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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.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| patients prescribed with Oral Anti-coagulants | warfarin and non-vitamin K dependent oral anti-coagulants |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| warfarin | Drug | warfarin |
| |
| Measure | Description | Time Frame |
|---|---|---|
| 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. | One year |
| Measure | Description | Time Frame |
|---|---|---|
| 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. |
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Inclusion Criteria:
->18 year old non-valvular atrial fibrillation (NVAF) patients
Exclusion Criteria:
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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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| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| Nippon Boehringer Ingelheim Co., Ltd. | Tokyo | Japan |
| PubMed Identifier | Type | Citation | Retractions |
|---|---|---|---|
| 32394292 | Derived | Yasaka M, Yokota H, Suzuki M, Yamane T, Ono Y. Incidence Rates of Bleeding and Emergency Surgery Due to Trauma or Fracture Among Japanese Patients with Non-valvular Atrial Fibrillation Receiving Oral Anticoagulation Therapy. Cardiol Ther. 2020 Jun;9(1):189-199. doi: 10.1007/s40119-020-00171-w. Epub 2020 May 11. |
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All patients were screened for eligibility to participate in the trial. Patients met all strictly implemented inclusion/exclusion criteria. Patients were not to be entered to trial if any one of the specific entry criteria was violated.
Non-interventional study based on existing health insurance claims data
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| ID | Title | Description |
|---|---|---|
| FG000 | Patients Prescribed With Non-warfarin Oral Anti Coagulants | Patients prescribed with Non-warfarin Oral Anti Coagulants (NOACs) (dabigatran, rivaroxaban, apixaban, edoxaban) or warfarin were grouped as a single exposure group and analysed as a whole. On treatment duration was expressed in patient year for the follow-up duration to calculate the incidence of various clinical events during the on-treatment duration. |
| Title | Milestones | Reasons Not Completed | ||||||||||||
|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|
| Overall Study |
|
Baseline characteristics are based on the number of patients meeting the inclusion and exclusion criteria.
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| ID | Title | Description |
|---|---|---|
| BG000 | Patients Prescribed With Non-warfarin Oral Anti Coagulants | Patients prescribed with Non-warfarin Oral Anti Coagulants (NOACs) (dabigatran, rivaroxaban, apixaban, edoxaban) or warfarin were grouped as a single exposure group and analysed as a whole. On treatment duration was expressed in patient year for the follow-up duration to calculate the incidence of various clinical events during the on-treatment duration. |
| Units | Counts |
|---|---|
| Participants |
|
| Title | Description | Population Description | Parameter Type | Dispersion Type | Unit of Measure | Calculate Percentage | Denominator Units Selected | Denominators | Classes |
|---|---|---|---|---|---|---|---|---|---|
| Age, Continuous | Baseline characteristics are based on the number of patients meeting the inclusion and exclusion criteria. |
| Type | Title | Description | Population Description | Reporting Status | Anticipated Posting Date | Parameter Type | Dispersion Type | Unit of Measure | Calculate Percentage | Time Frame | Units Analyzed | Denominator Units Selected | Arm/Group Information | Denominators | Classes | Analyses | |||
|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|
| Primary | 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. | Results are based on the number of patients meeting the inclusion and exclusion criteria. | Posted | Number | Number of Patients | One year |
|
No adverse event reporting was done.
This is a cohort study based on existing data; therefore, it is not feasible to make a causality assessment at the individual case level. Hence no adverse event reporting was done.
