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

Phase 3

Terminated

• Conditions: Atrial Fibrillation
• Interventions: Drug: Apixaban; Drug: Warfarin

• Registration Number: NCT03839355
• Lead Sponsor: 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.

Detailed Description

Not available

Study Timeline

• Study Start: 2018-12-19
• Study First Submitted: 2019-02-11
• Study First Submitted QC: 2019-02-13
• Study First Posted: 2019-02-15
• Primary Completion: 2020-12-15
• Study Completion: 2020-12-15
• Status Verified: 2021-02
• Results First Submitted: 2021-02-05
• Results First Submitted QC: 2021-02-23
• Last Update Submitted: 2021-02-23
• Results First Posted: 2021-03-16
• Last Update Posted: 2021-03-16

Recruitment & Eligibility

• Status: TERMINATED
• Sex: All
• Target Recruitment: 34

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

• Study Type: INTERVENTIONAL
• Study Design: PARALLEL

Arm && Interventions

Group	Intervention	Description
Eliquis	Apixaban	-
Warfarin	Warfarin	-

Primary Outcome Measures

Name	Time	Method
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
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.

Trial Locations

Locations (1)

Mayo Clinic in Rochester; 🇺🇸 Rochester, Minnesota, United States