Status:
TERMINATED
Trial of Apixaban vs Warfarin in Reducing Rate of Cognitive Decline, Silent Cerebral Infarcts and Cerebral Microbleeds in Patients With Atrial Fibrillation
Lead Sponsor:
Mayo Clinic
Collaborating Sponsors:
Pfizer
Bristol-Myers Squibb
Conditions:
Atrial Fibrillation
Eligibility:
All Genders
60+ years
Phase:
PHASE3
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 inve...
Eligibility Criteria
Inclusion
- 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
- 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
Key Trial Info
Start Date :
December 19 2018
Trial Type :
INTERVENTIONAL
Allocation :
ACTUAL
End Date :
December 15 2020
Estimated Enrollment :
34 Patients enrolled
Trial Details
Trial ID
NCT03839355
Start Date
December 19 2018
End Date
December 15 2020
Last Update
March 16 2021
Active Locations (1)
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1
Mayo Clinic in Rochester
Rochester, Minnesota, United States, 55905