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| ID | Title | Description | Deaths (Affected) | Deaths (At Risk) | Serious Events (Affected) | Serious Events (At Risk) | Other Events (Affected) | Other Events (At Risk) |
|---|---|---|---|---|---|---|---|---|
| EG000 | Patients Prescribed With Non-warfarin Oral Anti Coagulants | Patients prescribed with Non-warfarin Oral Anti Coagulants (NOACs) (dabigatran, rivaroxaban, apixaban, edoxaban) or warfarin were grouped as a single exposure group and analysed as a whole. On treatment duration was expressed in patient year for the follow-up duration to calculate the incidence of various clinical events during the on-treatment duration. |
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The findings from this study may not be generalizable to other Japanese population outside of Diagnosis Procedure Combination (DPC) hospitals. All information of each patient is from consent giving DPC hospitals.
| Title | Organization | Phone | Extension | |
|---|---|---|---|---|
| Boehringer Ingelheim, Call Center | Boehringer Ingelheim | 1-800-243-0127 | clintriage.rdg@boehringer-ingelheim.com |
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| Type | Includes Protocol | Includes SAP | Includes ICF | Document Label | Document Date | Document Uploaded Date | Document File Name |
|---|---|---|---|---|---|---|---|
| Prot_SAP | Yes | Yes | No | Study Protocol and Statistical Analysis Plan | Jul 18, 2017 | Oct 30, 2018 | Prot_SAP_000.pdf |
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| ID | Term |
|---|---|
| D001281 | Atrial Fibrillation |
| ID | Term |
|---|---|
| D001145 | Arrhythmias, Cardiac |
| D006331 | Heart Diseases |
| D002318 | Cardiovascular Diseases |
| D010335 | Pathologic Processes |
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| ID | Term |
|---|---|
| D014859 | Warfarin |
| D000069604 | Dabigatran |
| C522181 | apixaban |
| C552171 | edoxaban |
| D000069552 | Rivaroxaban |
| ID | Term |
|---|---|
| D015110 | 4-Hydroxycoumarins |
| D003374 | Coumarins |
| D001578 | Benzopyrans |
| D011714 | Pyrans |
| D006573 |
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| dabigatran |
| Drug |
Non-vitamin K dependent oral anti-coagulants (NOACs) |
|
|
| Apixaban | Drug | Non-vitamin K dependent oral anti-coagulants (NOACs) |
|
| Edoxaban | Drug | Non-vitamin K dependent oral anti-coagulants (NOACs) |
|
| Rivaroxaban | Drug | Non-vitamin K dependent oral anti-coagulants (NOACs) |
|
| One year |
| Mean |
| Standard Deviation |
| Years |
|
| Sex: Female, Male | Baseline characteristics are based on the number of patients meeting the inclusion and exclusion criteria. | Count of Participants | Participants |
|
| Ethnicity (NIH/OMB) | Baseline characteristics are based on the number of patients meeting the inclusion and exclusion criteria. | Count of Participants | Participants |
|
| Race (NIH/OMB) | Baseline characteristics are based on the number of patients meeting the inclusion and exclusion criteria. | Count of Participants | Participants |
|
Patients prescribed with Non-warfarin Oral Anti Coagulants (NOACs) (dabigatran, rivaroxaban, apixaban, edoxaban) or warfarin were grouped as a single exposure group and analysed as a whole. On treatment duration was expressed in patient year for the follow-up duration to calculate the incidence of various clinical events during the on-treatment duration.
|
|
| Secondary | 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. | Results are based on the number of patients meeting the inclusion and exclusion criteria. | Posted | Number | Number of Patients | One year |
|
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Boehringer Ingelheim (BI) acknowledges that investigators have the right to publish the study results. Investigators shall provide BI with a copy of any publication or presentation for review prior to any submission. Such review will be done with regard to proprietary information, information related to patentable inventions, medical, scientific, and statistical accuracy within 60 days. BI may request a delay of the publication in order to protect BI's intellectual property rights.
| D013568 |
| Pathological Conditions, Signs and Symptoms |
| Heterocyclic Compounds, 1-Ring |
| D006571 | Heterocyclic Compounds |
| D006574 | Heterocyclic Compounds, 2-Ring |
| D000072471 | Heterocyclic Compounds, Fused-Ring |
| D011725 | Pyridines |
| D001562 | Benzimidazoles |
| D013876 | Thiophenes |
| D013457 | Sulfur Compounds |
| D009930 | Organic Chemicals |
| D009025 | Morpholines |
| D010078 | Oxazines |