NCT05321810

Safety and Effectiveness of Apixaban Compared to Warfarin in Secondary Prevention in Patients With Atrial Fibrillation

Completed Results posted Last updated 11 January 2024

What this trial tests

trial testing Apixaban in Non-valvular Atrial Fibrillation in 193,565 participants. Completed in 15 April 2022.

Timeline

15 April 2022

Primary endpoint
15 April 2022

15 April 2022

Quick facts

Lead sponsor	Pfizer
Status	Completed
Study type	OBSERVATIONAL
Enrollment	193,565
Start date	15 April 2022
Primary completion	15 April 2022
Estimated completion	15 April 2022
Sites	1 location across Japan

Drugs / interventions tested

• Apixaban (apixaban) — full drug profile →
• Warfarin (warfarin) — full drug profile →

Conditions studied

• Non-valvular Atrial Fibrillation — all drugs for Non-valvular Atrial Fibrillation →

Sponsor

Pfizer — full company profile →

Who can join

20 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.

Incidence Rate of a Composite of Recurrent Stroke or Systemic Embolism (SE) During the Follow-up Period: Secondary Prevention (Balanced) Cohort Primary · During follow up period (Data collected between 2008 to 2021 [approximately 13 years])

Incidence rate was reported as events per 1,000 participant-years. First occurrence of recurrent stroke or SE events after index date during the follow-up period were considered. Recurrent meant "once participants were discharged from the hospital and became outpatients and then rehospitalized due to stroke or SE". Index date was defined as the next day of the day when participants diagnosed with NVAF initiated warfarin or apixaban. The follow up period was the period until the first observation of the earlier of the following from index date: until discontinuation of index oral anticoagulants

Group	Value	95% CI
Secondary Prevention Cohort (Balanced): Apixaban	41.217	36.274 – 46.834
Secondary Prevention Cohort (Balanced): Warfarin	50.581	45.658 – 56.034

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 Primary · 0 month

In this outcome measure, probability of participants being event-free at 0 month was reported, which was estimated by using a Kaplan-Meier method. (Here, "event" meant recurrent stroke or systemic embolism). Recurrent meant "once participants were discharged from the hospital and became outpatients and then rehospitalized due to stroke or SE".

Group	Value	95% CI
Secondary Prevention Cohort (Balanced): Apixaban	1.000	1.000 – 1.000
Secondary Prevention Cohort (Balanced): Warfarin	1.000	1.000 – 1.000

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 Primary · 6 months

In this outcome measure, probability of participants being event-free at 6 months was reported, which was estimated by using a Kaplan-Meier method. (Here, "event" meant recurrent stroke or systemic embolism). Recurrent meant "once participants were discharged from the hospital and became outpatients and then rehospitalized due to stroke or SE".

Group	Value	95% CI
Secondary Prevention Cohort (Balanced): Apixaban	0.971	0.966 – 0.976
Secondary Prevention Cohort (Balanced): Warfarin	0.967	0.961 – 0.972

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 Primary · 12 months

In this outcome measure, probability of participants being event-free at 12 months was reported, which was estimated by using a Kaplan-Meier method. (Here, "event" meant recurrent stroke or systemic embolism). Recurrent meant "once participants were discharged from the hospital and became outpatients and then rehospitalized due to stroke or SE".

Group	Value	95% CI
Secondary Prevention Cohort (Balanced): Apixaban	0.953	0.946 – 0.960
Secondary Prevention Cohort (Balanced): Warfarin	0.948	0.938 – 0.956

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 Primary · 18 months

In this outcome measure, probability of participants being event-free at 18 months was reported, which was estimated by using a Kaplan-Meier method. (Here, "event" meant recurrent stroke or systemic embolism). Recurrent meant "once participants were discharged from the hospital and became outpatients and then rehospitalized due to stroke or SE".

Group	Value	95% CI
Secondary Prevention Cohort (Balanced): Apixaban	0.942	0.933 – 0.951
Secondary Prevention Cohort (Balanced): Warfarin	0.932	0.920 – 0.943

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 Primary · 24 months

In this outcome measure, probability of participants being event-free at 24 months was reported, which was estimated by using a Kaplan-Meier method. (Here, "event" meant recurrent stroke or systemic embolism). Recurrent meant "once participants were discharged from the hospital and became outpatients and then rehospitalized due to stroke or SE".

