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 2019-03-04.
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 5th 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 53,969 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.
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This is a retrospective, observational, claims cohort study to assess, for adult patients initiating an oral anticoagulant for NVAF
This is a retrospective, observational, claims cohort study to assess, for adult patients initiating an oral anticoagulant for NVAF, the incidence rates of emergency surgery, major bleeding due to trauma, and major bleeding due to fracture, overall and stratified by age (\<64, 65-74, >75). The secondary objective is to estimate the overall and age stratified incidence of cardiac tamponade and peri-cardiocentesis.
Any patients with atrial fibrillation contained in the Medical Data Vision (MDV) 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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->18 year old non-valvular atrial fibrillation (NVAF) patients
Exclusion Criteria:
warfarin and non-vitamin K dependent oral anti-coagulants
Drug: warfarin · Drug: dabigatran · Drug: Apixaban · Drug: Edoxaban · Drug: Rivaroxaban
warfarin
Non-vitamin K dependent oral anti-coagulants (NOACs)
Also known as: PRADAXA, PRAZAXA
Non-vitamin K dependent oral anti-coagulants (NOACs)
Non-vitamin K dependent oral anti-coagulants (NOACs)
Non-vitamin K dependent oral anti-coagulants (NOACs)
The Number of Patients With Emergency Surgery and Major Bleeding Due to Fracture or Trauma.
The number of patients with emergency surgery and major bleeding due to fracture or trauma. Where emergency surgery defined as any surgical procedure (International Classification of Diseases (ICD) 10 code K000-879) performed on the same day as hospital admission with additional claims, major bleeding due to fracture is any bleeding associated with hospitalization or blood transfusion (ICD10 code E83.111) accompanied by any fracture, and major bleeding due to trauma is any bleeding associated with hospitalization or blood transfusion (ICD10 code E83.111) accompanied by any trauma.
Time frame: One year
The Number of Patients With Cardiac Tamponade and Pericardiocentesis.
The number of patients with cardiac tamponade and pericardiocentesis. Cardiac tamponade diagnosis (ICD 10 code 4200001) on the same or next day as catheter ablation or percutaneous coronary intervention (PCI), Pericardiocentesis (Medical Data Vision (MDV) procedure code 140010510) on the same or next day as catheter ablation or PCI.
Time frame: One year
Non-interventional study based on existing health insurance claims data
| Milestone | Patients Prescribed With Non-warfarin Oral Anti Coagulants |
|---|---|
| Started | 53969 |
| Completed | 53969 |
| Not completed | 0 |
The number of patients with emergency surgery and major bleeding due to fracture or trauma. Where emergency surgery defined as any surgical procedure (International Classification of Diseases (ICD) 10 code K000-879) performed on the same day as hospital admission with additional claims, major bleeding due to fracture is any bleeding associated with hospitalization or blood transfusion (ICD10 code E83.111) accompanied by any fracture, and major bleeding due to trauma is any bleeding associated with hospitalization or blood transfusion (ICD10 code E83.111) accompanied by any trauma.
| Number of Patients | Patients Prescribed With Non-warfarin Oral Anti Coagulants |
|---|---|
| Age <=64 | 14 |
| Age 65-74 | 35 |
| Age >=75 | 84 |
The number of patients with cardiac tamponade and pericardiocentesis. Cardiac tamponade diagnosis (ICD 10 code 4200001) on the same or next day as catheter ablation or percutaneous coronary intervention (PCI), Pericardiocentesis (Medical Data Vision (MDV) procedure code 140010510) on the same or next day as catheter ablation or PCI.
| Number of Patients | Patients Prescribed With Non-warfarin Oral Anti Coagulants |
|---|---|
| The Number of Patients With Cardiac Tamponade and Pericardiocentesis. | 1 |
Collected over No adverse event reporting was done.. Non-serious events are listed at a 5% frequency threshold.
| Group | Deaths | Serious | Other |
|---|---|---|---|
| Patients Prescribed With Non-warfarin Oral Anti Coagulants | — | — | — |
Baseline characteristics are based on the number of patients meeting the inclusion and exclusion criteria.
| Age, Continuous(Years) | Patients Prescribed With Non-warfarin Oral Anti Coagulants |
|---|---|
| Mean | 76 ± 10 |
| Sex: Female, Male(Participants) | Patients Prescribed With Non-warfarin Oral Anti Coagulants |
|---|---|
| Female | 21587 |
| Male | 32382 |
| Ethnicity (NIH/OMB)(Participants) | Patients Prescribed With Non-warfarin Oral Anti Coagulants |
|---|---|
| Hispanic or Latino | 0 |
| Not Hispanic or Latino | 53969 |
| Unknown or Not Reported | 0 |
| Race (NIH/OMB)(Participants) | Patients Prescribed With Non-warfarin Oral Anti Coagulants |
|---|---|
| American Indian or Alaska Native | 0 |
| Asian | 53969 |
| Native Hawaiian or Other Pacific Islander | 0 |
| Black or African American | 0 |
| White | 0 |
| More than one race | 0 |
| Unknown or Not Reported | 0 |
PDFs hosted by the registry, ClinicalTrials.gov.
Plan to share: Undecided
Ran from Oct 2017 to primary completion in Oct 2017, 0 months.
Results were first posted in Mar 2019, 1 year 4 months after primary completion.
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