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Clinical Trial Details — Status: Terminated

Administrative data

NCT number NCT03839355
Other study ID # 17-010544
Secondary ID
Status Terminated
Phase Phase 3
First received
Last updated
Start date December 19, 2018
Est. completion date December 15, 2020

Study information

Verified date February 2021
Source Mayo Clinic
Contact n/a
Is FDA regulated No
Health authority
Study type Interventional

Clinical Trial 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.


Recruitment information / eligibility

Status Terminated
Enrollment 34
Est. completion date December 15, 2020
Est. primary completion date December 15, 2020
Accepts healthy volunteers No
Gender All
Age group 60 Years and older
Eligibility 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

Study Design


Related Conditions & MeSH terms


Intervention

Drug:
Apixaban
Dosage either 5mg or 2.5mg for 2 years
Warfarin
Dosage assessed by your treating physician for 2 years

Locations

Country Name City State
United States Mayo Clinic in Rochester Rochester Minnesota

Sponsors (3)

Lead Sponsor Collaborator
Mayo Clinic Bristol-Myers Squibb, Pfizer

Country where clinical trial is conducted

United States, 

Outcome

Type Measure Description Time frame Safety issue
Primary Standardized Neurocognitive Function Score Assess the change in cognitive function using standardized neurocognitive assessment. Baseline, Year 1, Year 2
Primary MRI Evidence of Silent Cerebral Infarct Magnetic Resonance Imagining of the brain to assess the development of new silent cerebral infarcts. Baseline, Year 2
Primary MRI Evidence of New Cerebral Micro-bleeds Magnetic Resonance Imagining of the brain to assess the development of new cerebral micro-bleeds Baseline, Year 2
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