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| Name | Class |
|---|---|
| Health ResearchTx, LLC (HRTX) | UNKNOWN |
| inVentiv Health Clinical (iVH) | UNKNOWN |
| United States Department of Defense | FED |
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The purpose of this study is to assess the safety and effectiveness of newly initiated dabigatran among patients diagnosed with non valvular atrial fibrillation (NVAF) in comparison to newly initiated rivaroxaban users and newly initiated apixaban users
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| Dabigatran vs. Rivaroxaban | OAC treatment naïve NVAF patients with at least one prescription claim for dabigatran, rivaroxaban (new oral anticoagulant or NOAC). |
| |
| Dabigatran vs. Apixaban | OAC treatment naïve NVAF patients with at least one prescription claim for dabigatran, or apixaban (new oral anticoagulant or NOAC). |
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| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| Dabigatran vs. Rivaroxaban | Drug | observed for 6 years |
| |
| Measure | Description | Time Frame |
|---|---|---|
| Stroke Overall (Hemorrhagic, Ischemic, Uncertain) | The event rate of overall stroke (hemorrhagic, ischemic, uncertain) in patients matched on propensity scores without index year. Event rates were calculated as the total number of patients in each treatment group who had the outcome during follow-up divided by the total person-years at risk in the cohort. Length of Follow-up: The post-index follow-up period began the day following the NOAC index date and ended on whichever of the following occurred earliest:
| Baseline (July 1, 2010) until end of the observation period (June 30, 2016), 6 Years |
| Overall Major Bleeding | The event rate of overall Major bleeding (Hemorrhagic Stroke, Major Intracranial Bleeding and Major Extracranial Bleeding) in patients matched on propensity scores without index year. Event rates were calculated as the total number of patients in each treatment group who had the outcome during follow-up divided by the total person-years at risk in the cohort. Follow-up time was the time elapsed from the index date to the date of the outcome of interest, disenrollment, end of the observation period (available data), death, discontinuation of the NOAC, or switch to a different NOAC, whichever came first. | Baseline (July 1, 2010) until end of the observation period (June 30, 2016), 6 Years |
| Measure | Description | Time Frame |
|---|---|---|
| Ischemic Stroke | The event rate of ischemic stroke in patients matched on propensity scores without index year. Event rates were calculated as the total number of patients in each treatment group who had the outcome during follow-up divided by the total person-years at risk in the cohort. Follow-up time was the time elapsed from the index date to the date of the outcome of interest, disenrollment, end of the observation period (available data), death, discontinuation of the NOAC, or switch to a different NOAC, whichever came first |
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Inclusion Criteria:
Exclusion Criteria:
Less than 12 months of continuous eligibility in the pre-index period Any claim for OAC drug (oral use only) in the pre-index period Diagnosis of hyperthyroidism during the pre-index period
Having at least one claim for alternative indications; orthopedic procedures, Venous thromboembolism (VTE) (includes deep vein thrombosis (DVT ) & PE)) and the index NOAC prescription at the same time, or, the alternative indication for anticoagulant occurring within 3 months prior to index date in pre-period Having at least one claim with any of the following diagnoses or procedure codes in order to exclude patients with "transient" causes of Afib (3 months prior to index date in pre-period):
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NVAF patients, ≥18 years of age, enrolled within the DoD Military Health System, who have newly initiated dabigatran, rivaroxaban, or apixaban. Patients must be treatment naïve from OAC use prior to first (index) NOAC.
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| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| Inventiv Health | Princeton | New Jersey | 08450 | United States |
The study was a US retrospective database of the Department of Defense (DoD) beneficiary population. Data was extracted from July 1, 2010 to June 30, 2016. Thus there was no pre-assignment/screening details.
This is a Non-interventional retrospective cohort study based on existing data with propensity score matching (PSM) in Non-valvular Atrial Fibrillation (NVAF) patients with new Non-Vitamin K antagonist oral anticoagulant (NOAC) use.
