squibb
Mayo Clinic
Study design
Allocation
RANDOMIZED
Intervention model
PARALLEL
Primary purpose
OTHER
Masking
SINGLE (Outcomes Assessor)
Eligibility
Sex/Gender
ALL
Age
60 Years to No maximum
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
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| Standardized Neurocognitive Function Score | Baseline, Year 1, Year 2 | Assess the change in cognitive function using standardized neurocognitive assessment. |
| MRI Evidence of Silent Cerebral Infarct | Baseline, Year 2 | Magnetic Resonance Imagining of the brain to assess the development of new silent cerebral infarcts. |
| 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 |
Countries
United States
Participant flow
Participants by arm
| Arm | Count |
|---|---|
| Eliquis Apixaban: Dosage either 5mg or 2.5mg for 2 years | 18 |
| Warfarin Warfarin: Dosage assessed by your treating physician for 2 years | 16 |
| Total | 34 |
Withdrawals & dropouts
| Period | Reason | FG000 | FG001 |
|---|---|---|---|
| Overall Study | Withdrawal by Subject | 1 | 0 |
Baseline characteristics
| Characteristic | Warfarin | Total | Eliquis |
|---|---|---|---|
| Age, Continuous | 76.4 years STANDARD_DEVIATION 5.61 | 76.9 years STANDARD_DEVIATION 5.72 | 77.4 years STANDARD_DEVIATION 5.84 |
| Race and Ethnicity Not Collected | — | 0 Participants | — |
| Region of Enrollment United States | 16 participants | 34 participants | 18 participants |
| Sex: Female, Male Female | 9 Participants | 16 Participants | 7 Participants |
| Sex: Female, Male Male | 7 Participants | 18 Participants | 11 Participants |
Adverse events
| Event type | EG000 affected / at risk | EG001 affected / at risk |
|---|---|---|
| deaths Total, all-cause mortality | 0 / 18 | 0 / 16 |
| other Total, other adverse events | 0 / 18 | 0 / 16 |
| serious Total, serious adverse events | 0 / 18 | 0 / 16 |
Outcome results
Primary
MRI Evidence of New Cerebral Micro-bleeds
Magnetic Resonance Imagining of the brain to assess the development of new cerebral micro-bleeds
Time frame: Baseline, Year 2
Population: Study terminated due to slower than anticipated enrollment. Data was not collected or analyzed.
Primary
MRI Evidence of Silent Cerebral Infarct
Magnetic Resonance Imagining of the brain to assess the development of new silent cerebral infarcts.
Time frame: Baseline, Year 2
Population: Study terminated due to slower than anticipated enrollment. Data was not collected or analyzed.
Primary
Standardized Neurocognitive Function Score
Assess the change in cognitive function using standardized neurocognitive assessment.
Time frame: Baseline, Year 1, Year 2
Population: Study terminated due to slower than anticipated enrollment. Data was not collected or analyzed.