Trial · NCT05321810
Safety and Effectiveness of Apixaban Compared to Warfarin in Secondary Prevention in Patients With Atrial Fibrillation
NCT05321810, Completed, Pfizer; results first posted 2024-01-11
3 sourcestrials-2026-11-12-0.5.0
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ConductScience Library. Safety and Effectiveness of Apixaban Compared to Warfarin in Secondary Prevention in Patients With Atrial Fibrillation. Trials, record NCT05321810. Release trials-2026-11-12-0.5.0, 12 Nov 2026. https://conductscience.org/library/trials/NCT05321810
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Trial
As registered on ClinicalTrials.gov, in the graph's capture of the registry.
- Title
- Safety and Effectiveness of Apixaban Compared to Warfarin in Secondary Prevention in Patients With Atrial Fibrillation
- NCT number
- NCT05321810
- Status
- Completed
- Enrollment
- 193,565 participants, actual
- Lead sponsor
- Pfizer
- Conditions
- Non-valvular Atrial Fibrillation
- Interventions
- Apixaban, Warfarin
- First posted
- 2022-04-11
- Last updated
- 2024-01-11
- Results first posted
- 2024-01-11
Source ClinicalTrials.gov
Registered outcomes37
Each outcome the trial registered, primary first, in ClinicalTrials.gov's words.
| List | Outcome | Time frame | Description |
|---|---|---|---|
| Primary | Incidence Rate of a Composite of Recurrent Stroke or Systemic Embolism (SE) During the Follow-up Period: Secondary Prevention (Balanced) Cohort | 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 (OAC), switch of OAC, lack of records, occurrence of stroke, SE, or hemorrhagic events, or elapsing of 2 years from index date. |
| 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 | 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". |
| 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 | 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". |
| 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 | 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". |
| 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 | 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". |
| 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 | 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". |
| Primary | Number of Participants With Risk of a Composite of Recurrent Stroke or SE at 0 Month: Secondary Prevention (Balanced) Cohorts | 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". |
| Primary | Number of Participants With Risk of a Composite of Recurrent Stroke or SE at 6 Months: Secondary Prevention (Balanced) Cohorts | 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". |
| Primary | Number of Participants With Risk of a Composite of Recurrent Stroke or SE at 12 Months: Secondary Prevention (Balanced) Cohorts | 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". |
| Primary | Number of Participants With Risk of a Composite of Recurrent Stroke or SE at 18 Months: Secondary Prevention (Balanced) Cohorts | 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". |
1 to 10 of 37Source ClinicalTrials.gov
See all 37 registered outcomesOutcomes37
Each outcome the trial posted results for, in ClinicalTrials.gov's words.
| Type | Outcome | Time frame | Population | Units | Measured as |
|---|---|---|---|---|---|
| PRIMARY | Incidence Rate of a Composite of Recurrent Stroke or Systemic Embolism (SE) During the Follow-up Period: Secondary Prevention (Balanced) Cohort | During follow up period (Data collected between 2008 to 2021 [approximately 13 years]) | Full analysis set included all eligible participants. Analysis was performed using sIPTW method to balance participant characteristics among reporting groups. sIPTW method created balanced virtual groups and hence overall number of participants analyzed is different from numbers in participant flow (not balanced). | Events Per 1000 Participant-Years | NUMBER |
| 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 | 0 month | Full analysis set included all eligible participants. Analysis was performed using sIPTW method to balance participant characteristics among reporting groups. sIPTW method created balanced virtual groups and hence overall number of participants analyzed is different from numbers in participant flow (not balanced). | Probability of being event free | NUMBER |
| 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 | 6 months | Full analysis set included all eligible participants. Analysis was performed using sIPTW method to balance participant characteristics among reporting groups. sIPTW method created balanced virtual groups and hence overall number of participants analyzed is different from numbers in participant flow (not balanced). | Probability of being event free | NUMBER |
| 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 | 12 months | Full analysis set included all eligible participants. Analysis was performed using sIPTW method to balance participant characteristics among reporting groups. sIPTW method created balanced virtual groups and hence overall number of participants analyzed is different from numbers in participant flow (not balanced). | Probability of being event free | NUMBER |
