Trial · NCT05438888
Safety and Effectiveness of Apixaban in Very Elderly Patients With Non-valvular Atrial Fibrillation (NVAF) Compared to Warfarin Using Administrative Claims Data
NCT05438888, Completed, Pfizer; results first posted 2024-05-20
3 sourcestrials-2026-11-12-0.5.0
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ConductScience Library. Safety and Effectiveness of Apixaban in Very Elderly Patients With Non-valvular Atrial Fibrillation (NVAF) Compared to Warfarin Using Administrative Claims Data. Trials, record NCT05438888. Release trials-2026-11-12-0.5.0, 12 Nov 2026. https://conductscience.org/library/trials/NCT05438888
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Trial
As registered on ClinicalTrials.gov, in the graph's capture of the registry.
- Title
- Safety and Effectiveness of Apixaban in Very Elderly Patients With Non-valvular Atrial Fibrillation (NVAF) Compared to Warfarin Using Administrative Claims Data
- NCT number
- NCT05438888
- Status
- Completed
- Enrollment
- 77,814 participants, actual
- Lead sponsor
- Pfizer
- Conditions
- Non-valvular Atrial Fibrillation
- Interventions
- Warfarin, Apixaban
- First posted
- 2022-06-30
- Last updated
- 2024-05-20
- Results first posted
- 2024-05-20
Source ClinicalTrials.gov
Registered outcomes7
Each outcome the trial registered, primary first, in ClinicalTrials.gov's words.
| List | Outcome | Time frame | Description |
|---|---|---|---|
| Primary | Incidence Rate (Per 1,000 Participant-Year) of Composite of Stroke and Systemic Embolism (SE): Balanced Cohorts | 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 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. |
| Primary | Incidence Rate (Per 1,000 Participant-Year) of Major Bleeding: Balanced Cohorts | 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 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. |
| Secondary | Incidence Rate (Per 1,000 Participant-Year) of Cardiogenic Cerebral Embolism: Balanced Cohorts | 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 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. |
| Secondary | Incidence Rate (Per 1,000 Participant-Year) of Ischemic Stroke (Cerebral Infarction): Balanced Cohorts | 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 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. |
| Secondary | Incidence Rate (Per 1,000 Participant-Year) of Intracranial Hemorrhage: Balanced Cohorts | 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 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. |
| Secondary | Incidence Rate (Per 1,000 Participant-Year) of Gastrointestinal Bleeding: Balanced Cohorts | 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 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. |
| Secondary | Incidence Rate (Per 1,000 Participant-Year) of Intraocular Bleeding: Balanced Cohorts | 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 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. |
Source ClinicalTrials.gov
Outcomes7
Each outcome the trial posted results for, in ClinicalTrials.gov's words.
| Type | Outcome | Time frame | Population | Units | Measured as |
|---|---|---|---|---|---|
| PRIMARY | Incidence Rate (Per 1,000 Participant-Year) of Composite of Stroke and Systemic Embolism (SE): Balanced Cohorts | 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 | 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. | Events Per 1000 Participant-Years | NUMBER |
| PRIMARY | Incidence Rate (Per 1,000 Participant-Year) of Major Bleeding: Balanced Cohorts | 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 | 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. | Events Per 1000 Participant-Years | NUMBER |
| SECONDARY | Incidence Rate (Per 1,000 Participant-Year) of Cardiogenic Cerebral Embolism: Balanced Cohorts | 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 | 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. | Events Per 1000 Participant-Years | NUMBER |
| SECONDARY | Incidence Rate (Per 1,000 Participant-Year) of Ischemic Stroke (Cerebral Infarction): Balanced Cohorts | 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 | 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. | Events Per 1000 Participant-Years | NUMBER |
| SECONDARY | Incidence Rate (Per 1,000 Participant-Year) of Intracranial Hemorrhage: Balanced Cohorts | 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 | 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. | Events Per 1000 Participant-Years | NUMBER |
| SECONDARY | Incidence Rate (Per 1,000 Participant-Year) of Gastrointestinal Bleeding: Balanced Cohorts | 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 | 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. | Events Per 1000 Participant-Years | NUMBER |
| SECONDARY | Incidence Rate (Per 1,000 Participant-Year) of Intraocular Bleeding: Balanced Cohorts | 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 | 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. | Events Per 1000 Participant-Years | NUMBER |
Source ClinicalTrials.gov
Results by group14
Each measurement the trial posted, group by group, in the words and numbers it posted.
