18 and older, any sex, with Non-valvular Atrial Fibrillation. Patients with the condition only — healthy volunteers not accepted.
Results — posted to ClinicalTrials.gov
Per-arm endpoint measurements with 95% confidence intervals where reported. Source: trial results section.
Percentage of Days With a Correct Execution of the Apixaban Dosing RegimenPrimary· Day 1 up to week 24
The mean percentage of days which participants maintained adherence to apixaban treatment was measured for each arm. Adherence to apixaban = number of units of adherence \*100 / total number of eligible days for the time period from first dose date, up to 169 days. Unit of adherence: A 24-hour window where the treatment is taken as prescribed, ie, 1 tablet (5 mg or 2.5 mg, as appropriate) 2 times a day. If only one dose is missed in 24-hours, it is still considered as a unit of adherence. Adherence up to 24 weeks was calculated as the percentage of adherence units within that period. If a part
Group
Value
95% CI
Apixaban (Primary SOC Information)
91.64
± 17.143
Apixaban (Additional Educational Program)
91.88
± 16.140
Percentage of Days With a Correct Execution of the Apixaban Dosing Regimen During the 12 to 24 Weeks Period Compared With During the First 12 WeeksSecondary· Day 1 to Week 12, Week 12 to Week 24
The mean adherence to apixaban treatment during the first 24 weeks was measured between the standard of care (SOC) information and Additional Education Program (AEP) arms and expressed as a percentage. Adherence to Apixaban = number of units of adherence \*100 / total number of eligible days for the time period.
Day 1 to Week 12
Group
Value
95% CI
Apixaban (Primary SOC Information)
93.7
± 14.18
Apixaban (Additional Educational Program)
93.0
± 15.71
Week 12 to Week 24
Group
Value
95% CI
Apixaban (Primary SOC Information)
90.3
± 20.64
Apixaban (Additional Educational Program)
90.9
± 18.36
Percentage of Days With a Correct Execution of the Apixaban Dosing Regimen During the 24 to 48 Weeks PeriodSecondary· Week 24 to Week 48
The mean percentage of days which participants maintained adherence to apixaban treatment was measured for each arm. Adherence to apixaban = number of units of adherence \*100 / total number of eligible days for the time period from first dose date, up to 169 days. Unit of adherence: A 24-hour window where the treatment is taken as prescribed, ie, 1 tablet (5 mg or 2.5 mg, as appropriate) 2 times a day. If only one dose is missed in 24-hours, it is still considered as a unit of adherence. Adherence over 24 weeks was calculated as the percentage of adherence units within that period. If a parti
Group
Value
95% CI
Apixaban (Primary SOC Information)
87.59
± 22.921
Apixaban (Additional Educational Program)
88.41
± 22.148
Apixaban (Secondary SOC)
87.51
± 21.125
Non-adherence Predictors of 20% or More (vs. at Least 80% Adherence) at 24 WeeksSecondary· Week 24
Logit analyses were conducted on the Primary Efficacy Set to identify non-adherence predictors of 20% or more (vs. at least 80% adherence) at 24 weeks. In the Primary SOC group, alcohol use, Mini-Mental State Evaluation (MMSE) score, UK standard occupational classification, and type of atrial fibrillation were retained in the model (p-value \<= 0.2). In the Additional Educational Program group, alcohol use, type of atrial fibrillation, age and Vitamin K Antagonists (VKA) status were retained in the model (p-value \<= 0.2). Odds ratios are presented for predictors of non-adherence.