| 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 | 18 months | Full analysis set included all eligible participants. Analysis was performed using sIPTW method to balance participant characteristics among reporting groups. sIPTW method created balanced virtual groups and hence overall number of participants analyzed is different from numbers in participant flow (not balanced). | Probability of being event free | NUMBER |
| 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 | 24 months | Full analysis set included all eligible participants. Analysis was performed using sIPTW method to balance participant characteristics among reporting groups. sIPTW method created balanced virtual groups and hence overall number of participants analyzed is different from numbers in participant flow (not balanced). | Probability of being event free | NUMBER |
| PRIMARY | Number of Participants With Risk of a Composite of Recurrent Stroke or SE at 0 Month: Secondary Prevention (Balanced) Cohorts | 0 month | Full analysis set included all eligible participants. Analysis was performed using sIPTW method to balance participant characteristics among reporting groups. sIPTW method created balanced virtual groups and hence overall number of participants analyzed is different from numbers in participant flow (not balanced). | Participants | COUNT_OF_PARTICIPANTS |
| PRIMARY | Number of Participants With Risk of a Composite of Recurrent Stroke or SE at 6 Months: Secondary Prevention (Balanced) Cohorts | 6 months | Full analysis set included all eligible participants. Analysis was performed using sIPTW method to balance participant characteristics among reporting groups. sIPTW method created balanced virtual groups and hence overall number of participants analyzed is different from numbers in participant flow (not balanced). | Participants | COUNT_OF_PARTICIPANTS |
| PRIMARY | Number of Participants With Risk of a Composite of Recurrent Stroke or SE at 12 Months: Secondary Prevention (Balanced) Cohorts | 12 months | Full analysis set included all eligible participants. Analysis was performed using sIPTW method to balance participant characteristics among reporting groups. sIPTW method created balanced virtual groups and hence overall number of participants analyzed is different from numbers in participant flow (not balanced). | Participants | COUNT_OF_PARTICIPANTS |
| PRIMARY | Number of Participants With Risk of a Composite of Recurrent Stroke or SE at 18 Months: Secondary Prevention (Balanced) Cohorts | 18 months | Full analysis set included all eligible participants. Analysis was performed using sIPTW method to balance participant characteristics among reporting groups. sIPTW method created balanced virtual groups and hence overall number of participants analyzed is different from numbers in participant flow (not balanced). | Participants | COUNT_OF_PARTICIPANTS |
1 to 10 of 37Source ClinicalTrials.gov
See all 37 outcomesResults by group154
Each measurement the trial posted, group by group, in the words and numbers it posted.
| Outcome | Group | Category | Value | Spread | Units |
|---|---|---|---|---|---|
| Incidence Rate of a Composite of Recurrent Stroke or Systemic Embolism (SE) During the Follow-up Period: Secondary Prevention (Balanced) Cohort | Secondary Prevention Cohort (Balanced): Apixaban | 41.217 | 95% Confidence Interval 36.274 to 46.834 | Events Per 1000 Participant-Years | |
| Incidence Rate of a Composite of Recurrent Stroke or Systemic Embolism (SE) During the Follow-up Period: Secondary Prevention (Balanced) Cohort | Secondary Prevention Cohort (Balanced): Warfarin | 50.581 | 95% Confidence Interval 45.658 to 56.034 | Events Per 1000 Participant-Years | |
| 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 | Secondary Prevention Cohort (Balanced): Apixaban | 1.000 | 95% Confidence Interval 1.000 to 1.000 | Probability of being event free | |
| 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 | Secondary Prevention Cohort (Balanced): Warfarin | 1.000 | 95% Confidence Interval 1.000 to 1.000 | Probability of being event free | |
| 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 | Secondary Prevention Cohort (Balanced): Apixaban | 0.971 | 95% Confidence Interval 0.966 to 0.976 | Probability of being event free | |
| 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 | Secondary Prevention Cohort (Balanced): Warfarin | 0.967 | 95% Confidence Interval 0.961 to 0.972 | Probability of being event free | |
| 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 | Secondary Prevention Cohort (Balanced): Apixaban | 0.953 | 95% Confidence Interval 0.946 to 0.960 | Probability of being event free | |
| 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 | Secondary Prevention Cohort (Balanced): Warfarin | 0.948 | 95% Confidence Interval 0.938 to 0.956 | Probability of being event free | |
| 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 | Secondary Prevention Cohort (Balanced): Apixaban | 0.942 | 95% Confidence Interval 0.933 to 0.951 | Probability of being event free | |
| 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 | Secondary Prevention Cohort (Balanced): Warfarin | 0.932 | 95% Confidence Interval 0.920 to 0.943 | Probability of being event free |
1 to 10 of 154Source ClinicalTrials.gov
See all 154 results by groupParticipant flow12
How many started, completed or left each group, period by period.
