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The objective is to assess the safety and effectiveness of new dabigatran and warfarin patients diagnosed with NVAF in the US DoD population.
Study Design:
Retrospective
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| Dabigatran | |||
| Warfarin |
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| Measure | Description | Time Frame |
|---|---|---|
| Stroke (Hemorrhagic, Ischemic) | Event rate of stroke (hemorrhagic, ischemic). Variables in the final propensity score model: age, gender index year, baseline CHADS(2) score (Congestive heart failure, Hypertension, Age ≥75 years, Diabetes mellitus, Prior Stroke or transient ischemic attack (TIA) or Thromboembolism), baseline CHA(2)DS(2)-VASc score (Congestive heart failure, Hypertension, Age ≥75 years (doubled), Diabetes mellitus, Stroke (doubled), Vascular disease, Age 65-74 years, Sex category), baseline HAS-BLED score (Hypertension, Abnormal renal/liver function, Stroke, Bleeding history or predisposition, Labile International Normalized Ratio, Elderly, Drugs/alcohol concomitantly), baseline use of several medications and presence of several baseline co-morbidities. The 12-month period prior to and including the index date was defined as the baseline period. Patients were required to have an NVAF diagnosis during this baseline period. | From October 1, 2009 through July 31, 2013 (the study period) |
| Major Bleeding | Event rate of major bleeding. The 12-month period prior to and including the index date was defined as the baseline period. Patients were required to have an NVAF diagnosis during this baseline period. | From October 1, 2009 through July 31, 2013 (the study period) |
| Measure | Description | Time Frame |
|---|---|---|
| Ischemic Stroke | Event rate of ischemic stroke. The 12-month period prior to and including the index date was defined as the baseline period. Patients were required to have an NVAF diagnosis during this baseline period. | From October 1, 2009 through July 31, 2013 (the study period) |
| Hemorrhagic Stroke |
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Inclusion criteria:
Exclusion criteria:
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NVAF
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| Name | Affiliation | Role |
|---|---|---|
| Boehringer Ingelheim | Boehringer Ingelheim | Study Chair |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| 1160.183.01 Boehringer Ingelheim Investigational Site | Lexington | Massachusetts | United States |
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Existing data cohort design with propensity score matching (PSM). Variables included in the final propensity score model were: age, gender index year, baseline CHADS(2) score, baseline CHA(2)DS(2)-VASc score, baseline HAS-BLED score, baseline use of several medications and presence of several baseline co-morbidities.
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| ID | Title | Description |
|---|---|---|
| FG000 | Dabigatran | Oral anticoagulant treatment-naive non-valvular atrial fibrillation (NVAF) patients aged 18-89 with their first prescription claim for dabigatran (either FDA-approved dose) during the study identification period (1 October 2010 and 31 July 2012). |
| FG001 | Warfarin | Oral anticoagulant treatment-naive non-valvular atrial fibrillation (NVAF) patients aged 18-89 with their first prescription claim for warfarin during the study identification period (1 October 2010 and 31 July 2012). |
| Title | Milestones | Reasons Not Completed | ||||||||||||
|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|
| Overall Study |
|
Post-PSM set
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| ID | Title | Description |
|---|---|---|
| BG000 | Dabigatran | Oral anticoagulant treatment-naive non-valvular atrial fibrillation (NVAF) patients aged 18-89 with their first prescription claim for dabigatran (either FDA-approved dose) during the study identification period (1 October 2010 and 31 July 2012). |
| BG001 | Warfarin |
| Units | Counts |
|---|---|
| Participants |
|
| Title | Description | Population Description | Parameter Type | Dispersion Type | Unit of Measure | Calculate Percentage | Denominator Units Selected | Denominators | Classes |
|---|---|---|---|---|---|---|---|---|---|
| Age, Continuous | Mean |
| 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 | Stroke (Hemorrhagic, Ischemic) | Event rate of stroke (hemorrhagic, ischemic). Variables in the final propensity score model: age, gender index year, baseline CHADS(2) score (Congestive heart failure, Hypertension, Age ≥75 years, Diabetes mellitus, Prior Stroke or transient ischemic attack (TIA) or Thromboembolism), baseline CHA(2)DS(2)-VASc score (Congestive heart failure, Hypertension, Age ≥75 years (doubled), Diabetes mellitus, Stroke (doubled), Vascular disease, Age 65-74 years, Sex category), baseline HAS-BLED score (Hypertension, Abnormal renal/liver function, Stroke, Bleeding history or predisposition, Labile International Normalized Ratio, Elderly, Drugs/alcohol concomitantly), baseline use of several medications and presence of several baseline co-morbidities. The 12-month period prior to and including the index date was defined as the baseline period. Patients were required to have an NVAF diagnosis during this baseline period. | All patients in the post-propensity score matching cohort | Posted | Number | 95% Confidence Interval | Events per 1000 person-years | From October 1, 2009 through July 31, 2013 (the study period) |
|
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This is a retrospective observational study, therefore all patient data was de-identified and analysed in aggregate. Thus, individual patient data is not available and reporting of adverse events is not applicable.
