Trial · NCT03026556
The Comparative Safety and Effectiveness of Dabigatran, Versus Rivaroxaban, and Apixaban Utilized in the Department of Defense Non-Valvular Atrial Fibrillation Patient Population: A Retrospective Database Analysis
NCT03026556, Completed, Boehringer Ingelheim; results first posted 2019-06-03
3 sourcestrials-2026-11-12-0.5.0
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ConductScience Library. The Comparative Safety and Effectiveness of Dabigatran, Versus Rivaroxaban, and Apixaban Utilized in the Department of Defense Non-Valvular Atrial Fibrillation Patient Population: A Retrospective Database Analysis. Trials, record NCT03026556. Release trials-2026-11-12-0.5.0, 12 Nov 2026. https://conductscience.org/library/trials/NCT03026556
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Trial
As registered on ClinicalTrials.gov, in the graph's capture of the registry.
- Title
The Comparative Safety and Effectiveness of Dabigatran, Versus Rivaroxaban, and Apixaban Utilized in the Department of Defense Non-Valvular Atrial Fibrillation Patient Population: A Retrospective Database Analysis
- NCT number
- NCT03026556
- Status
- Completed
- Enrollment
- 42,534 participants, actual
- Lead sponsor
- Boehringer Ingelheim
- Conditions
- Atrial Fibrillation
- Interventions
- Dabigatran vs. Rivaroxaban, Dabigatran vs. Apixaban
- First posted
- 2017-01-20
- Last updated
- 2019-06-03
- Results first posted
- 2019-06-03
Source ClinicalTrials.gov
Registered outcomes13
Each outcome the trial registered, primary first, in ClinicalTrials.gov's words.
| List | Outcome | Time frame | Description |
|---|---|---|---|
| Primary | Stroke Overall (Hemorrhagic, Ischemic, Uncertain) | Baseline (July 1, 2010) until end of the observation period (June 30, 2016), 6 Years | The event rate of overall stroke (hemorrhagic, ischemic, uncertain) in patients matched on propensity scores without index year. Event rates were calculated as the total number of patients in each treatment group who had the outcome during follow-up divided by the total person-years at risk in the cohort. Length of Follow-up: The post-index follow-up period began the day following the NOAC index date and ended on whichever of the following occurred earliest: 1. The day of discontinuation of the index NOAC exposure; 2. The day before a switch to an anticoagulant different from the index exposure; 3. The day before a change in dose for the index NOAC; 4. The end of continuous eligibility of a patient in the health plan (disenrollment); 5. The end of the study observation period; or 6. The date of death of the patient. |
| Primary | Overall Major Bleeding | Baseline (July 1, 2010) until end of the observation period (June 30, 2016), 6 Years | The event rate of overall Major bleeding (Hemorrhagic Stroke, Major Intracranial Bleeding and Major Extracranial Bleeding) in patients matched on propensity scores without index year. Event rates were calculated as the total number of patients in each treatment group who had the outcome during follow-up divided by the total person-years at risk in the cohort. Follow-up time was the time elapsed from the index date to the date of the outcome of interest, disenrollment, end of the observation period (available data), death, discontinuation of the NOAC, or switch to a different NOAC, whichever came first. |
| Secondary | Ischemic Stroke | Baseline (July 1, 2010) until end of the observation period (June 30, 2016), 6 Years | The event rate of ischemic stroke in patients matched on propensity scores without index year. Event rates were calculated as the total number of patients in each treatment group who had the outcome during follow-up divided by the total person-years at risk in the cohort. Follow-up time was the time elapsed from the index date to the date of the outcome of interest, disenrollment, end of the observation period (available data), death, discontinuation of the NOAC, or switch to a different NOAC, whichever came first |
| Secondary | Hemorrhagic Stroke | Baseline (July 1, 2010) until end of the observation period (June 30, 2016), 6 Years | The event rate of Hemorrhagic stroke in patients matched on propensity scores without index year. Event rates were calculated as the total number of patients in each treatment group who had the outcome during follow-up divided by the total person-years at risk in the cohort. Follow-up time was the time elapsed from the index date to the date of the outcome of interest, disenrollment, end of the observation period (available data), death, discontinuation of the NOAC, or switch to a different NOAC, whichever came first. |