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| ID | Title | Description |
|---|---|---|
| FG000 | Dabigatran | Oral anticoagulant (OAC) treatment naïve NVAF patients with at least one Non-Vitamin K antagonist oral anticoagulant (NOAC) prescription claim for dabigatran . |
| FG001 | Rivaroxaban |
| Title | Milestones | Reasons Not Completed | |||||
|---|---|---|---|---|---|---|---|
| Overall Study |
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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 | Dec 15, 2016 |
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| Dabigatran vs. Apixaban |
| Drug |
Observed for 6 years |
|
| Baseline (July 1, 2010) until end of the observation period (June 30, 2016), 6 Years |
| Hemorrhagic Stroke | The event rate of Hemorrhagic stroke in patients matched on propensity scores without index year. Event rates were calculated as the total number of patients in each treatment group who had the outcome during follow-up divided by the total person-years at risk in the cohort. Follow-up time was the time elapsed from the index date to the date of the outcome of interest, disenrollment, end of the observation period (available data), death, discontinuation of the NOAC, or switch to a different NOAC, whichever came first. | Baseline (July 1, 2010) until end of the observation period (June 30, 2016), 6 Years |
| Major Intracranial Bleeding | The event rate of major intracranial bleeding in patients matched on propensity scores without index year. Event rates were calculated as the total number of patients in each treatment group who had the outcome during follow-up divided by the total person-years at risk in the cohort. Follow-up time was the time elapsed from the index date to the date of the outcome of interest, disenrollment, end of the observation period (available data), death, discontinuation of the NOAC, or switch to a different NOAC, whichever came first | Baseline (July 1, 2010) until end of the observation period (June 30, 2016), 6 Years |
| Major Extracranial Bleeding | The event rate of major extracranial bleeding (Major GI bleeding, Major urogenital bleeding and Major other bleeding) in patients matched on propensity scores without index year. Event rates were calculated as the total number of patients in each treatment group who had the outcome during follow-up divided by the total person-years at risk in the cohort. Follow-up time was the time elapsed from the index date to the date of the outcome of interest, disenrollment, end of the observation period (available data), death, discontinuation of the NOAC, or switch to a different NOAC, whichever came first | Baseline (July 1, 2010) until end of the observation period (June 30, 2016), 6 Years |
| Major GI Bleeding | The event rate of major GI bleeding (Upper GI Bleeding and Lower GI Bleeding) in patients matched on propensity scores without index year. Event rates were calculated as the total number of patients in each treatment group who had the outcome during follow-up divided by the total person-years at risk in the cohort. Follow-up time was the time elapsed from the index date to the date of the outcome of interest, disenrollment, end of the observation period (available data), death, discontinuation of the NOAC, or switch to a different NOAC, whichever came first | Baseline (July 1, 2010) until end of the observation period (June 30, 2016), 6 Years |
| Major Urogenital Bleeding | The event rate of major urogenital bleeding in patients matched on propensity scores without index year. Event rates were calculated as the total number of patients in each treatment group who had the outcome during follow-up divided by the total person-years at risk in the cohort. Follow-up time was the time elapsed from the index date to the date of the outcome of interest, disenrollment, end of the observation period (available data), death, discontinuation of the NOAC, or switch to a different NOAC, whichever came first. | Baseline (July 1, 2010) until end of the observation period (June 30, 2016), 6 Years |
| Major Other Bleeding | The event rate of major other bleeding in patients matched on propensity scores without index year. Event rates were calculated as the total number of patients in each treatment group who had the outcome during follow-up divided by the total person-years at risk in the cohort. Follow-up time was the time elapsed from the index date to the date of the outcome of interest, disenrollment, end of the observation period (available data), death, discontinuation of the NOAC, or switch to a different NOAC, whichever came first | Baseline (July 1, 2010) until end of the observation period (June 30, 2016), 6 Years |