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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 | Oral anticoagulant treatment-naive non-valvular atrial fibrillation (NVAF) patients aged 18-89 with their first prescription claim for dabigatran (either FDA-approved dose) during the study identification period (1 October 2010 and 31 July 2012). |
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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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| ID | Term |
|---|---|
| D001281 | Atrial Fibrillation |
| ID | Term |
|---|---|
| D001145 | Arrhythmias, Cardiac |
| D006331 | Heart Diseases |
| D002318 | Cardiovascular Diseases |
| D010335 | Pathologic Processes |
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Event rate of hemorrhagic stroke. The 12-month period prior to and including the index date was defined as the baseline period. Patients were required to have an NVAF diagnosis during this baseline period. |
| From October 1, 2009 through July 31, 2013 (the study period). |
| Major Intracranial Bleeding | Event rate of major intracranial bleeding. The 12-month period prior to and including the index date was defined as the baseline period. Patients were required to have an NVAF diagnosis during this baseline period. | From October 1, 2009 through July 31, 2013 (the study period). |
| Major Extracranial Bleeding | Event rate of major extracranial bleeding. The 12-month period prior to and including the index date was defined as the baseline period. Patients were required to have an NVAF diagnosis during this baseline period. | From October 1, 2009 through July 31, 2013 (the study period). |
| Major GI Bleeding | Event rate of major gastrointestinal (GI) bleeding. The 12-month period prior to and including the index date was defined as the baseline period. Patients were required to have an NVAF diagnosis during this baseline period. | From October 1, 2009 through July 31, 2013 (the study period). |
| Major Upper GI Bleeding | Event rate of major upper gastrointestinal (GI) bleeding. The 12-month period prior to and including the index date was defined as the baseline period. Patients were required to have an NVAF diagnosis during this baseline period. | From October 1, 2009 through July 31, 2013 (the study period). |
| Major Lower GI Bleeding | Event rate of major lower gastrointestinal (GI) bleeding. The 12-month period prior to and including the index date was defined as the baseline period. Patients were required to have an NVAF diagnosis during this baseline period. | From October 1, 2009 through July 31, 2013 (the study period). |
| Major Urogenital Bleeding | Event rate of major urogenital bleeding. The 12-month period prior to and including the index date was defined as the baseline period. Patients were required to have an NVAF diagnosis during this baseline period. | From October 1, 2009 through July 31, 2013 (the study period). |
| Major Other Bleeding | Event rate of major other bleeding. The 12-month period prior to and including the index date was defined as the baseline period. Patients were required to have an NVAF diagnosis during this baseline period. | From October 1, 2009 through July 31, 2013 (the study period). |
| Transient Ischemic Attack | Event rate of transient ischemic attacks. The 12-month period prior to and including the index date was defined as the baseline period. Patients were required to have an NVAF diagnosis during this baseline period. | From October 1, 2009 through July 31, 2013 (the study period). |
| Myocardial Infarction | Event rate of myocardial infarction. The 12-month period prior to and including the index date was defined as the baseline period. Patients were required to have an NVAF diagnosis during this baseline period. | From October 1, 2009 through July 31, 2013 (the study period). |
| Venous Thromboembolism | Event rate of venous thromboembolism. The 12-month period prior to and including the index date was defined as the baseline period. Patients were required to have an NVAF diagnosis during this baseline period. | From October 1, 2009 through July 31, 2013 (the study period). |
| Deep Vein Thrombosis | Event rate of deep vein thrombosis. The 12-month period prior to and including the index date was defined as the baseline period. Patients were required to have an NVAF diagnosis during this baseline period. | From October 1, 2009 through July 31, 2013 (the study period). |