| Secondary | Major Intracranial Bleeding | Baseline (July 1, 2010) until end of the observation period (June 30, 2016), 6 Years | The event rate of major intracranial bleeding in patients matched on propensity scores without index year. Event rates were calculated as the total number of patients in each treatment group who had the outcome during follow-up divided by the total person-years at risk in the cohort. Follow-up time was the time elapsed from the index date to the date of the outcome of interest, disenrollment, end of the observation period (available data), death, discontinuation of the NOAC, or switch to a different NOAC, whichever came first |
| Secondary | Major Extracranial Bleeding | Baseline (July 1, 2010) until end of the observation period (June 30, 2016), 6 Years | The event rate of major extracranial bleeding (Major GI bleeding, Major urogenital bleeding and Major other bleeding) in patients matched on propensity scores without index year. Event rates were calculated as the total number of patients in each treatment group who had the outcome during follow-up divided by the total person-years at risk in the cohort. Follow-up time was the time elapsed from the index date to the date of the outcome of interest, disenrollment, end of the observation period (available data), death, discontinuation of the NOAC, or switch to a different NOAC, whichever came first |
| Secondary | Major GI Bleeding | Baseline (July 1, 2010) until end of the observation period (June 30, 2016), 6 Years | The event rate of major GI bleeding (Upper GI Bleeding and Lower GI Bleeding) in patients matched on propensity scores without index year. Event rates were calculated as the total number of patients in each treatment group who had the outcome during follow-up divided by the total person-years at risk in the cohort. Follow-up time was the time elapsed from the index date to the date of the outcome of interest, disenrollment, end of the observation period (available data), death, discontinuation of the NOAC, or switch to a different NOAC, whichever came first |
| Secondary | Major Urogenital Bleeding | Baseline (July 1, 2010) until end of the observation period (June 30, 2016), 6 Years | The event rate of major urogenital bleeding in patients matched on propensity scores without index year. Event rates were calculated as the total number of patients in each treatment group who had the outcome during follow-up divided by the total person-years at risk in the cohort. Follow-up time was the time elapsed from the index date to the date of the outcome of interest, disenrollment, end of the observation period (available data), death, discontinuation of the NOAC, or switch to a different NOAC, whichever came first. |
| Secondary | Major Other Bleeding | Baseline (July 1, 2010) until end of the observation period (June 30, 2016), 6 Years | The event rate of major other bleeding in patients matched on propensity scores without index year. Event rates were calculated as the total number of patients in each treatment group who had the outcome during follow-up divided by the total person-years at risk in the cohort. Follow-up time was the time elapsed from the index date to the date of the outcome of interest, disenrollment, end of the observation period (available data), death, discontinuation of the NOAC, or switch to a different NOAC, whichever came first |
| Secondary | Upper GI Bleeding | Baseline (July 1, 2010) until end of the observation period (June 30, 2016), 6 Years | The event rate of Upper GI Bleeding in patients matched on propensity scores without index year. Event rates were calculated as the total number of patients in each treatment group who had the outcome during follow-up divided by the total person-years at risk in the cohort. Follow-up time was the time elapsed from the index date to the date of the outcome of interest, disenrollment, end of the observation period (available data), death, discontinuation of the NOAC, or switch to a different NOAC, whichever came first |
1 to 10 of 13Source ClinicalTrials.gov
See all 13 registered outcomesOutcomes13
Each outcome the trial posted results for, in ClinicalTrials.gov's words.
