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Study terminated due to slower than anticipated enrollment.
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| Name | Class |
|---|---|
| Pfizer | INDUSTRY |
| Bristol-Myers Squibb | INDUSTRY |
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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.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| Eliquis | Active Comparator |
| |
| Warfarin | Active Comparator |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| Apixaban | Drug | Dosage either 5mg or 2.5mg for 2 years |
|
|
| Measure | Description | Time Frame |
|---|---|---|
| Standardized Neurocognitive Function Score | Assess the change in cognitive function using standardized neurocognitive assessment. | Baseline, Year 1, Year 2 |
| MRI Evidence of Silent Cerebral Infarct | Magnetic Resonance Imagining of the brain to assess the development of new silent cerebral infarcts. | Baseline, Year 2 |
| 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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Inclusion Criteria:
Exclusion Criteria:
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| Name | Affiliation | Role |
|---|---|---|
| Malini Madhavan | Mayo Clinic | Principal Investigator |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| Mayo Clinic in Rochester | Rochester | Minnesota | 55905 | United States |
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| Label | URL |
|---|---|
| Mayo Clinic Clinical Trials | View source |
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| ID | Title | Description |
|---|---|---|
| FG000 | Eliquis | Apixaban: Dosage either 5mg or 2.5mg for 2 years |
| FG001 | Warfarin | Warfarin: Dosage assessed by your treating physician for 2 years |
| Title | Milestones | Reasons Not Completed | |||||
|---|---|---|---|---|---|---|---|
| Overall Study |
|
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| Type | Includes Protocol | Includes SAP | Includes ICF | Document Label | Document Date | Document Uploaded Date | Document File Name |
|---|---|---|---|---|---|---|---|
| Prot_SAP | Yes | Yes | No | Study Protocol and Statistical Analysis Plan | Dec 18, 2018 |
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| Warfarin | Drug | Dosage assessed by your treating physician for 2 years |
|
|
| COMPLETED |
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| NOT COMPLETED |
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|
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| ID | Title | Description |
|---|---|---|
| BG000 | Eliquis | Apixaban: Dosage either 5mg or 2.5mg for 2 years |
| BG001 | Warfarin | Warfarin: Dosage assessed by your treating physician for 2 years |
| BG002 | Total | Total of all reporting groups |
| Units | Counts |
|---|---|
| Participants |
|
| Title | Description | Population Description | Parameter Type | Dispersion Type | Unit of Measure | Calculate Percentage | Denominator Units Selected | Denominators | Classes | ||||||||||
|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|
| Age, Continuous | Mean | Standard Deviation | years |
| |||||||||||||||
| Sex: Female, Male | Count of Participants | Participants |
| ||||||||||||||||
| Race and Ethnicity Not Collected | Race and Ethnicity were not collected from any participant. | Count of Participants | Participants |
| |||||||||||||||
| Region of Enrollment | Number | participants |
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| Type | Title | Description | Population Description | Reporting Status | Anticipated Posting Date | Parameter Type | Dispersion Type | Unit of Measure | Calculate Percentage | Time Frame | Units Analyzed | Denominator Units Selected | Arm/Group Information | Denominators | Classes | Analyses | |||||||||||||
|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|
| Primary | Standardized Neurocognitive Function Score | Assess the change in cognitive function using standardized neurocognitive assessment. | Study terminated due to slower than anticipated enrollment. Data was not collected or analyzed. | Posted | 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. | Study terminated due to slower than anticipated enrollment. Data was not collected or analyzed. | Posted | 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 | Study terminated due to slower than anticipated enrollment. Data was not collected or analyzed. | Posted | Baseline, Year 2 |
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Adverse events were collected from baseline to end of treatment for approximately 24 months.
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| ID | Title | Description | Deaths (Affected) | Deaths (At Risk) | Serious Events (Affected) | Serious Events (At Risk) | Other Events (Affected) | Other Events (At Risk) |
|---|---|---|---|---|---|---|---|---|
| EG000 | Eliquis | Apixaban: Dosage either 5mg or 2.5mg for 2 years | 0 | 18 | 0 | 18 | 0 | 18 |
| EG001 | Warfarin | Warfarin: Dosage assessed by your treating physician for 2 years | 0 | 16 | 0 | 16 | 0 | 16 |
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| Title | Organization | Phone | Extension | |
|---|---|---|---|---|
| Dr. Malini Madhavan | Mayo Clinic | 507-255-4152 | Madhavan.Malini@mayo.edu |
| Jan 12, 2021 |
| Prot_SAP_000.pdf |
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| ID | Term |
|---|---|
| D001281 | Atrial Fibrillation |
| ID | Term |
|---|---|
| D001145 | Arrhythmias, Cardiac |
| D006331 | Heart Diseases |
| D002318 | Cardiovascular Diseases |
| D010335 | Pathologic Processes |
| D013568 | Pathological Conditions, Signs and Symptoms |
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| ID | Term |
|---|---|
| C522181 | apixaban |
| D014859 | Warfarin |
| ID | Term |
|---|---|
| D015110 | 4-Hydroxycoumarins |
| D003374 | Coumarins |
| D001578 | Benzopyrans |
| D011714 | Pyrans |
| D006573 | Heterocyclic Compounds, 1-Ring |
| D006571 | Heterocyclic Compounds |
| D006574 | Heterocyclic Compounds, 2-Ring |
| D000072471 | Heterocyclic Compounds, Fused-Ring |
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