| Upper GI Bleeding | The event rate of Upper GI Bleeding in patients matched on propensity scores without index year. Event rates were calculated as the total number of patients in each treatment group who had the outcome during follow-up divided by the total person-years at risk in the cohort. Follow-up time was the time elapsed from the index date to the date of the outcome of interest, disenrollment, end of the observation period (available data), death, discontinuation of the NOAC, or switch to a different NOAC, whichever came first | Baseline (July 1, 2010) until end of the observation period (June 30, 2016), 6 Years |
| Lower GI Bleeding | The event rate of Lower GI Bleeding in patients matched on propensity scores without index year. Event rates were calculated as the total number of patients in each treatment group who had the outcome during follow-up divided by the total person-years at risk in the cohort. Follow-up time was the time elapsed from the index date to the date of the outcome of interest, disenrollment, end of the observation period (available data), death, discontinuation of the NOAC, or switch to a different NOAC, whichever came first | Baseline (July 1, 2010) until end of the observation period (June 30, 2016), 6 Years |
| TIA | The event rate of transient ischemic attack (TIA) in patients matched on propensity scores without index year. Event rates were calculated as the total number of patients in each treatment group who had the outcome during follow-up divided by the total person-years at risk in the cohort. Follow-up time was the time elapsed from the index date to the date of the outcome of interest, disenrollment, end of the observation period (available data), death, discontinuation of the NOAC, or switch to a different NOAC, whichever came first | Baseline (July 1, 2010) until end of the observation period (June 30, 2016), 6 Years |
| All-cause Mortality | The event rate of all-cause mortality in patients matched on propensity scores without index year. Event rates were calculated as the total number of patients in each treatment group who had the outcome during follow-up divided by the total person-years at risk in the cohort. Follow-up time was the time elapsed from the index date to the date of the outcome of interest, disenrollment, end of the observation period (available data), death, discontinuation of the NOAC, or switch to a different NOAC, whichever came first | Baseline (July 1, 2010) until end of the observation period (June 30, 2016), 6 Years |
OAC treatment naïve NVAF patients with at least one NOAC prescription claim for rivaroxaban .
| FG002 | Apixaban | OAC treatment naïve NVAF patients with at least one NOAC prescription claim for apixaban . |
| COMPLETED |
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| NOT COMPLETED |
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The main analysis was on matched patients based on their baseline characteristics using the propensity score matching (PSM) for the two study cohorts (dabigatran vs rivaroxaban and dabigatran vs apixaban cohorts). Baseline measures were presented for overall treatment groups and matched populations.
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| ID | Title | Description |
|---|---|---|
| BG000 | Dabigatran | Oral anticoagulant (OAC) treatment naïve NVAF patients with at least one Non-Vitamin K antagonist oral anticoagulant (NOAC) prescription claim for dabigatran . |
| BG001 | Rivaroxaban | OAC treatment naïve NVAF patients with at least one NOAC prescription claim for rivaroxaban . |
| BG002 | Apixaban | OAC treatment naïve NVAF patients with at least one NOAC prescription claim for apixaban . |
| BG003 | Total | Total of all reporting groups |
| Units | Counts |
|---|---|
| Participants |
|
| Title | Description | Population Description | Parameter Type | Dispersion Type | Unit of Measure | Calculate Percentage | Denominator Units Selected | Denominators | Classes | |||||
|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|
| Age, Customized | The main analysis was on matched patients based on their baseline characteristics using the propensity score matching (PSM) for the two study cohorts (dabigatran vs rivaroxaban and dabigatran vs apixaban cohorts). Baseline measures were presented for overall treatment groups and matched populations. | Mean | Standard Deviation | Years |
| |||||||||
| Sex/Gender, Customized | The main analysis was on matched patients based on their baseline characteristics using the propensity score matching (PSM) for the two study cohorts (dabigatran vs rivaroxaban and dabigatran vs apixaban cohorts). Baseline measures were presented for overall treatment groups and matched populations. | Count of Participants | Participants |
| ||||||||||
| Race/Ethnicity, Customized | Ethnicity information was not collected for this trial. | The main analysis was on matched patients based on their baseline characteristics using the propensity score matching (PSM) for the two study cohorts (dabigatran vs rivaroxaban and dabigatran vs apixaban cohorts). Baseline measures were presented for overall treatment groups and matched populations. | Count of Participants | Participants |
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| 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 | |||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||