<=2 Alcoholic Drink/Day Average vs None
Group
Value
95% CI
Apixaban (Primary SOC Information)
1.251
0.691 – 2.265
Apixaban (Additional Educational Program)
0.994
0.558 – 1.682
>=3 Alcoholic Drink/Day Average vs None
Group
Value
95% CI
Apixaban (Primary SOC Information)
4.268
1.226 – 14.859
Apixaban (Additional Educational Program)
3.782
0.884 – 16.178
Mini-mental state examination score
Group
Value
95% CI
Apixaban (Primary SOC Information)
0.808
0.686 – 0.952
Apixaban (Additional Educational Program)
NA
NA – NA
Higher mgmt., adm. and professional jobs vs UKSOC1
Group
Value
95% CI
Apixaban (Primary SOC Information)
0.827
0.136 – 5.033
Apixaban (Additional Educational Program)
NA
NA – NA
Higher professional occupations vs UKSOC1
Group
Value
95% CI
Apixaban (Primary SOC Information)
0.898
0.197 – 4.091
Apixaban (Additional Educational Program)
NA
NA – NA
Intermediate occupations vs UKSOC1
Group
Value
95% CI
Apixaban (Primary SOC Information)
1.230
0.401 – 3.769
Apixaban (Additional Educational Program)
NA
NA – NA
Large employers and mgmt. and adm. jobs vs UKSOC1
Group
Value
95% CI
Apixaban (Primary SOC Information)
2.823
0.412 – 19.338
Apixaban (Additional Educational Program)
NA
NA – NA
Lower mgmt., adm. and professional jobs vs UKSOC1
Group
Value
95% CI
Apixaban (Primary SOC Information)
0.948
0.256 – 3.515
Apixaban (Additional Educational Program)
NA
NA – NA
Number of Participants With Serious Adverse Events (SAEs), Drug Related Adverse Events (AE), AE Leading to Discontinuation, and DeathSecondary· Day 1 up to week 24
AEs with onset date from day 1 through week 24 are included in this summary. AE=any new unfavorable symptom, sign, or disease or worsening of a preexisting condition that may not have a causal relationship with treatment. SAE=a medical event that at any dose results in death, persistent or significant disability/incapacity, or drug dependency/abuse; is life-threatening, an important medical event, or a congenital anomaly/birth defect; or requires or prolongs hospitalization. Treatment-related=having certain, probable, possible, or missing relationship to study drug.
SAE
Group
Value
95% CI
Apixaban (Primary SOC Information)
75
Apixaban (Additional Educational Program)
82
Drug related AE
Group
Value
95% CI
Apixaban (Primary SOC Information)
54
Apixaban (Additional Educational Program)
41
AE leading to discontinuation
Group
Value
95% CI
Apixaban (Primary SOC Information)
33
Apixaban (Additional Educational Program)
22
Death
Group
Value
95% CI
Apixaban (Primary SOC Information)
6
Apixaban (Additional Educational Program)
5
Number of Participants With Serious Adverse Events (SAEs), Drug Related Adverse Events (AE), AE Leading to Discontinuation, and DeathSecondary· Week 24 up to Week 48
Adverse events with onset date after 24 weeks are included in this summary. AE=any new unfavorable symptom, sign, or disease or worsening of a preexisting condition that may not have a causal relationship with treatment. SAE=a medical event that at any dose results in death, persistent or significant disability/incapacity, or drug dependency/abuse; is life-threatening, an important medical event, or a congenital anomaly/birth defect; or requires or prolongs hospitalization. Treatment-related=having certain, probable, possible, or missing relationship to study drug.
SAE
Group
Value
95% CI
Apixaban (Primary SOC Information)
71
Apixaban (Additional Educational Program)
43
Apixaban (Secondary SOC)
30
Drug related AE
Group
Value
95% CI
Apixaban (Primary SOC Information)
15
Apixaban (Additional Educational Program)
12
Apixaban (Secondary SOC)
10
AE leading to discontinuation
Group
Value
95% CI
Apixaban (Primary SOC Information)
14
Apixaban (Additional Educational Program)
3
Apixaban (Secondary SOC)
8
Death
Group
Value
95% CI
Apixaban (Primary SOC Information)
3
Apixaban (Additional Educational Program)
3
Apixaban (Secondary SOC)
6
Adverse events — posted to ClinicalTrials.gov
Time frame: From date of first dose to date of last dose plus 30 days.
Reporting threshold: 5%.
Adverse-event reports describe events observed during the trial — not all are caused by the drug.
Primary SOC (Period 1)
Serious: 69/604 (11%)
Deaths: —
Continued Additional Educational Program (CAEP) (Period 2)
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Publications: Europe PMC API search by NCT ID, retrieved 10 June 2026
Drug + disease cross-links: matched in real time against Drug Landscape's normalised drug + company + condition tables
Sponsor: as reported to ClinicalTrials.gov by Bristol-Myers Squibb
Last refreshed: 19 August 2019
Drug Landscape aggregates and links these public records for informational use only. Always verify against the primary source before clinical or regulatory decisions. Canonical URL: https://druglandscape.com/trial/NCT01884350.