Non-valvular Atrial FibrillationNCT05471505

Safety and Effectiveness of Apixaban Compared to Warfarin in Patients With Non-valvular Atrial Fibrillation (a Type of Irregular Heart Rhythm) at Higher Chance of Bleeding

An observational study of Non-valvular Atrial Fibrillation, run by Pfizer at 1 site in Japan.

Completed

Finished. The study has ended and is not enrolling. Results may be posted on the official record.

Trial summary

The purpose of this study is to compare effectiveness and safety of warfarin and apixaban among non-valvular atrial fibrillation (NVAF) patients at higher chance of bleeding using a Japanese nation-wide administrative claims database. Read more about this study

Who is it for?: Ages 18 years and older
Conditions the study is for: Non-valvular Atrial Fibrillation
How many people: 120,722 participants
Where: 1 siteJapan
Study dates: 25 Aug 2022to 27 Sep 2022
Phase: Observational
Are there results?: Yes, posted in the registrySummary in the doctors' view

Key requirements

Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.

Ages 18 years and older
All sexes
No healthy volunteers
Adult, Older adult

Study population: This study uses data from the MDV database, which includes the data used for both inpatient and outpatient insurance claims by hospitals according to the Diagnosis Procedure Combination (DPC) procedure. The study population will consist of adults with NVAF who are newly prescribed apixaban or warfarin.

Who may be able to join

Diagnosed with atrial fibrillation (AF) anytime in the baseline period or on the index date, also have definitive diagnosis of AF anytime in the baseline period, on the index date, or post-index period.
Prescribed apixaban or warfarin on or after the day of AF diagnosis. The first observed prescription will be used to identify the patient's index date and treatment cohort
No use of the any oral anticoagulants (OACs) during the baseline period (the 180 days before the index date)
Age of 18 years or older on the index date

Who cannot join

Having a diagnosis of valvular atrial fibrillation, post-operative atrial fibrillation, rheumatic atrial fibrillation or mechanical-valvular atrial fibrillation during the baseline and post-index period
Having a procedure of prosthetic heart valve during the baseline period
Having a cardiac surgery procedure record during the baseline period
Having a diagnosis of venous thromboembolism during the baseline period
Having a hemodialysis during the baseline period
Female patients with pregnancy during the baseline and follow-up period
Patients prescribed apixaban other than approved daily dose (<5 mg or >10 mg)
Patients prescribed OACs during baseline period

Trial locations and contacts

1 site in 1 country.

Japan1 site

Pfizer
Tokyo

Other trials in Japan

About this study

Official title: Safety and Effectiveness of Apixaban Compared to Warfarin in NVAF Patients at Higher Risk of Bleeding.

The purpose of this study is to compare effectiveness and safety of warfarin and apixaban among non-valvular atrial fibrillation (NVAF) patients at higher chance of bleeding using a Japanese nation-wide administrative claims database.
Atrial fibrillation (AF) is characterized by a fast, irregular heartbeat which can cause blood to pool in the atria and increase the chance of the formation of blood clots.
An anticoagulation therapy is a critical treatment to prevent thromboembolism in NVAF patients.
Apixaban was demonstrated superiority compared to warfarin in preventing stroke or systemic embolism, caused less bleeding, and resulted in lower mortality in patients with AF in Phase 3 clinical trial.
Previously we have shown that bleeding risks as well as stroke/SE risks are less in real world clinical practice in Japan compared to warfarin. However there are limited apixaban data for Japanese NVAF patients with high bleeding risk(s).
This study will evaluate the risk of stroke/systemic embolism as well as the risk of bleeding in the real world settings in Japanese patients with NVAF who has higher chance of bleeding

Conditions: Non-valvular Atrial Fibrillation

What is being measured

The primary outcome is the main question the study is designed to answer.

