Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
The objective of this study is to investigate safety and effectiveness of apixaban compared to warfarin in very elderly patients with Non-valvular atrial fibrillation (NVAF). In addition to the absolute age, effects on higher age-related risk factors on relative risk of apixaban to warfarin is also investigated through subgroup analyses.
This is a retrospective non-intervention observational study to evaluate the difference in safety and effectiveness between apixaban and warfarin using a database provided by Medical Data Vision Co. Ltd. (MDV Co. Ltd.). Eligible patients will be extracted from the database and allocated to the pre-defined cohorts based on the actual age, age of NVAF diagnosis and types of anticoagulant therapy.
Patient characteristics will be balanced by an Inverse probability of treatment weighting (IPTW) method, and risk of stroke/SE (primary effectiveness endpoint) and major bleeding (primary safety endpoint) will be compared.
Not provided
Not provided
Not provided
Not provided
Not provided
| Label | Type | Description | Intervention Names |
|---|---|---|---|
| Warfarin cohort (Reference) | Patients with NVAF treated with warfarin |
| |
| Apixaban cohort | Patients with NVAF treated with apixaban |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| Warfarin | Drug | This is observational study and the patients in the warfarin cohort include those who are exposed to warfarin in the real world settings. |
|
| Measure | Description | Time Frame |
|---|---|---|
| Incidence Rate (Per 1,000 Participant-Year) of Composite of Stroke and Systemic Embolism (SE): 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 ischemic and hemorrhagic stroke. International Classification of Diseases 10th Revision (ICD-10) diagnosis code was used to label the events. Index date was defined as a date when participants initiated warfarin or apixaban. Follow-up period: the next day of the index date till occurrence of target outcome, discontinuation of the warfarin or apixaban, switching from the warfarin or apixaban, withdrawal from the database, whichever observed first. | Follow-up period during data observation period from 26-Feb-2013 to 31-Dec-2021 (approximately 8 years 10 months); extracted data evaluated in approximately 3.5 months of this study |
| Incidence Rate (Per 1,000 Participant-Year) of Major Bleeding: 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. ICD-10 diagnosis code was used to label the events. Index date was defined as a date when participants initiated warfarin or apixaban. Follow-up period: the next day of the index date till occurrence of target outcome, discontinuation of the warfarin or apixaban, switching from the warfarin or apixaban, withdrawal from the database, whichever observed first. | Follow-up period during data observation period from 26-Feb-2013 to 31-Dec-2021 (approximately 8 years 10 months); extracted data evaluated in approximately 3.5 months of this study |
| Measure | Description | Time Frame |
|---|---|---|
| Incidence Rate (Per 1,000 Participant-Year) of Cardiogenic Cerebral Embolism: Balanced Cohorts | Incidence rate per 1000 participant-years for the first occurrence of cardiogenic cerebral embolism events after index date was reported. ICD-10 diagnosis code was used to label the events. Index date was defined as a date when participants initiated warfarin or apixaban. Follow-up period: the next day of the index date till occurrence of target outcome, discontinuation of the warfarin or apixaban, switching from warfarin or apixaban, withdrawal from the database, whichever observed first. |
Not provided
Inclusion Criteria:
Patients must meet all the following inclusion criteria to be eligible for inclusion in the study.
Exclusion Criteria:
Patients meeting any of the following criteria will not be included in the study:
Not provided
Not provided
Not provided
Patients aged 80 years or older who are newly diagnosed with non-valvular atrial fibrillation (NVAF) and initiate anticoagulation therapy with warfarin or apixaban.
Not provided
| Name | Affiliation | Role |
|---|---|---|
| Pfizer CT.gov Call Center | Pfizer | Study Director |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| Pfizer Site | Tokyo | Japan |
| PubMed Identifier | Type | Citation | Retractions |
|---|---|---|---|
| 40627071 | Derived | Matsuo-Ohsawa A, Katada J, Kohsaka S. Safety and Effectiveness of Apixaban in Very Elderly Patients with Atrial Fibrillation: A Retrospective Analysis of Japanese Administrative Claims Data. Cardiol Ther. 2025 Dec;14(4):565-581. doi: 10.1007/s40119-025-00420-w. Epub 2025 Jul 8. |
| Label | URL |
|---|---|
| To obtain contact information for a study center near you, click here. | View source |
Not provided
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.
Not provided
Not provided
Not provided
Not provided
Data of eligible participants were extracted from Medical Data Vision Company Limited (MDV Co. Ltd.) database for duration of 26-Feb-2013 to 31-Dec-2021. Extracted data was evaluated for objectives of this study in approximately 3.5 months of this study.