| Type | Outcome | Time frame | Population | Units | Measured as |
|---|---|---|---|---|---|
| PRIMARY | Stroke Overall (Hemorrhagic, Ischemic, Uncertain) | Baseline (July 1, 2010) until end of the observation period (June 30, 2016), 6 Years | Based on Department of Defense (DoD) outpatient prescription dispensed data the two separate study cohorts dabigatran vs rivaroxaban cohort and dabigatran vs apixaban cohort were formed. In both cohorts, dabigatran patients were matched 1:1 to comparator patients based on their baseline characteristics using the propensity score matching (PSM). | Event Rate in 100 person-years | NUMBER |
| PRIMARY | Overall Major Bleeding | Baseline (July 1, 2010) until end of the observation period (June 30, 2016), 6 Years | Based on Department of Defense (DoD) outpatient prescription dispensed data the two separate study cohorts dabigatran vs rivaroxaban cohort and dabigatran vs apixaban cohort were formed and matched 1: 1 based on their baseline characteristics using the propensity score matching (PSM). | Event Rate in 100 person-years | NUMBER |
| SECONDARY | Ischemic Stroke | Baseline (July 1, 2010) until end of the observation period (June 30, 2016), 6 Years | Based on Department of Defense (DoD) outpatient prescription dispensed data the two separate study cohorts dabigatran vs rivaroxaban cohort and dabigatran vs apixaban cohort were formed and matched 1: 1 based on their baseline characteristics using the propensity score matching (PSM). | Event Rate in 100 person-years | NUMBER |
| SECONDARY | Hemorrhagic Stroke | Baseline (July 1, 2010) until end of the observation period (June 30, 2016), 6 Years | Based on Department of Defense (DoD) outpatient prescription dispensed data the two separate study cohorts dabigatran vs rivaroxaban cohort and dabigatran vs apixaban cohort were formed and matched 1: 1 based on their baseline characteristics using the propensity score matching (PSM). | Event Rate in 100 person-years | NUMBER |
| SECONDARY | Major Intracranial Bleeding | Baseline (July 1, 2010) until end of the observation period (June 30, 2016), 6 Years | Based on Department of Defense (DoD) outpatient prescription dispensed data the two separate study cohorts dabigatran vs rivaroxaban cohort and dabigatran vs apixaban cohort were formed and matched 1: 1 based on their baseline characteristics using the propensity score matching (PSM). | Event Rate in 100 person-years | NUMBER |
| SECONDARY | Major Extracranial Bleeding | Baseline (July 1, 2010) until end of the observation period (June 30, 2016), 6 Years | Based on Department of Defense (DoD) outpatient prescription dispensed data the two separate study cohorts dabigatran vs rivaroxaban cohort and dabigatran vs apixaban cohort were formed and matched 1: 1 based on their baseline characteristics using the propensity score matching (PSM). | Event Rate in 100 person-years | NUMBER |
| SECONDARY | Major GI Bleeding | Baseline (July 1, 2010) until end of the observation period (June 30, 2016), 6 Years | Based on Department of Defense (DoD) outpatient prescription dispensed data the two separate study cohorts dabigatran vs rivaroxaban cohort and dabigatran vs apixaban cohort were formed and matched 1: 1 based on their baseline characteristics using the propensity score matching (PSM). | Event Rate in 100 person-years | NUMBER |
| SECONDARY | Major Urogenital Bleeding | Baseline (July 1, 2010) until end of the observation period (June 30, 2016), 6 Years | Based on Department of Defense (DoD) outpatient prescription dispensed data the two separate study cohorts dabigatran vs rivaroxaban cohort and dabigatran vs apixaban cohort were formed and matched 1: 1 based on their baseline characteristics using the propensity score matching (PSM). | Event Rate in 100 person-years | NUMBER |
| SECONDARY | Major Other Bleeding | Baseline (July 1, 2010) until end of the observation period (June 30, 2016), 6 Years | Based on Department of Defense (DoD) outpatient prescription dispensed data the two separate study cohorts dabigatran vs rivaroxaban cohort and dabigatran vs apixaban cohort were formed and matched 1: 1 based on their baseline characteristics using the propensity score matching (PSM). | Event Rate in 100 person-years | NUMBER |
| SECONDARY | Upper GI Bleeding | Baseline (July 1, 2010) until end of the observation period (June 30, 2016), 6 Years | Based on Department of Defense (DoD) outpatient prescription dispensed data the two separate study cohorts dabigatran vs rivaroxaban cohort and dabigatran vs apixaban cohort were formed and matched 1: 1 based on their baseline characteristics using the propensity score matching (PSM). | Event Rate in 100 person-years | NUMBER |
1 to 10 of 13Source ClinicalTrials.gov
See all 13 outcomesResults by group52
Each measurement the trial posted, group by group, in the words and numbers it posted.