Incidence Rate Per 1000 Participant-Years For First Occurrence of Composite Stroke and Systemic Embolism (SE) Events After Index Date: Balanced Cohorts
Incidence rate per 1000 participant-years for the first occurrence of composite stroke and SE events after index date was reported. Stroke events included the composite of any ischemic and any hemorrhagic stroke events (excluding non-traumatic extradural hemorrhage). Stroke after index date not including the index date was identified using hospital claims which had a stroke diagnosis code as the first listed International Classification of Diseases 10th Revision (ICD-10) diagnosis code. SE after index date not including the index date was identified using hospital claims which had a SE diagnosis code as the first listed ICD-10 diagnosis code. Index date: date when participants initiated warfarin or apixaban. Follow-up period: from next day of the index date till occurrence of target outcome event, discontinuation of apixaban or warfarin; switching from apixaban or warfarin; withdrawal from the database, whichever occurred first.
Measured: Follow-up period during data observation period from Mar 2011 to Jun 2021 (approximately 10 years 4 months); extracted data evaluated in approximately 1 month of this study
Incidence Rate Per 1000 Participant-Years For First Occurrence of Major Bleeding Event After Index Date: Balanced Cohorts
Incidence rate per 1000 participant-years for the first occurrence of major bleeding event after index date was reported. Major bleeding was defined as any bleeding that required hospitalization for treatment. Major bleeding after index date was identified using hospital claims which had a bleeding diagnosis code as the first listed ICD-10 or disease code. Index date: date when participants initiated warfarin or apixaban. Follow-up period: from next day of the index date till occurrence of target outcome event, discontinuation of apixaban or warfarin; switching from apixaban or warfarin; withdrawal from the database, whichever occurred first.
Measured: Follow-up period during data observation period from Mar 2011 to Jun 2021 (approximately 10 years 4 months); extracted data evaluated in approximately 1 month of this study

Secondary outcomes (5)

Incidence Rate Per 1000 Participant-Years For First Occurrence of Ischemic Stroke Event After Index Date: Balanced Cohorts
Incidence rate per 1000 participant-years for the first occurrence of ischemic stroke event after index date was reported. Ischemic stroke after index date not including the index date was identified using hospital claims which had an ischemic stroke diagnosis code as the first listed ICD-10 diagnosis code. Index date: date when participants initiated warfarin or apixaban. Follow-up period: from next day of the index date till occurrence of target outcome event, discontinuation of apixaban or warfarin; switching from apixaban or warfarin; withdrawal from the database, whichever occurred first.
Measured: Follow-up period during data observation period from Mar 2011 to Jun 2021 (approximately 10 years 4 months); extracted data evaluated in approximately 1 month of this study
Incidence Rate Per 1000 Participant-Years For First Occurrence of Hemorrhagic Stroke Event After Index Date: Balanced Cohorts
Incidence rate per 1000 participant-years for the first occurrence of hemorrhagic stroke event after index date was reported. Hemorrhagic stroke after index date not including the index date was identified using hospital claims which had a hemorrhagic stroke diagnosis code as the first listed ICD-10 diagnosis code. Index date: date when participants initiated warfarin or apixaban. Follow-up period: from next day of the index date till occurrence of target outcome event, discontinuation of apixaban or warfarin; switching from apixaban or warfarin; withdrawal from the database, whichever occurred first.
Measured: Follow-up period during data observation period from Mar 2011 to Jun 2021 (approximately 10 years 4 months); extracted data evaluated in approximately 1 month of this study
Incidence Rate Per 1000 Participant-Years For First Occurrence of Systemic Embolism (SE) Event After Index Date: Balanced Cohorts
Incidence rate per 1000 participant-years for the first occurrence of SE event after index date was reported. SE after index date not including the index date was identified using hospital claims which had a SE diagnosis code as the first listed ICD-10 diagnosis code. Index date: date when participants initiated warfarin or apixaban. Follow-up period: from next day of the index date till occurrence of target outcome event, discontinuation of apixaban or warfarin; switching from apixaban or warfarin; withdrawal from the database, whichever occurred first.
Measured: Follow-up period during data observation period from Mar 2011 to Jun 2021 (approximately 10 years 4 months); extracted data evaluated in approximately 1 month of this study
Incidence Rate Per 1000 Participant-Years For First Occurrence of Major Intracranial Bleeding Event After Index Date: Balanced Cohorts
Incidence rate per 1000 participant-years for the first occurrence of major intracranial bleeding event after index date was reported. Major intracranial bleeding after index date was identified using hospital claims which had an intracranial bleeding diagnosis code as the first listed ICD-10 or disease code. Index date: date when participants initiated warfarin or apixaban. Follow-up period: from next day of the index date till occurrence of target outcome event, discontinuation of apixaban or warfarin; switching from apixaban or warfarin; withdrawal from the database, whichever occurred first.
Measured: Follow-up period during data observation period from Mar 2011 to Jun 2021 (approximately 10 years 4 months); extracted data evaluated in approximately 1 month of this study
Incidence Rate Per 1000 Participant-Years For First Occurrence of Major Gastrointestinal (GI) Bleeding Event After Index Date: Balanced Cohorts
Incidence rate per 1000 participant-years for the first occurrence of major GI bleeding event after index date was reported. Any GI bleeding after index date was identified using hospital claims which had a GI bleeding diagnosis code as the first listed ICD-10 or disease code. Index date: date when participants initiated warfarin or apixaban. Follow-up period: from next day of the index date till occurrence of target outcome event, discontinuation of apixaban or warfarin; switching from apixaban or warfarin; withdrawal from the database, whichever occurred first.
Measured: Follow-up period during data observation period from Mar 2011 to Jun 2021 (approximately 10 years 4 months); extracted data evaluated in approximately 1 month of this study