| Outcome | Group | Category | Value | Spread | Units |
|---|---|---|---|---|---|
| Incidence Rate (Per 1,000 Participant-Year) of Composite of Stroke and Systemic Embolism (SE): Balanced Cohorts | Warfarin: Balanced Cohort | 75.227 | 95% Confidence Interval 72.579 to 77.972 | Events Per 1000 Participant-Years | |
| Incidence Rate (Per 1,000 Participant-Year) of Composite of Stroke and Systemic Embolism (SE): Balanced Cohorts | Apixaban: Balanced Cohort | 55.801 | 95% Confidence Interval 53.328 to 58.388 | Events Per 1000 Participant-Years | |
| Incidence Rate (Per 1,000 Participant-Year) of Major Bleeding: Balanced Cohorts | Warfarin: Balanced Cohort | 25.328 | 95% Confidence Interval 23.836 to 26.914 | Events Per 1000 Participant-Years | |
| Incidence Rate (Per 1,000 Participant-Year) of Major Bleeding: Balanced Cohorts | Apixaban: Balanced Cohort | 17.306 | 95% Confidence Interval 15.973 to 18.751 | Events Per 1000 Participant-Years | |
| Incidence Rate (Per 1,000 Participant-Year) of Cardiogenic Cerebral Embolism: Balanced Cohorts | Warfarin: Balanced Cohort | 21.386 | 95% Confidence Interval 20.024 to 22.841 | Events Per 1000 Participant-Years | |
| Incidence Rate (Per 1,000 Participant-Year) of Cardiogenic Cerebral Embolism: Balanced Cohorts | Apixaban: Balanced Cohort | 13.473 | 95% Confidence Interval 12.306 to 14.751 | Events Per 1000 Participant-Years | |
| Incidence Rate (Per 1,000 Participant-Year) of Ischemic Stroke (Cerebral Infarction): Balanced Cohorts | Warfarin: Balanced Cohort | 39.607 | 95% Confidence Interval 37.713 to 41.596 | Events Per 1000 Participant-Years | |
| Incidence Rate (Per 1,000 Participant-Year) of Ischemic Stroke (Cerebral Infarction): Balanced Cohorts | Apixaban: Balanced Cohort | 33.279 | 95% Confidence Interval 31.395 to 35.277 | Events Per 1000 Participant-Years | |
| Incidence Rate (Per 1,000 Participant-Year) of Intracranial Hemorrhage: Balanced Cohorts | Warfarin: Balanced Cohort | 20.787 | 95% Confidence Interval 19.443 to 22.223 | Events Per 1000 Participant-Years | |
| Incidence Rate (Per 1,000 Participant-Year) of Intracranial Hemorrhage: Balanced Cohorts | Apixaban: Balanced Cohort | 13.138 | 95% Confidence Interval 11.988 to 14.399 | Events Per 1000 Participant-Years |
1 to 10 of 14Source ClinicalTrials.gov
See all 14 results by groupParticipant flow6
How many started, completed or left each group, period by period.
| Period | Milestone | Group | Participants | Units counted |
|---|---|---|---|---|
| Overall Study | STARTED | Warfarin Cohort | 39,936 | |
| Overall Study | STARTED | Apixaban Cohort | 37,878 | |
| Overall Study | COMPLETED | Warfarin Cohort | 39,936 | |
| Overall Study | COMPLETED | Apixaban Cohort | 37,878 | |
| Overall Study | NOT COMPLETED | Warfarin Cohort | 0 | |
| Overall Study | NOT COMPLETED | Apixaban Cohort | 0 |
Source ClinicalTrials.gov
Adverse events0
Each adverse event the trial posted, group by group: the participants affected out of those at risk.
None in this release.
Adverse event totals6
The totals the trial posted for each group.
| Total | Group | Affected | At risk |
|---|---|---|---|
| Total, all-cause mortality | Warfarin Cohort | 0 | 0 |
| Total, all-cause mortality | Apixaban Cohort | 0 | 0 |
| Total, other adverse events | Warfarin Cohort | 0 | 0 |
| Total, other adverse events | Apixaban Cohort | 0 | 0 |
| Total, serious adverse events | Warfarin Cohort | 0 | 0 |
| Total, serious adverse events | Apixaban Cohort | 0 | 0 |
Source ClinicalTrials.gov
Papers1
The papers the trial lists on ClinicalTrials.gov.
| PMID | Listed as |
|---|---|
| 40627071 | DERIVED |
Source PubMed
Grants0
The grants NIH RePORTER links to the trial, newest funded first: NIH's, and some of AHRQ's, CDC's, FDA's and VA's. Each shows its title, principal investigators, organization and funder in its newest year.
None in this release.
Trial comparisons0
Comparisons of the trial's two groups, calculated by ConductScience from the counts it posted.
None in this release.
Tests0
The ConductCognition tests this trial's registered outcomes name, as ScienceGraph matched them in trial-tests-2026-11-12-0.2.1.
None in this release.
Data dates
The day each source was copied for this release.
Sources 3
- ClinicalTrials.gov's posted results, through CTTI's AACTFreely available. Acknowledgement requested
- ClinicalTrials.govNo license stated
- NIH RePORTER's clinical studies and project filesPublic domain
Each source's terms
- ClinicalTrials.gov's posted results, through CTTI's AACTClinicalTrials.gov data via Aggregate Analysis of ClinicalTrials.gov (AACT), CTTI. CTTI makes its materials freely available and requests acknowledgement. https://aact.ctti-clinicaltrials.org/documentation/299
- ClinicalTrials.govnone stated
- NIH RePORTER's clinical studies and project filesPublic domain (NIH RePORTER)
ClinicalTrials.gov's data carry an international copyright outside the United States: https://clinicaltrials.gov/about-site/terms-conditions.
For software
Read this trial from software.
The record and each of its lists are JSON, twenty rows a page. No key.
GET https://conductscience.org/api/trials/v1/NCT05438888
GET https://conductscience.org/api/trials/v1/NCT05438888/registered