| Pulmonary Embolism | Event rate of pulmonary embolism. The 12-month period prior to and including the index date was defined as the baseline period. Patients were required to have an NVAF diagnosis during this baseline period. | From October 1, 2009 through July 31, 2013 (the study period). |
| Death | Event rate of death, due to any cause. The 12-month period prior to and including the index date was defined as the baseline period. Patients were required to have an NVAF diagnosis during this baseline period. | From October 1, 2009 through July 31, 2013 (the study period). |
Oral anticoagulant treatment-naive non-valvular atrial fibrillation (NVAF) patients aged 18-89 with their first prescription claim for warfarin during the study identification period (1 October 2010 and 31 July 2012). |
| BG002 | Total | Total of all reporting groups |
| years |
|
| Sex: Female, Male | Count of Participants | Participants |
|
| Description |
|---|
| OG000 | Dabigatran | Oral anticoagulant treatment-naive non-valvular atrial fibrillation (NVAF) patients aged 18-89 with their first prescription claim for dabigatran (either FDA-approved dose) during the study identification period (1 October 2010 and 31 July 2012). |
| OG001 | Warfarin | Oral anticoagulant treatment-naive non-valvular atrial fibrillation (NVAF) patients aged 18-89 with their first prescription claim for warfarin during the study identification period (1 October 2010 and 31 July 2012). |
|
|
|
| Primary | Major Bleeding | Event rate of major bleeding. The 12-month period prior to and including the index date was defined as the baseline period. Patients were required to have an NVAF diagnosis during this baseline period. | All patients in the post-propensity score matching cohort | Posted | Number | 95% Confidence Interval | Events per 1000 person-years | From October 1, 2009 through July 31, 2013 (the study period) |
|
|
|
|
| Secondary | Ischemic Stroke | Event rate of ischemic stroke. The 12-month period prior to and including the index date was defined as the baseline period. Patients were required to have an NVAF diagnosis during this baseline period. | All patients in the post-propensity score matching cohort | Posted | Number | 95% Confidence Interval | Events per 1000 person-years | From October 1, 2009 through July 31, 2013 (the study period) |
|
|
|
|
| Secondary | Hemorrhagic Stroke | Event rate of hemorrhagic stroke. The 12-month period prior to and including the index date was defined as the baseline period. Patients were required to have an NVAF diagnosis during this baseline period. | All patients in the post-propensity score matching cohort | Posted | Number | 95% Confidence Interval | Events per 1000 person-years | From October 1, 2009 through July 31, 2013 (the study period). |
|
|
|
|
| Secondary | Major Intracranial Bleeding | Event rate of major intracranial bleeding. The 12-month period prior to and including the index date was defined as the baseline period. Patients were required to have an NVAF diagnosis during this baseline period. | All patients in the post-propensity score matching cohort | Posted | Number | 95% Confidence Interval | Events per 1000 person-years | From October 1, 2009 through July 31, 2013 (the study period). |
|
|
|
|
| Secondary | Major Extracranial Bleeding | Event rate of major extracranial bleeding. The 12-month period prior to and including the index date was defined as the baseline period. Patients were required to have an NVAF diagnosis during this baseline period. | All patients in the post-propensity score matching cohort | Posted | Number | 95% Confidence Interval | Events per 1000 person-years | From October 1, 2009 through July 31, 2013 (the study period). |
|
|
|
|
| Secondary | Major GI Bleeding | Event rate of major gastrointestinal (GI) bleeding. The 12-month period prior to and including the index date was defined as the baseline period. Patients were required to have an NVAF diagnosis during this baseline period. | All patients in the post-propensity score matching cohort | Posted | Number | 95% Confidence Interval | Events per 1000 person-years | From October 1, 2009 through July 31, 2013 (the study period). |
|
|
|
|
| Secondary | Major Upper GI Bleeding | Event rate of major upper gastrointestinal (GI) bleeding. The 12-month period prior to and including the index date was defined as the baseline period. Patients were required to have an NVAF diagnosis during this baseline period. | All patients in the post-propensity score matching cohort | Posted | Number | 95% Confidence Interval | Events per 1000 person-years | From October 1, 2009 through July 31, 2013 (the study period). |