Timeline

From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.

25 Aug 202227 Sep 2022

First posted22 Jul 2022
Study start25 Aug 2022
Primary completion27 Sep 2022
Study completion27 Sep 2022

Resources

Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
Posted resultsParticipant flow, outcome measures and adverse events reported by the sponsor.
Other trials for Non-valvular Atrial FibrillationStudies of the same condition, open and under way.
More trials run by PfizerThe sponsor's other registered studies.
What the trial phases meanHow a treatment moves from first tests in people to approval.

More details

For doctors and researchers: how the study is designed, who runs it, and its registry IDs.

Study design

Study type: Observational
Observational model: Other
Time perspective: Retrospective
Enrolment: 120,722 participants (actual)

IDs, dates and publications

ClinicalTrials.gov ID: NCT05471505
Sponsor's protocol ID: B0661178
Status last verified: Jun 2024
First submitted: 28 Jun 2022
Last updated: 11 Jul 2024
Results posted: Yes, on ClinicalTrials.gov
Individual data sharing: No: Pfizer will provide access to individual de-identified participant data and related study documents (e.g. protocol, Statistical Analysis Plan (SAP), Clinical Study Report (CSR)) upon request from qualified researchers, and subject to certain criteria, conditions, and exceptions. Further details on Pfizer's data sharing criteria and process for requesting access can be found at: https://www.pfizer.com/science/clinical\_trials/trial\_data\_and\_results/data\_requests.

Want to know more?

The sponsor has not listed a contact. The official record may have more details.

Talk to your doctor first and take this page with you. Only the study team can confirm whether you can join.

Questions to ask the study team

What is the study trying to find out?
What would I need to do, and how often would I visit?
Could I receive a placebo instead of the treatment?
What are the possible risks and benefits for me?
Will it cost me anything? Are travel or time paid for?
Can I keep seeing my own doctor during the study?
What happens when the study ends?

See locations

Active, not recruiting
An Early Feasibility Study Evaluating the Safety and Efficacy of the Laminar Left Atrial Appendage Closure System in Subjects With Non-Valvular Atrial Fibrillation
Non-valvular Atrial Fibrillation
Active, not recruiting
CHAMPION-AF Clinical Trial
Atrial Fibrillation, Stroke
Not yet recruitingPhase 2
Vortosiran in Atrial Fibrillation
Non-valvular Atrial Fibrillation (AF)
Active, not recruitingObservational study
WATCHMAN FLX Pro European Registry
Non-valvular Atrial Fibrillation (AF), Left Atrial Appendage Closure
Active, not recruiting
LAmbre™ II Left Atrial Appendage Occluder and Occluder Delivery System for Patients With Non-Valvular Atrial Fibrillation
Non Valvular Atrial Fibrillation

All Non-valvular Atrial Fibrillation trials

Study at a glance

From the registry record, last updated by the sponsor on 11 Jul 2024. Recruitment status is as the sponsor reported it: confirm with the study team.