Data of participants who received apixaban or warfarin (80 years or older) after getting diagnosed with non-valvular atrial fibrillation (NVAF) were observed in this retrospective observational study.
Not provided
| ID | Title | Description |
|---|---|---|
| FG000 | Warfarin Cohort | Participants included in this cohort were those who received warfarin in real world practice after getting diagnosed with NVAF. Data of the participants included were retrieved from MDV database and was observed retrospectively in this study. |
| FG001 | Apixaban Cohort |
| Title | Milestones | Reasons Not Completed | |||||
|---|---|---|---|---|---|---|---|
| Overall Study |
|
Not provided
Not provided
| Type | Includes Protocol | Includes SAP | Includes ICF | Document Label | Document Date | Document Uploaded Date | Document File Name |
|---|---|---|---|---|---|---|---|
| Prot | Yes | No | No | Study Protocol | Aug 10, 2023 | Oct 2, 2023 |
Not provided
Not provided
Not provided
Not provided
| Apixaban | Drug | This is observational study and the patients in the apixaban cohort include those who are exposed to apixaban in the real world settings. |
|
| Follow-up period during data observation period from 26-Feb-2013 to 31-Dec-2021 (approximately 8 years 10 months); extracted data evaluated in approximately 3.5 months of this study |
| Incidence Rate (Per 1,000 Participant-Year) of Ischemic Stroke (Cerebral Infarction): Balanced Cohorts | Incidence rate per 1000 participant-years for the first occurrence of ischemic stroke event after index date was reported. ICD-10 diagnosis code was used to label the events. Index date was defined as a date when participants initiated warfarin or apixaban. Follow-up period: the next day of the index date till occurrence of target outcome, discontinuation of the warfarin or apixaban, switching from warfarin or apixaban, withdrawal from the database, whichever observed first. | Follow-up period during data observation period from 26-Feb-2013 to 31-Dec-2021 (approximately 8 years 10 months); extracted data evaluated in approximately 3.5 months of this study |
| Incidence Rate (Per 1,000 Participant-Year) of Intracranial Hemorrhage: Balanced Cohorts | Incidence rate per 1000 participant-years for the first occurrence of intracranial hemorrhage event after index date was reported. ICD-10 diagnosis code was used to label the events. Index date was defined as a date when participants initiated warfarin or apixaban. Follow-up period: the next day of the index date till occurrence of target outcome, discontinuation of the warfarin or apixaban, switching from warfarin or apixaban, withdrawal from the database, whichever observed first. | Follow-up period during data observation period from 26-Feb-2013 to 31-Dec-2021 (approximately 8 years 10 months); extracted data evaluated in approximately 3.5 months of this study |
| Incidence Rate (Per 1,000 Participant-Year) of Gastrointestinal Bleeding: Balanced Cohorts | Incidence rate per 1000 participant-years for the first occurrence of major GI bleeding event after index date was reported. ICD-10 diagnosis code was used to label the events. Index date was defined as a date when participants initiated warfarin or apixaban. Follow-up period: the next day of the index date till occurrence of target outcome, discontinuation of the warfarin or apixaban, switching from warfarin or apixaban, withdrawal from the database, whichever observed first. | Follow-up period during data observation period from 26-Feb-2013 to 31-Dec-2021 (approximately 8 years 10 months); extracted data evaluated in approximately 3.5 months of this study |
| Incidence Rate (Per 1,000 Participant-Year) of Intraocular Bleeding: Balanced Cohorts | Incidence rate per 1000 participant-years for the first occurrence of intraocular bleeding event after index date was reported. ICD-10 diagnosis code was used to label the events. Index date was defined as a date when participants initiated warfarin or apixaban. Follow-up period: the next day of the index date till occurrence of target outcome, discontinuation of the warfarin or apixaban, switching from warfarin or apixaban, withdrawal from the database, whichever observed first. | Follow-up period during data observation period from 26-Feb-2013 to 31-Dec-2021 (approximately 8 years 10 months); extracted data evaluated in approximately 3.5 months of this study |
Participants included in this cohort were those who received apixaban in real world practice after getting diagnosed with NVAF. Data of the participants included were retrieved from MDV database and was observed retrospectively in this study. |
| COMPLETED |
|
| NOT COMPLETED |
|
All eligible participants whose data were extracted from database and observed in the study.
