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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.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| Atrial Fibrillation | patients with atrial fibrillation |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| Warfarin | Drug | patients treated with warfarin |
| |
| Dabigatran |
| Measure | Description | Time Frame |
|---|---|---|
| Incidence Rate of Stroke and Systemic Embolism (SE) | 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. |
| Measure | Description | Time Frame |
|---|---|---|
| Incidence Rate of Major Bleeding | Incidence rate of major bleeding defined by any bleeding event associated with hospitalization claims and/or transfusion claims. | 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. |
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Inclusion Criteria:
Exclusion Criteria:
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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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| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| Nippon Boehringer Ingelheim Co., Ltd. | Tokyo | Japan |
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The Japanese patients diagnosed as Non-Valvular Atrial Fibrillation (NVAF) and newly treated with dabigatran and warfarin in the real world Japanese setting between April 2010 and June 2016 using the Medical Data Vision (MDV) database.
A non-interventional study based on existing health insurance claims data. 5,146 and 13,115 patients were prescribed dabigatran and warfarin.
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| ID | Title | Description |
|---|---|---|
| FG000 | Dabigatran | Patients prescribed dabigatran as the first Oral Anticoagulants (OACs) with nonvalvular atrial fibrillation. |
| FG001 | Warfarin | Patients prescribed warfarin as the first Oral Anticoagulants (OACs) with nonvalvular atrial fibrillation. |
| Title | Milestones | Reasons Not Completed | ||||||||||||||||||
|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|
| Overall Study |
|
|
Eligible patients who were prescribed dabigatran and warfarin as the first OACs
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| ID | Title | Description |
|---|---|---|
| BG000 | Dabigatran | Patients prescribed dabigatran as the first Oral Anticoagulants (OACs) with nonvalvular atrial fibrillation. |
| BG001 | Warfarin | Patients prescribed warfarin as the first Oral Anticoagulants (OACs) with nonvalvular atrial fibrillation. |
| Units | Counts |
|---|---|
| Participants |
|
| Title | Description | Population Description | Parameter Type | Dispersion Type | Unit of Measure | Calculate Percentage | Denominator Units Selected | Denominators | Classes |
|---|---|---|---|---|---|---|---|---|---|
| Age, Continuous | Eligible patients who were prescribed dabigatran and warfarin as the first OACs |
| 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 | Incidence Rate of Stroke and Systemic Embolism (SE) | Incidence rate of stroke and systemic embolism (SE). | Eligible patient who were prescribed dabigatran and warfarin as the first OACs and matched 1: 1 using the propensity score matching (PSM). | Posted | Number | per patient-year | 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. |
|
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This is a cohort study using based on existing data; therefore, it is not feasible to make a causality assessment at the individual case level.
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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 | Dabigatran | Patients prescribed dabigatran as the first Oral Anticoagulants (OACs) with nonvalvular atrial fibrillation. |
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| 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 6, 2017 | Oct 22, 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 |
| ID | Term |
|---|---|
| D015110 | 4-Hydroxycoumarins |
| D003374 | Coumarins |
| D001578 | Benzopyrans |
| D011714 | Pyrans |
| D006573 |
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| Drug |
patients treated with Dabigatran |
|
|
| BG002 | Total | Total of all reporting groups |
| Mean |
| Standard Deviation |
| Years |
|
| Sex: Female, Male | Eligible patients who were prescribed dabigatran and warfarin as the first OACs | Count of Participants | Participants |
|
| Race and Ethnicity Not Collected | Race and Ethnicity were not collected from any participant. | Count of Participants | Participants |
|
Patients prescribed warfarin as the first Oral Anticoagulants (OACs) with nonvalvular atrial fibrillation.
|
|
|
| Secondary | Incidence Rate of Major Bleeding | Incidence rate of major bleeding defined by any bleeding event associated with hospitalization claims and/or transfusion claims. | Eligible patient who were prescribed dabigatran and warfarin as the first OACs and matched 1: 1 using the propensity score matching (PSM). | Posted | Number | per patient-year | 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. |
|
|
|
|
| 0 |
| 0 |
| 0 |
| 0 |
| 0 |
| 0 |
| EG001 | Warfarin | Patients prescribed warfarin as the first Oral Anticoagulants (OACs) with nonvalvular atrial fibrillation. | 0 | 0 | 0 | 0 | 0 | 0 |
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| 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 |