Official title: Safety and Effectiveness of Apixaban Compared to Warfarin in NVAF Patients at Higher Risk of Bleeding.
ClinicalTrials.gov ID: NCT05471505
Acronym / sponsor ID: B0661178
Conditions: Non-valvular Atrial Fibrillation
Study type: Observational
Recruitment status: Completed
Enrolment: 120,722 participants (actual)
Lead sponsor: PfizerIndustry (pharma, biotech, devices)
Study start: 25 Aug 2022 (actual)
Primary completion: 27 Sep 2022 (actual)
Study completion: 27 Sep 2022 (actual)
First posted: 22 Jul 2022 (actual)
Results: Posted 11 Jul 2024

Clinical summary

The research question as the sponsor registered it. This describes what the study plans to test, not what it found.

The purpose of this study is to compare effectiveness and safety of warfarin and apixaban among non-valvular atrial fibrillation (NVAF) patients at higher chance of bleeding using a Japanese nation-wide administrative claims database.
Atrial fibrillation (AF) is characterized by a fast, irregular heartbeat which can cause blood to pool in the atria and increase the chance of the formation of blood clots.
An anticoagulation therapy is a critical treatment to prevent thromboembolism in NVAF patients.
Apixaban was demonstrated superiority compared to warfarin in preventing stroke or systemic embolism, caused less bleeding, and resulted in lower mortality in patients with AF in Phase 3 clinical trial.
Previously we have shown that bleeding risks as well as stroke/SE risks are less in real world clinical practice in Japan compared to warfarin. However there are limited apixaban data for Japanese NVAF patients with high bleeding risk(s).
This study will evaluate the risk of stroke/systemic embolism as well as the risk of bleeding in the real world settings in Japanese patients with NVAF who has higher chance of bleeding

Study design

Observational model: Other
Time perspective: Retrospective

Who may qualify

Ages: 18 years and older
Sex: All
Healthy volunteers: Not accepted
Age groups: Adult, Older adult
Study population: This study uses data from the MDV database, which includes the data used for both inpatient and outpatient insurance claims by hospitals according to the Diagnosis Procedure Combination (DPC) procedure. The study population will consist of adults with NVAF who are newly prescribed apixaban or warfarin.

Key inclusion criteria (4 listed)

Diagnosed with atrial fibrillation (AF) anytime in the baseline period or on the index date, also have definitive diagnosis of AF anytime in the baseline period, on the index date, or post-index period.
Prescribed apixaban or warfarin on or after the day of AF diagnosis. The first observed prescription will be used to identify the patient's index date and treatment cohort
No use of the any oral anticoagulants (OACs) during the baseline period (the 180 days before the index date)
Age of 18 years or older on the index date

Key exclusion criteria (8 listed)

Having a diagnosis of valvular atrial fibrillation, post-operative atrial fibrillation, rheumatic atrial fibrillation or mechanical-valvular atrial fibrillation during the baseline and post-index period
Having a procedure of prosthetic heart valve during the baseline period
Having a cardiac surgery procedure record during the baseline period
Having a diagnosis of venous thromboembolism during the baseline period
Having a hemodialysis during the baseline period

Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.