|
|
|
|
| Secondary | Major Lower GI Bleeding | Event rate of major lower gastrointestinal (GI) bleeding. The 12-month period prior to and including the index date was defined as the baseline period. Patients were required to have an NVAF diagnosis during this baseline period. | All patients in the post-propensity score matching cohort | Posted | Number | 95% Confidence Interval | Events per 1000 person-years | From October 1, 2009 through July 31, 2013 (the study period). |
|
|
|
|
| Secondary | Major Urogenital Bleeding | Event rate of major urogenital bleeding. The 12-month period prior to and including the index date was defined as the baseline period. Patients were required to have an NVAF diagnosis during this baseline period. | All patients in the post-propensity score matching cohort | Posted | Number | 95% Confidence Interval | Events per 1000 person-years | From October 1, 2009 through July 31, 2013 (the study period). |
|
|
|
|
| Secondary | Major Other Bleeding | Event rate of major other bleeding. The 12-month period prior to and including the index date was defined as the baseline period. Patients were required to have an NVAF diagnosis during this baseline period. | All patients in the post-propensity score matching cohort | Posted | Number | 95% Confidence Interval | Events per 1000 person-years | From October 1, 2009 through July 31, 2013 (the study period). |
|
|
|
|
| Secondary | Transient Ischemic Attack | Event rate of transient ischemic attacks. The 12-month period prior to and including the index date was defined as the baseline period. Patients were required to have an NVAF diagnosis during this baseline period. | All patients in the post-propensity score matching cohort | Posted | Number | 95% Confidence Interval | Events per 1000 person-years | From October 1, 2009 through July 31, 2013 (the study period). |
|
|
|
|
| Secondary | Myocardial Infarction | Event rate of myocardial infarction. The 12-month period prior to and including the index date was defined as the baseline period. Patients were required to have an NVAF diagnosis during this baseline period. | All patients in the post-propensity score matching cohort | Posted | Number | 95% Confidence Interval | Events per 1000 person-years | From October 1, 2009 through July 31, 2013 (the study period). |
|
|
|
|
| Secondary | Venous Thromboembolism | Event rate of venous thromboembolism. The 12-month period prior to and including the index date was defined as the baseline period. Patients were required to have an NVAF diagnosis during this baseline period. | All patients in the post-propensity score matching cohort | Posted | Number | 95% Confidence Interval | Events per 1000 person-years | From October 1, 2009 through July 31, 2013 (the study period). |
|
|
|
|
| Secondary | Deep Vein Thrombosis | Event rate of deep vein thrombosis. The 12-month period prior to and including the index date was defined as the baseline period. Patients were required to have an NVAF diagnosis during this baseline period. | All patients in the post-propensity score matching cohort | Posted | Number | 95% Confidence Interval | Events per 1000 person-years | From October 1, 2009 through July 31, 2013 (the study period). |
|
|
|
|
| Secondary | Pulmonary Embolism | Event rate of pulmonary embolism. The 12-month period prior to and including the index date was defined as the baseline period. Patients were required to have an NVAF diagnosis during this baseline period. | All patients in the post-propensity score matching cohort | Posted | Number | 95% Confidence Interval | Events per 1000 person-years | From October 1, 2009 through July 31, 2013 (the study period). |
|
|
|
|
| Secondary | Death | Event rate of death, due to any cause. The 12-month period prior to and including the index date was defined as the baseline period. Patients were required to have an NVAF diagnosis during this baseline period. | All patients in the post-propensity score matching cohort | Posted | Number | 95% Confidence Interval | Events per 1000 person-years | From October 1, 2009 through July 31, 2013 (the study period). |
|
|
|
|
| 0 |
| 0 |
| 0 |
| 0 |
| EG001 | Warfarin | Oral anticoagulant treatment-naive non-valvular atrial fibrillation (NVAF) patients aged 18-89 with their first prescription claim for warfarin during the study identification period (1 October 2010 and 31 July 2012). | 0 | 0 | 0 | 0 |
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 |