Not provided
| ID | Title | Description |
|---|---|---|
| BG000 | Warfarin Cohort | Participants included in this cohort were those who received warfarin in real world practice after getting diagnosed with NVAF. Data of the participants included were retrieved from MDV database and was observed retrospectively in this study. |
| BG001 | Apixaban Cohort | Participants included in this cohort were those who received apixaban in real world practice after getting diagnosed with NVAF. Data of the participants included were retrieved from MDV database and was observed retrospectively in this study. |
| BG002 | Total | Total of all reporting groups |
| Units | Counts |
|---|---|
| Participants |
|
| Title | Description | Population Description | Parameter Type | Dispersion Type | Unit of Measure | Calculate Percentage | Denominator Units Selected | Denominators | Classes | ||||||||||
|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|
| Age, Continuous | Mean | Standard Deviation | Years |
| |||||||||||||||
| Sex: Female, Male | Count of Participants | Participants |
| ||||||||||||||||
| Race and Ethnicity Not Collected | Race and Ethnicity were not collected from any participant. | Count of Participants | Participants |
|
| Type | Title | Description | Population Description | Reporting Status | Anticipated Posting Date | Parameter Type | Dispersion Type | Unit of Measure | Calculate Percentage | Time Frame | Units Analyzed | Denominator Units Selected | Arm/Group Information | Denominators | Classes | Analyses | |||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||
|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|
| Primary | Incidence Rate (Per 1,000 Participant-Year) of Composite of Stroke and Systemic Embolism (SE): 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 ischemic and hemorrhagic stroke. International Classification of Diseases 10th Revision (ICD-10) diagnosis code was used to label the events. Index date was defined as a date when participants initiated warfarin or apixaban. Follow-up period: the next day of the index date till occurrence of target outcome, discontinuation of the warfarin or apixaban, switching from the warfarin or apixaban, withdrawal from the database, whichever observed first. | Eligible participants registered on MDV database, whose data was observed in the study. Analysis was performed using inverse probability treatment weighting with stabilized weights (s-IPTW) method to balance participant characteristics among reporting groups. Here, "Overall Number of Participants Analyzed" is the number of participants after application of s-IPTW method to raw numbers and is different from the actual participants included in the reporting arm. | Posted | Number | 95% Confidence Interval | Events Per 1000 Participant-Years | Follow-up period during data observation period from 26-Feb-2013 to 31-Dec-2021 (approximately 8 years 10 months); extracted data evaluated in approximately 3.5 months of this study |
|
|
|
| |||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||
| Primary | Incidence Rate (Per 1,000 Participant-Year) of Major Bleeding: 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. ICD-10 diagnosis code was used to label the events. Index date was defined as a date when participants initiated warfarin or apixaban. Follow-up period: the next day of the index date till occurrence of target outcome, discontinuation of the warfarin or apixaban, switching from the warfarin or apixaban, withdrawal from the database, whichever observed first. | Eligible participants registered on MDV database, whose data was observed in the study. Analysis was performed using s-IPTW method to balance participant characteristics among reporting groups. Here, "Overall Number of Participants Analyzed" is the number of participants after application of s-IPTW method to raw numbers and is different from the actual participants included in the reporting arm. | Posted | Number | 95% Confidence Interval | Events Per 1000 Participant-Years | Follow-up period during data observation period from 26-Feb-2013 to 31-Dec-2021 (approximately 8 years 10 months); extracted data evaluated in approximately 3.5 months of this study |
| ||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||
| Secondary | Incidence Rate (Per 1,000 Participant-Year) of Cardiogenic Cerebral Embolism: Balanced Cohorts | Incidence rate per 1000 participant-years for the first occurrence of cardiogenic cerebral embolism events after index date was reported. ICD-10 diagnosis code was used to label the events. Index date was defined as a date when participants initiated warfarin or apixaban. Follow-up period: the next day of the index date till occurrence of target outcome, discontinuation of the warfarin or apixaban, switching from warfarin or apixaban, withdrawal from the database, whichever observed first. | Eligible participants registered on MDV database, whose data was observed in the study. Analysis was performed using s-IPTW method to balance participant characteristics among reporting groups. Here, "Overall Number of Participants Analyzed" is the number of participants after application of s-IPTW method to raw numbers and is different from the actual participants included in the reporting arm. | Posted | Number | 95% Confidence Interval | Events Per 1000 Participant-Years | Follow-up period during data observation period from 26-Feb-2013 to 31-Dec-2021 (approximately 8 years 10 months); extracted data evaluated in approximately 3.5 months of this study |
