N/A
Completed N=193,565
Safety and Effectiveness of Apixaban Compared to Warfarin in Secondary Prevention in Patients With Atrial Fibrillation
Source: ClinicalTrials.gov NCT05321810 ↗Enrolled (actual)
193,565
Serious AEs
—
Results posted
Jan 2024
Primary outcomePrimary: Incidence Rate of a Composite of Recurrent Stroke or Systemic Embolism (SE) During the Follow-up Period: Secondary Prevention (Balanced) Cohort — 41.217; 50.581 Events Per 1000 Participant-Years
Summary
The purpose of this study are 1) to characterize the primary and secondary prevention patients, 2) to calculate incidence rates of stroke/SE or major bleeding in each cohort and 3) to investigate for Japanese secondary prevention patients as Real World Evidence (RWE) on the effectiveness and safety of apixaban compared to warfarin in patients with non-valvular atrial fibrillation (NVAF).
Outcome Measures
| Outcome | Result | p-value |
|---|---|---|
| PRIMARY Incidence Rate of a Composite of Recurrent Stroke or Systemic Embolism (SE) During the Follow-up Period: Secondary Prevention (Balanced) Cohort |
41.217; 50.581 | — |
| PRIMARY Time Course of Proportion of the Incidence of a Composite of Recurrent Stroke or Systemic Embolism (SE)-Free Participants at 0 Month: Secondary Prevention (Balanced) Cohorts |
1.000; 1.000 | — |
| PRIMARY Time Course of Proportion of the Incidence of a Composite of Recurrent Stroke or Systemic Embolism (SE)-Free Participants at 6 Months: Secondary Prevention (Balanced) Cohorts |
0.971; 0.967 | — |
| PRIMARY Time Course of Proportion of the Incidence of a Composite of Recurrent Stroke or Systemic Embolism (SE)-Free Participants at 12 Months: Secondary Prevention (Balanced) Cohorts |
0.953; 0.948 | — |
| PRIMARY Time Course of Proportion of the Incidence of a Composite of Recurrent Stroke or Systemic Embolism (SE)-Free Participants at 18 Months: Secondary Prevention (Balanced) Cohorts |
0.942; 0.932 | — |
| PRIMARY Time Course of Proportion of the Incidence of a Composite of Recurrent Stroke or Systemic Embolism (SE)-Free Participants at 24 Months: Secondary Prevention (Balanced) Cohorts |
0.933; 0.915 | 0.016 sig |
| PRIMARY Number of Participants With Risk of a Composite of Recurrent Stroke or SE at 0 Month: Secondary Prevention (Balanced) Cohorts |
7796; 11601 | — |
| PRIMARY Number of Participants With Risk of a Composite of Recurrent Stroke or SE at 6 Months: Secondary Prevention (Balanced) Cohorts |
2061; 2393 | — |
| PRIMARY Number of Participants With Risk of a Composite of Recurrent Stroke or SE at 12 Months: Secondary Prevention (Balanced) Cohorts |
1426; 1670 | — |
| PRIMARY Number of Participants With Risk of a Composite of Recurrent Stroke or SE at 18 Months: Secondary Prevention (Balanced) Cohorts |
1095; 1272 | — |
| PRIMARY Number of Participants With Risk of a Composite of Recurrent Stroke or SE at 24 Months: Secondary Prevention (Balanced) Cohorts |
845; 1024 | 0.013 sig |
| PRIMARY Incidence Rate of Major Bleeding During the Follow-up Period: Secondary Prevention (Balanced) Cohorts |
28.351; 39.083 | — |
| PRIMARY Time Course of Proportion of Incidence of Major Bleeding-Free Participants at 0 Month: Secondary Prevention (Balanced) Cohorts |
1.000; 1.000 | — |
| PRIMARY Time Course of Proportion of Incidence of Major Bleeding-Free Participants at 6 Months: Secondary Prevention (Balanced) Cohorts |
0.983; 0.976 | — |
| PRIMARY Time Course of Proportion of Incidence of Major Bleeding-Free Participants at 12 Months: Secondary Prevention (Balanced) Cohorts |
0.968; 0.963 | — |
| PRIMARY Time Course of Proportion of Incidence of Major Bleeding-Free Participants at 18 Months: Secondary Prevention (Balanced) Cohorts |
0.958; 0.949 | — |
| PRIMARY Time Course of Proportion of Incidence of Major Bleeding-Free Participants at 24 Months: Secondary Prevention (Balanced) Cohorts |
0.948; 0.932 | 0.002 sig |
| PRIMARY Number of Participants With Risk of Major Bleeding at 0 Month: Secondary Prevention (Balanced) Cohorts |
7796; 11601 | — |
| PRIMARY Number of Participants With Risk of Major Bleeding at 6 Months: Secondary Prevention (Balanced) Cohorts |
2081; 2412 | — |
| PRIMARY Number of Participants With Risk of Major Bleeding at 12 Months: Secondary Prevention (Balanced) Cohorts |
1448; 1685 | — |
| PRIMARY Number of Participants With Risk of Major Bleeding at 18 Months: Secondary Prevention (Balanced) Cohorts |
