An observational study in Atrial Fibrillation, sponsored by Boehringer Ingelheim. Completed at 1 site in Japan. Open to participants aged 18 Years and older. Per ClinicalTrials.gov, last updated 2019-07-09.
Sponsored by Boehringer Ingelheim · Observational
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Among 45 studies in Atrial Fibrillation by Boehringer Ingelheim — none open to participants now, none under way, none of them phase 3. Atrial Fibrillation · Boehringer Ingelheim.
Among the 45 studies in Atrial Fibrillation by Boehringer Ingelheim, this one is the 13th largest by enrollment of the 36 observational ones that give a count, is one of 7 that started in 2017, is one of 36 observational ones, and was the 40th registered.
4,009 studies on the registry are indexed under Atrial Fibrillation; 960 are open to participants now.
Browse Atrial Fibrillation studies →None of the 45 studies in Atrial Fibrillation by Boehringer Ingelheim is open now. The open studies under Atrial Fibrillation, anywhere →
Of the 611 Atrial Fibrillation studies recruiting now, 407 (67%) set no upper age limit and 43 (7%) stop at 75 or younger; 21 take children under 18; 43 take healthy volunteers.
This study: 18 Years and older · all sexes · no healthy volunteers.
The full table on the hub →This tab as a report to print or save as PDF → With an account.
45 studies; the count open now beside each. This study's row is marked.
First in 2003; this study’s year is marked. 7 started in 2017.
By drug class, each counting the studies that test any of its medicines:
This study's enrollment of 22,490 is above the median of 300 across 1,400 observational studies indexed under Atrial Fibrillation.
Median enrollment 678 across the 9 interventional studies, 5,000 across the 36 observational. Of the 45 that completed or were terminated, 44 (98%) have results posted.
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Boehringer Ingelheim is the lead sponsor of 2,304 studies on the registry; 61 are open to participants now.
Of its 169 completed or terminated interventional studies of FDA-regulated products, 123 (73%) have results posted.
None of the studies under way reaches primary completion within a year.
Among the 45 studies in Atrial Fibrillation by Boehringer Ingelheim, from their registry updates:
Nothing recorded among them since 2026-09-25.
This tab as a report to print or save as PDF → With an account.
This is a comparative effectiveness and safety study of clinical events among patients taking either dabigatran or warfarin. There is no formal hypothesis to be tested, but rather to provide the estimates on the incidence of stroke and systemic embolism (effectiveness) and bleeding events (safety) using 95% confidence interval for comparison between those non0-valvular atrial fibrillation patients taking dabigatran vs. warfarin using a large, nation-wide claims data in Japan.
This is a comparative effectiveness and safety study of clinical events among patients taking either dabigatran or warfarin. There is no formal hypothesis to be tested, but rather to provide the estimates on the incidence of stroke and systemic embolism (effectiveness) and bleeding events (safety) using 95% confidence interval for comparison between those non-valvular atrial fibrillation patients taking dabigatran vs. warfarin using a large, nation-wide claims data in Japan.
Any patients with atrial fibrillation contained in the Medical Data Vision (MDVI) database which is a Japanese, nationwide claims data containing approximately 16 million patients cumulatively. The data cut is between March 2011 to June 2016, and the patients in the MDV database are those who have visited DPC hospitals (diagnostic procedure combination, a lump-sum payment system based on disease diagnosis to be treated similar to Medicare/Medicaid in the USA) hospitals which provide acute in-patient, as well as outpatient care.
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Exclusion Criteria:
patients with atrial fibrillation
Drug: Warfarin · Drug: Dabigatran
patients treated with warfarin
patients treated with Dabigatran
Also known as: PRADAXA
Incidence Rate of Stroke and Systemic Embolism (SE)
Incidence rate of stroke and systemic embolism (SE).
Time frame: 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 Major Bleeding
Incidence rate of major bleeding defined by any bleeding event associated with hospitalization claims and/or transfusion claims.
Time frame: 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.
A non-interventional study based on existing health insurance claims data. 5,146 and 13,115 patients were prescribed dabigatran and warfarin.
| Milestone | Dabigatran | Warfarin |
|---|---|---|
| Started | 5745 | 16745 |
| Completed | 5146 | 13115 |
| Not completed | 599 | 3630 |
| Withdrew: Not eligible patients | 599 | 3630 |
Incidence rate of stroke and systemic embolism (SE).
| per patient-year | Dabigatran | Warfarin |
|---|---|---|
| Incidence Rate of Stroke and Systemic Embolism (SE) | 2.898 | 3.563 |
Incidence rate of major bleeding defined by any bleeding event associated with hospitalization claims and/or transfusion claims.
| per patient-year | Dabigatran | Warfarin |
|---|---|---|
| Incidence Rate of Major Bleeding | 0.639 | 1.128 |
Non-serious events are listed at a 5% frequency threshold.
| Group | Deaths | Serious | Other |
|---|---|---|---|
| Dabigatran | — | — | — |
| Warfarin | — | — | — |
Eligible patients who were prescribed dabigatran and warfarin as the first OACs
| Age, Continuous(Years) | Dabigatran | Warfarin | Total |
|---|---|---|---|
| Mean | 72 ± 10 | 78 ± 10 | 76 ± 10 |
| Sex: Female, Male(Participants) | Dabigatran | Warfarin | Total |
|---|---|---|---|
| Female | 1695 | 5294 | 6989 |
| Male | 3451 | 7821 | 11272 |
| Race and Ethnicity Not Collected(Participants) | Dabigatran | Warfarin | Total |
|---|---|---|---|
| Count of participants | — | — | 0 |
PDFs hosted by the registry, ClinicalTrials.gov.
Plan to share: No
Ran from Oct 2017 to primary completion in Oct 2017, 0 months.
Results were first posted in Jul 2019, 1 year 8 months after primary completion.
How these figures are worked out, and which studies are left out of them.
This study is completed, as verified in Jul 2019. You cannot join it, but the record below documents what was studied.
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