Primary outcome

Incidence Rate Per 1000 Participant-Years For First Occurrence of Composite Stroke and Systemic Embolism (SE) Events After Index Date: Balanced Cohorts
Time frame: Follow-up period during data observation period from Mar 2011 to Jun 2021 (approximately 10 years 4 months); extracted data evaluated in approximately 1 month of this study
Incidence rate per 1000 participant-years for the first occurrence of composite stroke and SE events after index date was reported. Stroke events included the composite of any ischemic and any hemorrhagic stroke events (excluding non-traumatic extradural hemorrhage). Stroke after index date not including the index date was identified using hospital claims which had a stroke diagnosis code as the first listed International Classification of Diseases 10th Revision (ICD-10) diagnosis code. SE after index date not including the index date was identified using hospital claims which had a SE diagnosis code as the first listed ICD-10 diagnosis code. Index date: date when participants initiated warfarin or apixaban. Follow-up period: from next day of the index date till occurrence of target outcome event, discontinuation of apixaban or warfarin; switching from apixaban or warfarin; withdrawal from the database, whichever occurred first.
Incidence Rate Per 1000 Participant-Years For First Occurrence of Major Bleeding Event After Index Date: Balanced Cohorts
Time frame: Follow-up period during data observation period from Mar 2011 to Jun 2021 (approximately 10 years 4 months); extracted data evaluated in approximately 1 month of this study
Incidence rate per 1000 participant-years for the first occurrence of major bleeding event after index date was reported. Major bleeding was defined as any bleeding that required hospitalization for treatment. Major bleeding after index date was identified using hospital claims which had a bleeding diagnosis code as the first listed ICD-10 or disease code. Index date: date when participants initiated warfarin or apixaban. Follow-up period: from next day of the index date till occurrence of target outcome event, discontinuation of apixaban or warfarin; switching from apixaban or warfarin; withdrawal from the database, whichever occurred first.

5 secondary outcomes

Incidence Rate Per 1000 Participant-Years For First Occurrence of Ischemic Stroke Event After Index Date: Balanced Cohorts
Time frame: Follow-up period during data observation period from Mar 2011 to Jun 2021 (approximately 10 years 4 months); extracted data evaluated in approximately 1 month of this study
Incidence Rate Per 1000 Participant-Years For First Occurrence of Hemorrhagic Stroke Event After Index Date: Balanced Cohorts
Time frame: Follow-up period during data observation period from Mar 2011 to Jun 2021 (approximately 10 years 4 months); extracted data evaluated in approximately 1 month of this study
Incidence Rate Per 1000 Participant-Years For First Occurrence of Systemic Embolism (SE) Event After Index Date: Balanced Cohorts
Time frame: Follow-up period during data observation period from Mar 2011 to Jun 2021 (approximately 10 years 4 months); extracted data evaluated in approximately 1 month of this study
Incidence Rate Per 1000 Participant-Years For First Occurrence of Major Intracranial Bleeding Event After Index Date: Balanced Cohorts
Time frame: Follow-up period during data observation period from Mar 2011 to Jun 2021 (approximately 10 years 4 months); extracted data evaluated in approximately 1 month of this study
Incidence Rate Per 1000 Participant-Years For First Occurrence of Major Gastrointestinal (GI) Bleeding Event After Index Date: Balanced Cohorts
Time frame: Follow-up period during data observation period from Mar 2011 to Jun 2021 (approximately 10 years 4 months); extracted data evaluated in approximately 1 month of this study

Results and safety

Results posted to the registry on 11 Jul 2024, as reported by the sponsor. Figures are copied from the record, not re-analysed. Full results on ClinicalTrials.gov.

Participant flow

Group	Started	Completed
Apixaban	72,095	72,095
Warfarin	48,627	48,627

Primary outcome: Incidence Rate Per 1000 Participant-Years For First Occurrence of Composite Stroke and Systemic Embolism (SE) Events After Index Date: Balanced Cohorts

Time frame: Follow-up period during data observation period from Mar 2011 to Jun 2021 (approximately 10 years 4 months); extracted data evaluated in approximately 1 month of this study. Number (95% Confidence Interval). Unit: Events Per 1000 Participant-Years

Measure	Apixaban: Balanced Cohort n = 72141	Warfarin: Balanced Cohort n = 48619
Value	61.352 (59.413 to 63.354)	75.078 (72.748 to 77.483)

Apixaban: Balanced Cohort vs Warfarin: Balanced Cohort: Hazard Ratio (HR): 0.752 (95% CI 0.719 to 0.787), p <0.001, COX Proportional Hazards Regression

Population analysed: Eligible participants registered on MDV database, whose data was observed in the study. Analysis performed using Inverse probability treatment weighting (IPTW) method to balance participant characteristics among reporting groups. Here, "Overall Number of Participants Analyzed" is the number of participants after application of IPTW method to raw numbers and is different from the actual participants included in the reporting arm.

