Trial · NCT03254134
Comparative Effectiveness and Safety Between Warfarin and Dabigatran
NCT03254134, Completed, Boehringer Ingelheim; results first posted 2019-07-09
3 sourcestrials-2026-11-12-0.5.0
Cite this record
ConductScience Library. Comparative Effectiveness and Safety Between Warfarin and Dabigatran. Trials, record NCT03254134. Release trials-2026-11-12-0.5.0, 12 Nov 2026. https://conductscience.org/library/trials/NCT03254134
On this page
Trial
As registered on ClinicalTrials.gov, in the graph's capture of the registry.
- Title
- Comparative Effectiveness and Safety Between Warfarin and Dabigatran
- NCT number
- NCT03254134
- Status
- Completed
- Enrollment
- 22,490 participants, actual
- Lead sponsor
- Boehringer Ingelheim
- Conditions
- Atrial Fibrillation
- Interventions
- Warfarin, Dabigatran
- First posted
- 2017-08-18
- Last updated
- 2019-07-09
- Results first posted
- 2019-07-09
Source ClinicalTrials.gov
Registered outcomes2
Each outcome the trial registered, primary first, in ClinicalTrials.gov's words.
| List | Outcome | Time frame | Description |
|---|---|---|---|
| Primary | Incidence Rate of Stroke and Systemic Embolism (SE) | From the index date to end of treatment with > 14 day grace period, switch to another OAC, end of continuous enrolment, end of study period or death, outcome event of stroke and systemic embolism, ie., up to 6.5 years. | Incidence rate of stroke and systemic embolism (SE). |
| Secondary | Incidence Rate of Major Bleeding | From the index date to end of treatment with > 14 day grace period, switch to another OAC, end of continuous enrolment, end of study period or death, outcome event of major bleeding, ie., up to 6.5 years. | Incidence rate of major bleeding defined by any bleeding event associated with hospitalization claims and/or transfusion claims. |
Source ClinicalTrials.gov
Outcomes2
Each outcome the trial posted results for, in ClinicalTrials.gov's words.
| Type | Outcome | Time frame | Population | Units | Measured as |
|---|---|---|---|---|---|
| PRIMARY | Incidence Rate of Stroke and Systemic Embolism (SE) | From the index date to end of treatment with > 14 day grace period, switch to another OAC, end of continuous enrolment, end of study period or death, outcome event of stroke and systemic embolism, ie., up to 6.5 years. | Eligible patient who were prescribed dabigatran and warfarin as the first OACs and matched 1: 1 using the propensity score matching (PSM). | per patient-year | NUMBER |
| SECONDARY | Incidence Rate of Major Bleeding | From the index date to end of treatment with > 14 day grace period, switch to another OAC, end of continuous enrolment, end of study period or death, outcome event of major bleeding, ie., up to 6.5 years. | Eligible patient who were prescribed dabigatran and warfarin as the first OACs and matched 1: 1 using the propensity score matching (PSM). | per patient-year | NUMBER |
Source ClinicalTrials.gov
Results by group4
Each measurement the trial posted, group by group, in the words and numbers it posted.
| Outcome | Group | Category | Value | Spread | Units |
|---|---|---|---|---|---|
| Incidence Rate of Stroke and Systemic Embolism (SE) | Dabigatran | 2.898 | per patient-year | ||
| Incidence Rate of Stroke and Systemic Embolism (SE) | Warfarin | 3.563 | per patient-year | ||
| Incidence Rate of Major Bleeding | Dabigatran | 0.639 | per patient-year | ||
| Incidence Rate of Major Bleeding | Warfarin | 1.128 | per patient-year |
Source ClinicalTrials.gov
Participant flow6
How many started, completed or left each group, period by period.
| Period | Milestone | Group | Participants | Units counted |
|---|---|---|---|---|
| Overall Study | STARTED | Dabigatran | 5,745 | |
| Overall Study | STARTED | Warfarin | 16,745 | |
| Overall Study | COMPLETED | Dabigatran | 5,146 | |
| Overall Study | COMPLETED | Warfarin | 13,115 | |
| Overall Study | NOT COMPLETED | Dabigatran | 599 | |
| Overall Study | NOT COMPLETED | Warfarin | 3,630 |
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 | Dabigatran | 0 | 0 |
| Total, all-cause mortality | Warfarin | 0 | 0 |
| Total, other adverse events | Dabigatran | 0 | 0 |
| Total, other adverse events | Warfarin | 0 | 0 |
| Total, serious adverse events | Dabigatran | 0 | 0 |
| Total, serious adverse events | 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 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/NCT03254134
GET https://conductscience.org/api/trials/v1/NCT03254134/registered