Group	Value	95% CI
Secondary Prevention Cohort (Balanced): Apixaban	0.933	0.921 – 0.942
Secondary Prevention Cohort (Balanced): Warfarin	0.915	0.900 – 0.928

Number of Participants With Risk of a Composite of Recurrent Stroke or SE at 0 Month: Secondary Prevention (Balanced) Cohorts Primary · 0 month

In this outcome measure, number of participants with risk of a composite of recurrent stroke (ischemic and hemorrhagic stroke)/SE at 0 month was reported. Recurrent meant "once participants were discharged from the hospital and became outpatients and then rehospitalized due to stroke or SE".

Group	Value	95% CI
Secondary Prevention Cohort (Balanced): Apixaban	7796
Secondary Prevention Cohort (Balanced): Warfarin	11601

Number of Participants With Risk of a Composite of Recurrent Stroke or SE at 6 Months: Secondary Prevention (Balanced) Cohorts Primary · 6 months

In this outcome measure, number of participants with risk of a composite of recurrent stroke (ischemic and hemorrhagic stroke)/SE at 6 months was reported. Recurrent meant "once participants were discharged from the hospital and became outpatients and then rehospitalized due to stroke or SE".

Group	Value	95% CI
Secondary Prevention Cohort (Balanced): Apixaban	2061
Secondary Prevention Cohort (Balanced): Warfarin	2393

Number of Participants With Risk of a Composite of Recurrent Stroke or SE at 12 Months: Secondary Prevention (Balanced) Cohorts Primary · 12 months

In this outcome measure, number of participants with risk of a composite of recurrent stroke (ischemic and hemorrhagic stroke)/SE at 12 months was reported. Recurrent meant "once participants were discharged from the hospital and became outpatients and then rehospitalized due to stroke or SE".

Group	Value	95% CI
Secondary Prevention Cohort (Balanced): Apixaban	1426
Secondary Prevention Cohort (Balanced): Warfarin	1670

Number of Participants With Risk of a Composite of Recurrent Stroke or SE at 18 Months: Secondary Prevention (Balanced) Cohorts Primary · 18 months

In this outcome measure, number of participants with risk of a composite of recurrent stroke (ischemic and hemorrhagic stroke)/SE at 18 months was reported. Recurrent meant "once participants were discharged from the hospital and became outpatients and then rehospitalized due to stroke or SE".

Group	Value	95% CI
Secondary Prevention Cohort (Balanced): Apixaban	1095
Secondary Prevention Cohort (Balanced): Warfarin	1272

Number of Participants With Risk of a Composite of Recurrent Stroke or SE at 24 Months: Secondary Prevention (Balanced) Cohorts Primary · 24 months

In this outcome measure, number of participants with risk of a composite of recurrent stroke (ischemic and hemorrhagic stroke)/SE at 24 months was reported. Recurrent meant "once participants were discharged from the hospital and became outpatients and then rehospitalized due to stroke or SE".

Group	Value	95% CI
Secondary Prevention Cohort (Balanced): Apixaban	845
Secondary Prevention Cohort (Balanced): Warfarin	1024

Incidence Rate of Major Bleeding During the Follow-up Period: Secondary Prevention (Balanced) Cohorts Primary · During follow up period (Data collected between 2008 to 2021 [approximately 13 years])

Incidence rate was reported as events per 1,000 participant-years. First occurrence of major bleeding after index date during the follow-up period was considered. Major bleeding, was defined as any bleeding which required hospitalization for treatment (the primary reason for the hospitalization was to treat the bleeding). Index date was defined as the next day of the day when participants diagnosed with NVAF initiated warfarin or apixaban. The follow up period was the period until the first observation of the earlier of the following from index date: until discontinuation of index OAC, switch

Group	Value	95% CI
Secondary Prevention Cohort (Balanced): Apixaban	28.351	24.318 – 33.054
Secondary Prevention Cohort (Balanced): Warfarin	39.083	34.793 – 43.903

Sponsor's own description

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).

Publications & conference data

No peer-reviewed publications indexed yet for this trial. Completed trials usually publish results within 12-18 months.