| Outcome | Group | Category | Value | Spread | Units |
|---|---|---|---|---|---|
| Stroke Overall (Hemorrhagic, Ischemic, Uncertain) | Dabigatran (Dabigatran vs Rivaroxaban) | 0.52 | 95% Confidence Interval 0.41 to 0.66 | Event Rate in 100 person-years | |
| Stroke Overall (Hemorrhagic, Ischemic, Uncertain) | Rivaroxaban (Dabigatran vs Rivaroxaban) | 0.69 | 95% Confidence Interval 0.56 to 0.84 | Event Rate in 100 person-years | |
| Stroke Overall (Hemorrhagic, Ischemic, Uncertain) | Dabigatran (Dabigatran vs Apixaban) | 0.46 | 95% Confidence Interval 0.28 to 0.70 | Event Rate in 100 person-years | |
| Stroke Overall (Hemorrhagic, Ischemic, Uncertain) | Apixaban (Dabigatran vs Apixaban) | 0.36 | 95% Confidence Interval 0.21 to 0.58 | Event Rate in 100 person-years | |
| Overall Major Bleeding | Dabigatran (Dabigatran vs Rivaroxaban) | 1.82 | 95% Confidence Interval 1.60 to 2.05 | Event Rate in 100 person-years | |
| Overall Major Bleeding | Rivaroxaban (Dabigatran vs Rivaroxaban) | 2.24 | 95% Confidence Interval 2.00 to 2.49 | Event Rate in 100 person-years | |
| Overall Major Bleeding | Dabigatran (Dabigatran vs Apixaban) | 1.69 | 95% Confidence Interval 1.33 to 2.11 | Event Rate in 100 person-years | |
| Overall Major Bleeding | Apixaban (Dabigatran vs Apixaban) | 1.24 | 95% Confidence Interval 0.94 to 1.60 | Event Rate in 100 person-years | |
| Ischemic Stroke | Dabigatran (Dabigatran vs Rivaroxaban) | 0.5 | 95% Confidence Interval 0.39 to 0.62 | Event Rate in 100 person-years | |
| Ischemic Stroke | Rivaroxaban (Dabigatran vs Rivaroxaban) | 0.54 | 95% Confidence Interval 0.42 to 0.67 | Event Rate in 100 person-years |
1 to 10 of 52Source ClinicalTrials.gov
See all 52 results by groupParticipant flow9
How many started, completed or left each group, period by period.
| Period | Milestone | Group | Participants | Units counted |
|---|---|---|---|---|
| Overall Study | STARTED | Dabigatran | 12,763 | |
| Overall Study | STARTED | Rivaroxaban | 17,177 | |
| Overall Study | STARTED | Apixaban | 12,594 | |
| Overall Study | COMPLETED | Dabigatran | 12,763 | |
| Overall Study | COMPLETED | Rivaroxaban | 17,177 | |
| Overall Study | COMPLETED | Apixaban | 12,594 | |
| Overall Study | NOT COMPLETED | Dabigatran | 0 | |
| Overall Study | NOT COMPLETED | Rivaroxaban | 0 | |
| Overall Study | NOT COMPLETED | Apixaban | 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 totals9
The totals the trial posted for each group.
| Total | Group | Affected | At risk |
|---|---|---|---|
| Total, all-cause mortality | Dabigatran | 0 | 0 |
| Total, all-cause mortality | Rivaroxaban | 0 | 0 |
| Total, all-cause mortality | Apixaban | 0 | 0 |
| Total, other adverse events | Dabigatran | 0 | 0 |
| Total, other adverse events | Rivaroxaban | 0 | 0 |
| Total, other adverse events | Apixaban | 0 | 0 |
| Total, serious adverse events | Dabigatran | 0 | 0 |
| Total, serious adverse events | Rivaroxaban | 0 | 0 |
| Total, serious adverse events | Apixaban | 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 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/NCT03026556
GET https://conductscience.org/api/trials/v1/NCT03026556/results?page=2