| ||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||
| Secondary | Incidence Rate (Per 1,000 Participant-Year) of Ischemic Stroke (Cerebral Infarction): Balanced Cohorts | Incidence rate per 1000 participant-years for the first occurrence of ischemic stroke event after index date was reported. ICD-10 diagnosis code was used to label the events. Index date was defined as a date when participants initiated warfarin or apixaban. Follow-up period: the next day of the index date till occurrence of target outcome, discontinuation of the warfarin or apixaban, switching from warfarin or apixaban, withdrawal from the database, whichever observed first. | Eligible participants registered on MDV database, whose data was observed in the study. Analysis was performed using s-IPTW method to balance participant characteristics among reporting groups. Here, "Overall Number of Participants Analyzed" is the number of participants after application of s-IPTW method to raw numbers and is different from the actual participants included in the reporting arm. | Posted | Number | 95% Confidence Interval | Events Per 1000 Participant-Years | Follow-up period during data observation period from 26-Feb-2013 to 31-Dec-2021 (approximately 8 years 10 months); extracted data evaluated in approximately 3.5 months of this study |
| ||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||
| Secondary | Incidence Rate (Per 1,000 Participant-Year) of Intracranial Hemorrhage: Balanced Cohorts | Incidence rate per 1000 participant-years for the first occurrence of intracranial hemorrhage event after index date was reported. ICD-10 diagnosis code was used to label the events. Index date was defined as a date when participants initiated warfarin or apixaban. Follow-up period: the next day of the index date till occurrence of target outcome, discontinuation of the warfarin or apixaban, switching from warfarin or apixaban, withdrawal from the database, whichever observed first. | Eligible participants registered on MDV database, whose data was observed in the study. Analysis was performed using s-IPTW method to balance participant characteristics among reporting groups. Here, "Overall Number of Participants Analyzed" is the number of participants after application of s-IPTW method to raw numbers and is different from the actual participants included in the reporting arm. | Posted | Number | 95% Confidence Interval | Events Per 1000 Participant-Years | Follow-up period during data observation period from 26-Feb-2013 to 31-Dec-2021 (approximately 8 years 10 months); extracted data evaluated in approximately 3.5 months of this study |
| ||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||
| Secondary | Incidence Rate (Per 1,000 Participant-Year) of Gastrointestinal Bleeding: Balanced Cohorts | Incidence rate per 1000 participant-years for the first occurrence of major GI bleeding event after index date was reported. ICD-10 diagnosis code was used to label the events. Index date was defined as a date when participants initiated warfarin or apixaban. Follow-up period: the next day of the index date till occurrence of target outcome, discontinuation of the warfarin or apixaban, switching from warfarin or apixaban, withdrawal from the database, whichever observed first. | Eligible participants registered on MDV database, whose data was observed in the study. Analysis was performed using s-IPTW method to balance participant characteristics among reporting groups. Here, "Overall Number of Participants Analyzed" is the number of participants after application of s-IPTW method to raw numbers and is different from the actual participants included in the reporting arm. | Posted | Number | 95% Confidence Interval | Events Per 1000 Participant-Years | Follow-up period during data observation period from 26-Feb-2013 to 31-Dec-2021 (approximately 8 years 10 months); extracted data evaluated in approximately 3.5 months of this study |
| ||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||
| Secondary | Incidence Rate (Per 1,000 Participant-Year) of Intraocular Bleeding: Balanced Cohorts | Incidence rate per 1000 participant-years for the first occurrence of intraocular bleeding event after index date was reported. ICD-10 diagnosis code was used to label the events. Index date was defined as a date when participants initiated warfarin or apixaban. Follow-up period: the next day of the index date till occurrence of target outcome, discontinuation of the warfarin or apixaban, switching from warfarin or apixaban, withdrawal from the database, whichever observed first. | Eligible participants registered on MDV database, whose data was observed in the study. Analysis was performed using s-IPTW method to balance participant characteristics among reporting groups. Here, "Overall Number of Participants Analyzed" is the number of participants after application of s-IPTW method to raw numbers and is different from the actual participants included in the reporting arm. | Posted | Number | 95% Confidence Interval | Events Per 1000 Participant-Years | Follow-up period during data observation period from 26-Feb-2013 to 31-Dec-2021 (approximately 8 years 10 months); extracted data evaluated in approximately 3.5 months of this study |
|
Not applicable as safety data was not planned to be collected during the study.
