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

Mayo Clinic

Status and phase

Terminated

Phase 3

Conditions

Atrial Fibrillation

Treatments

Drug: Apixaban

Drug: Warfarin

Study type

Interventional

Funder types

Other

Industry

Identifiers

NCT03839355

17-010544

Details and patient eligibility

About

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.

Enrollment

34 patients

Sex

All

Ages

60+ years old

Volunteers

No 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