1110; 1283 | — |
| PRIMARY Number of Participants With Risk of Major Bleeding at 24 Months: Secondary Prevention (Balanced) Cohorts |
850; 1028 | 0.001 sig |
| SECONDARY Incidence Rate of Recurrent Cardiogenic Cerebral Embolism During the Follow-up Period: Secondary Prevention (Balanced) Cohorts |
10.355; 17.893 | — |
| SECONDARY Time Course of Proportion of Incidence of Recurrent Cardiogenic Cerebral Embolism-Free Participants: Secondary Prevention (Balanced) Cohorts |
1.000; 1.000; 0.991; 0.989; 0.988; 0.981 | <0.001 sig |
| SECONDARY Number of Participants With Risk of Recurrent Cardiogenic Cerebral Embolism: Secondary Prevention (Balanced) Cohorts |
7796; 11601; 2088; 2427; 1460; 1701 | <0.001 sig |
| SECONDARY Incidence Rate of Recurrent Cerebral Infarction During the Follow-up Period: Secondary Prevention (Balanced) Cohorts |
15.481; 13.430 | — |
| SECONDARY Time Course of Proportion of Incidence of Recurrent Cerebral Infarction-Free Participants: Secondary Prevention (Balanced) Cohorts |
1.000; 1.000; 0.990; 0.989; 0.981; 0.984 | 0.350 |
| SECONDARY Number of Participants With Risk of Recurrent Cerebral Infarction: Secondary Prevention (Balanced) Cohorts |
7796; 11601; 2082; 2414; 1447; 1691 | 0.324 |
| SECONDARY Incidence Rate of Intracranial Hemorrhage During the Follow-up Period: Secondary Prevention (Balanced) Cohorts |
38.214; 44.868 | — |
| SECONDARY Time Course of Proportion of Incidence of Intracranial Hemorrhage-Free Participants: Secondary Prevention (Balanced) Cohorts |
1.000; 1.000; 0.974; 0.969; 0.959; 0.958 | 0.111 |
| SECONDARY Number of Participants With Risk of Intracranial Hemorrhage: Secondary Prevention (Balanced) Cohorts |
7796; 11601; 2069; 2401; 1434; 1675 | 0.100 |
| SECONDARY Incidence Rate of Gastrointestinal Bleeding During the Follow-up Period: Secondary Prevention (Balanced) Cohorts |
47.634; 47.876 | — |
| SECONDARY Time Course of Proportion of Incidence of Gastrointestinal Bleeding-Free Participants: Secondary Prevention (Balanced) Cohorts |
1.000; 1.000; 0.969; 0.968; 0.953; 0.954 | 0.979 |
| SECONDARY Number of Participants With Risk of Gastrointestinal Bleeding: Secondary Prevention (Balanced) Cohorts |
7796; 11601; 2047; 2381; 1424; 1664 | 0.978 |
| SECONDARY Incidence Rate of Intraocular Bleeding During the Follow-up Period: Secondary Prevention (Balanced) Cohorts |
3.748; 8.627 | — |
| SECONDARY Time Course of Proportion of Incidence of Intraocular Bleeding-Free Participants: Secondary Prevention (Balanced) Cohorts |
1.000; 1.000; 0.998; 0.995; 0.995; 0.991 | <0.001 sig |
| SECONDARY Number of Participants With Risk of Intraocular Bleeding: Secondary Prevention (Balanced) Cohorts |
7796; 11601; 2097; 2428; 1462; 1691 | <0.001 sig |
Eligibility Criteria
Inclusion Criteria
Patients must meet all the following selection criteria
- Patients registered in the Medical Data Vision (MDV) database 2008 though 2021.
- Patients newly with non-valvular atrial fibrillation
- Patients who newly receive warfarin or apixaban after diagnosis of NVAF
- Age 20 years or older on the index date
- Patients who have a history of stroke or transient ischemic attack (TIA) are inclusion criteria only for secondary prevention cohort, otherwise patients will be concluded in the primary prevention cohort.
Exclusion Criteria
Patients who meet the following exclusion criteria will be excluded from this study
- Patients with a diagnosis of valvular AF (standard disease code: 8846941), postoperative AF (8847772), AF associated with mechanical valve malfunction (T82.0), mechanical complication of heart valve prosthesis (T82.0), or rheumatic AF (I05-I09) during the baseline period.
- Patients with a diagnosis of venous thromboembolism (VTE) during the baseline period
- Patients who are prescribed any anticoagulants before index date.
- Patients who are prescribed anticoagulants other than warfarin and apixaban on the index date
- Patients who are continuously hospitalized due to the first incidence of stroke or other serious diseases.
Data sourced from ClinicalTrials.gov (NCT05321810). Outcome figures and adverse-event rates are extracted automatically from the registry's posted results and are provided for clinician reference, not as a substitute for the primary publication. Informational only — not medical advice.