Primary outcome: Incidence Rate Per 1000 Participant-Years For First Occurrence of Major Bleeding Event After Index Date: Balanced Cohorts

Measure	Apixaban: Balanced Cohort n = 72141	Warfarin: Balanced Cohort n = 48619
Value	16.788 (15.808 to 17.829)	21.329 (20.138 to 22.590)

Apixaban: Balanced Cohort vs Warfarin: Balanced Cohort: Hazard Ratio (HR): 0.747 (95% CI 0.687 to 0.813), p <0.001, COX Proportional Hazards Regression

Population analysed: Eligible participants registered on MDV database, whose data was observed in the study. Analysis performed using IPTW method to balance participant characteristics among reporting groups. Here, "Overall Number of Participants Analyzed" is the number of participants after application of IPTW method to raw numbers and is different from the actual participants included in the reporting arm.

5 secondary outcomes are reported in the full results.

Adverse events

Time frame: Not applicable as safety data was not planned to be collected during the study. Other adverse events reported at 0% frequency or more

Group	Serious adverse events	Other adverse events	Deaths
Apixaban	0 of 0	0 of 0	0
Warfarin	0 of 0	0 of 0	0

Loading the posted results from ClinicalTrials.gov…

Research links

Official record on ClinicalTrials.govLast updated by the sponsor 11 Jul 2024.
Posted resultsParticipant flow, baseline, all outcome measures and adverse events.
To obtain contact information for a study center near you, click here.Link provided by the sponsor.
Individual participant dataSharing planned: No. Pfizer will provide access to individual de-identified participant data and related study documents (e.g. protocol, Statistical Analysis Plan (SAP), Clinical Study Report (CSR)) upon request from qualified researchers, and subject to certain criteria, conditions, and exceptions. Further details on Pfizer's data sharing criteria and process for requesting access can be found at: https://www.pfizer.com/science/clinical_trials/trial_data_and_results/data_requests.

Related trials for Non-valvular Atrial Fibrillation

Active, not recruiting
An Early Feasibility Study Evaluating the Safety and Efficacy of the Laminar Left Atrial Appendage Closure System in Subjects With Non-Valvular Atrial Fibrillation
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Active, not recruiting
CHAMPION-AF Clinical Trial
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LAmbre™ II Left Atrial Appendage Occluder and Occluder Delivery System for Patients With Non-Valvular Atrial Fibrillation
Non Valvular Atrial Fibrillation

Referral and contact

AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.

Pfizer CT.gov Call Center study director

Pfizer

1 site in 1 country: see every site and its status.

Questions about this trial

What is this clinical trial studying?

An observational study of Non-valvular Atrial Fibrillation, run by Pfizer at 1 site in Japan.

The full registered description is in the About this study section and the official record.

Who may be eligible to take part?

The sponsor lists 4 inclusion and 8 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.

Is this clinical trial currently recruiting?

The record says: finished, as of the sponsor's last update on 11 Jul 2024. Status can change between updates, so confirm with the study contact before making plans.

Where is the study taking place?

The record lists 1 site in Japan. Whether a site is taking part right now should be confirmed with that site. See every site.

What are the possible benefits and risks?

They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.

Are results available for this study?

Yes. Results are posted in the registry (first posted 11 Jul 2024). A summary is in the For doctors view, and the full results are on ClinicalTrials.gov.

How can a doctor refer a patient or contact the research team?

The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.

What does the primary outcome measure?

Incidence Rate Per 1000 Participant-Years For First Occurrence of Composite Stroke and Systemic Embolism (SE) Events After Index Date: Balanced Cohorts (time frame: Follow-up period during data observation period from Mar 2011 to Jun 2021 (approximately 10 years 4 months); extracted data evaluated in approximately 1 month of this study). The study lists 2 primary outcomes in all. It is what the study was designed to measure, not a finding.

Where can I read the original study information?

On the ClinicalTrials.gov record for NCT05471505.

Does a listing mean the treatment is approved or proven to work?

No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.

How often is this information updated?

AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 11 Jul 2024.