This study involved data that existed as structured data by the time of study start. In these data sources, individual participant data was not retrieved or validated, and it was not possible to link (i.e., identify a potential association between) a particular product and medical event for any individual. Thus, the minimum criteria for reporting an adverse event (AE) (i.e., identifiable participant, identifiable reporter, a suspect product, and event) could not be met.
Not provided
| ID | Title | Description | Deaths (Affected) | Deaths (At Risk) | Serious Events (Affected) | Serious Events (At Risk) | Other Events (Affected) | Other Events (At Risk) |
|---|---|---|---|---|---|---|---|---|
| EG000 | Warfarin Cohort | Participants included in this cohort were those who received warfarin in real world practice after getting diagnosed with NVAF. Data of the participants included were retrieved from MDV database and was observed retrospectively in this study. | 0 | 0 | 0 | 0 | 0 | 0 |
| EG001 | Apixaban Cohort | Participants included in this cohort were those who received apixaban in real world practice after getting diagnosed with NVAF. Data of the participants included were retrieved from MDV database and was observed retrospectively in this study. | 0 | 0 | 0 | 0 | 0 | 0 |
Not provided
Not provided
Pfizer has the right to review disclosures, requesting a delay of less than 60 days. Investigator will postpone single center publications until after disclosure of pooled data (all sites), less than 12 months from study completion/termination at all participating sites. Investigator may not disclose previously undisclosed confidential information other than study results.
| Title | Organization | Phone | Extension | |
|---|---|---|---|---|
| Pfizer ClinicalTrials.gov Call Center | Pfizer Inc. | 1-800-718-1021 | ClinicalTrials.gov_Inquiries@pfizer.com |
| Prot_000.pdf |
| SAP | No | Yes | No | Statistical Analysis Plan | Aug 10, 2023 | Oct 2, 2023 | SAP_001.pdf |
| ID | Term |
|---|---|
| D020521 | Stroke |
| ID | Term |
|---|---|
| D002561 | Cerebrovascular Disorders |
| D001927 | Brain Diseases |
| D002493 | Central Nervous System Diseases |
| D009422 | Nervous System Diseases |
| D014652 | Vascular Diseases |
| D002318 | Cardiovascular Diseases |
Not provided
Not provided
| ID | Term |
|---|---|
| D014859 | Warfarin |
| C522181 | apixaban |
| ID | Term |
|---|---|
| D015110 | 4-Hydroxycoumarins |
| D003374 | Coumarins |
| D001578 | Benzopyrans |
| D011714 | Pyrans |
| D006573 | Heterocyclic Compounds, 1-Ring |
| D006571 | Heterocyclic Compounds |
| D006574 | Heterocyclic Compounds, 2-Ring |
| D000072471 | Heterocyclic Compounds, Fused-Ring |
Not provided
Not provided
|
|
| OG001 | Apixaban: Balanced Cohort | Participants included in this cohort were those who received apixaban in real world practice after getting diagnosed with NVAF. Data of the participants included were retrieved from MDV database and was observed retrospectively in this study. S-IPTW method was applied to balance the participant's characteristics. |
|
|
|
| OG001 |
| Apixaban: Balanced Cohort |
Participants included in this cohort were those who received apixaban in real world practice after getting diagnosed with NVAF. Data of the participants included were retrieved from MDV database and was observed retrospectively in this study. S-IPTW method was applied to balance the participant's characteristics. |
|
|
|
| Apixaban: Balanced Cohort |
Participants included in this cohort were those who received apixaban in real world practice after getting diagnosed with NVAF. Data of the participants included were retrieved from MDV database and was observed retrospectively in this study. S-IPTW method was applied to balance the participant's characteristics. |
|
|
|
| Apixaban: Balanced Cohort |
Participants included in this cohort were those who received apixaban in real world practice after getting diagnosed with NVAF. Data of the participants included were retrieved from MDV database and was observed retrospectively in this study. S-IPTW method was applied to balance the participant's characteristics. |
|
|
|
| Apixaban: Balanced Cohort |
Participants included in this cohort were those who received apixaban in real world practice after getting diagnosed with NVAF. Data of the participants included were retrieved from MDV database and was observed retrospectively in this study. S-IPTW method was applied to balance the participant's characteristics. |
|
|
|
| Apixaban: Balanced Cohort |
Participants included in this cohort were those who received apixaban in real world practice after getting diagnosed with NVAF. Data of the participants included were retrieved from MDV database and was observed retrospectively in this study. S-IPTW method was applied to balance the participant's characteristics. |
|
|
|