| Period | Milestone | Group | Participants | Units counted |
|---|---|---|---|---|
| Overall Study | STARTED | Primary Prevention Cohort: Apixaban | 57,560 | |
| Overall Study | STARTED | Primary Prevention Cohort: Warfarin | 90,636 | |
| Overall Study | STARTED | Secondary Prevention Cohort: Apixaban | 18,216 | |
| Overall Study | STARTED | Secondary Prevention Cohort: Warfarin | 27,153 | |
| Overall Study | COMPLETED | Primary Prevention Cohort: Apixaban | 57,560 | |
| Overall Study | COMPLETED | Primary Prevention Cohort: Warfarin | 90,636 | |
| Overall Study | COMPLETED | Secondary Prevention Cohort: Apixaban | 18,216 | |
| Overall Study | COMPLETED | Secondary Prevention Cohort: Warfarin | 27,153 | |
| Overall Study | NOT COMPLETED | Primary Prevention Cohort: Apixaban | 0 | |
| Overall Study | NOT COMPLETED | Primary Prevention Cohort: Warfarin | 0 |
1 to 10 of 12Source ClinicalTrials.gov
See all 12 participant flowAdverse 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 | Secondary Prevention Cohort: Apixaban | 0 | 0 |
| Total, all-cause mortality | Secondary Prevention Cohort: Warfarin | 0 | 0 |
| Total, other adverse events | Secondary Prevention Cohort: Apixaban | 0 | 0 |
| Total, other adverse events | Secondary Prevention Cohort: Warfarin | 0 | 0 |
| Total, serious adverse events | Secondary Prevention Cohort: Apixaban | 0 | 0 |
| Total, serious adverse events | Secondary Prevention Cohort: Warfarin | 0 | 0 |
Source ClinicalTrials.gov
Papers0
The papers the trial lists on ClinicalTrials.gov.
None in this release.
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 comparisons10
Comparisons of the trial's two groups, calculated by ConductScience from the counts it posted.
| Comparison | Source |
|---|---|
Secondary Prevention Cohort (Balanced): Apixaban vs Secondary Prevention Cohort (Balanced): Warfarin: Number of Participants With Risk of a Composite of Recurrent Stroke or SE at 18 Months: Secondary Prevention (Balanced) Cohorts | Trial comparisons |
Secondary Prevention Cohort (Balanced): Apixaban vs Secondary Prevention Cohort (Balanced): Warfarin: Number of Participants With Risk of a Composite of Recurrent Stroke or SE at 6 Months: Secondary Prevention (Balanced) Cohorts | Trial comparisons |
Secondary Prevention Cohort (Balanced): Apixaban vs Secondary Prevention Cohort (Balanced): Warfarin: Number of Participants With Risk of a Composite of Recurrent Stroke or SE at 0 Month: Secondary Prevention (Balanced) Cohorts | Trial comparisons |
Secondary Prevention Cohort (Balanced): Apixaban vs Secondary Prevention Cohort (Balanced): Warfarin: Number of Participants With Risk of Major Bleeding at 18 Months: Secondary Prevention (Balanced) Cohorts | Trial comparisons |
Secondary Prevention Cohort (Balanced): Apixaban vs Secondary Prevention Cohort (Balanced): Warfarin: Number of Participants With Risk of Major Bleeding at 24 Months: Secondary Prevention (Balanced) Cohorts | Trial comparisons |
Secondary Prevention Cohort (Balanced): Apixaban vs Secondary Prevention Cohort (Balanced): Warfarin: Number of Participants With Risk of Major Bleeding at 0 Month: Secondary Prevention (Balanced) Cohorts | Trial comparisons |
Secondary Prevention Cohort (Balanced): Apixaban vs Secondary Prevention Cohort (Balanced): Warfarin: Number of Participants With Risk of a Composite of Recurrent Stroke or SE at 24 Months: Secondary Prevention (Balanced) Cohorts | Trial comparisons |
Secondary Prevention Cohort (Balanced): Apixaban vs Secondary Prevention Cohort (Balanced): Warfarin: Number of Participants With Risk of a Composite of Recurrent Stroke or SE at 12 Months: Secondary Prevention (Balanced) Cohorts | Trial comparisons |
Secondary Prevention Cohort (Balanced): Apixaban vs Secondary Prevention Cohort (Balanced): Warfarin: Number of Participants With Risk of Major Bleeding at 12 Months: Secondary Prevention (Balanced) Cohorts | Trial comparisons |
Secondary Prevention Cohort (Balanced): Apixaban vs Secondary Prevention Cohort (Balanced): Warfarin: Number of Participants With Risk of Major Bleeding at 6 Months: Secondary Prevention (Balanced) Cohorts | Trial comparisons |
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/NCT05321810
GET https://conductscience.org/api/trials/v1/NCT05321810/registered?page=2