Trial Outcomes & Findings for Trial of Apixaban vs Warfarin in Reducing Rate of Cognitive Decline, Silent Cerebral Infarcts and Cerebral Microbleeds in Patients With Atrial Fibrillation (NCT NCT03839355)

Results Overview

Assess the change in cognitive function using standardized neurocognitive assessment.

Recruitment status

TERMINATED

Study phase

PHASE3

Target enrollment

34 participants

Primary outcome timeframe

Baseline, Year 1, Year 2

Results posted on

2021-03-16

Participant Flow

Participant milestones

Participant milestones
Measure	Eliquis Apixaban: Dosage either 5mg or 2.5mg for 2 years	Warfarin Warfarin: Dosage assessed by your treating physician for 2 years
Overall Study STARTED	18	16
Overall Study COMPLETED	17	16
Overall Study NOT COMPLETED	1	0

Reasons for withdrawal

Reasons for withdrawal
Measure	Eliquis Apixaban: Dosage either 5mg or 2.5mg for 2 years	Warfarin Warfarin: Dosage assessed by your treating physician for 2 years
Overall Study Withdrawal by Subject	1	0

Baseline Characteristics

Race and Ethnicity were not collected from any participant.

Baseline characteristics by cohort

Baseline characteristics by cohort
Measure	Eliquis n=18 Participants Apixaban: Dosage either 5mg or 2.5mg for 2 years	Warfarin n=16 Participants Warfarin: Dosage assessed by your treating physician for 2 years	Total n=34 Participants Total of all reporting groups
Age, Continuous	77.4 years STANDARD_DEVIATION 5.84 • n=18 Participants	76.4 years STANDARD_DEVIATION 5.61 • n=16 Participants	76.9 years STANDARD_DEVIATION 5.72 • n=34 Participants
Sex: Female, Male Female	7 Participants n=18 Participants	9 Participants n=16 Participants	16 Participants n=34 Participants
Sex: Female, Male Male	11 Participants n=18 Participants	7 Participants n=16 Participants	18 Participants n=34 Participants
Race and Ethnicity Not Collected	—	—	0 Participants Race and Ethnicity were not collected from any participant.
Region of Enrollment United States	18 participants n=18 Participants	16 participants n=16 Participants	34 participants n=34 Participants

PRIMARY outcome

Timeframe: Baseline, Year 1, Year 2

Population: Study terminated due to slower than anticipated enrollment. Data was not collected or analyzed.

Assess the change in cognitive function using standardized neurocognitive assessment.

Outcome measures

Outcome data not reported

PRIMARY outcome

Timeframe: Baseline, Year 2

Population: Study terminated due to slower than anticipated enrollment. Data was not collected or analyzed.

Magnetic Resonance Imagining of the brain to assess the development of new silent cerebral infarcts.

Outcome measures

Outcome data not reported

PRIMARY outcome

Timeframe: Baseline, Year 2

Population: Study terminated due to slower than anticipated enrollment. Data was not collected or analyzed.

Magnetic Resonance Imagining of the brain to assess the development of new cerebral micro-bleeds

Outcome measures

Outcome data not reported

Adverse Events

Eliquis

Serious events: 0 serious events

Other events: 0 other events

Deaths: 0 deaths

Warfarin

Serious events: 0 serious events

Other events: 0 other events

Deaths: 0 deaths

Serious adverse events

Adverse event data not reported

Other adverse events

Adverse event data not reported

Additional Information

Dr. Malini Madhavan

Mayo Clinic

Phone: 507-255-4152

Email: [email protected]

Results disclosure agreements

Principal investigator is a sponsor employee
Publication restrictions are in place