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| Primary | Stroke Overall (Hemorrhagic, Ischemic, Uncertain) | The event rate of overall stroke (hemorrhagic, ischemic, uncertain) in patients matched on propensity scores without index year. Event rates were calculated as the total number of patients in each treatment group who had the outcome during follow-up divided by the total person-years at risk in the cohort. Length of Follow-up: The post-index follow-up period began the day following the NOAC index date and ended on whichever of the following occurred earliest:
| Based on Department of Defense (DoD) outpatient prescription dispensed data the two separate study cohorts dabigatran vs rivaroxaban cohort and dabigatran vs apixaban cohort were formed. In both cohorts, dabigatran patients were matched 1:1 to comparator patients based on their baseline characteristics using the propensity score matching (PSM). | Posted | Number | 95% Confidence Interval | Event Rate in 100 person-years | Baseline (July 1, 2010) until end of the observation period (June 30, 2016), 6 Years |
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| Primary | Overall Major Bleeding | The event rate of overall Major bleeding (Hemorrhagic Stroke, Major Intracranial Bleeding and Major Extracranial Bleeding) in patients matched on propensity scores without index year. Event rates were calculated as the total number of patients in each treatment group who had the outcome during follow-up divided by the total person-years at risk in the cohort. Follow-up time was the time elapsed from the index date to the date of the outcome of interest, disenrollment, end of the observation period (available data), death, discontinuation of the NOAC, or switch to a different NOAC, whichever came first. | Based on Department of Defense (DoD) outpatient prescription dispensed data the two separate study cohorts dabigatran vs rivaroxaban cohort and dabigatran vs apixaban cohort were formed and matched 1: 1 based on their baseline characteristics using the propensity score matching (PSM). | Posted | Number | 95% Confidence Interval | Event Rate in 100 person-years | Baseline (July 1, 2010) until end of the observation period (June 30, 2016), 6 Years |
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| Secondary | Ischemic Stroke | The event rate of ischemic stroke in patients matched on propensity scores without index year. Event rates were calculated as the total number of patients in each treatment group who had the outcome during follow-up divided by the total person-years at risk in the cohort. Follow-up time was the time elapsed from the index date to the date of the outcome of interest, disenrollment, end of the observation period (available data), death, discontinuation of the NOAC, or switch to a different NOAC, whichever came first | Based on Department of Defense (DoD) outpatient prescription dispensed data the two separate study cohorts dabigatran vs rivaroxaban cohort and dabigatran vs apixaban cohort were formed and matched 1: 1 based on their baseline characteristics using the propensity score matching (PSM). | Posted | Number | 95% Confidence Interval | Event Rate in 100 person-years | Baseline (July 1, 2010) until end of the observation period (June 30, 2016), 6 Years |
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| Secondary | Hemorrhagic Stroke | The event rate of Hemorrhagic stroke in patients matched on propensity scores without index year. Event rates were calculated as the total number of patients in each treatment group who had the outcome during follow-up divided by the total person-years at risk in the cohort. Follow-up time was the time elapsed from the index date to the date of the outcome of interest, disenrollment, end of the observation period (available data), death, discontinuation of the NOAC, or switch to a different NOAC, whichever came first. | Based on Department of Defense (DoD) outpatient prescription dispensed data the two separate study cohorts dabigatran vs rivaroxaban cohort and dabigatran vs apixaban cohort were formed and matched 1: 1 based on their baseline characteristics using the propensity score matching (PSM). | Posted | Number | 95% Confidence Interval | Event Rate in 100 person-years | Baseline (July 1, 2010) until end of the observation period (June 30, 2016), 6 Years |
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| Secondary | Major Intracranial Bleeding | The event rate of major intracranial bleeding in patients matched on propensity scores without index year. Event rates were calculated as the total number of patients in each treatment group who had the outcome during follow-up divided by the total person-years at risk in the cohort. Follow-up time was the time elapsed from the index date to the date of the outcome of interest, disenrollment, end of the observation period (available data), death, discontinuation of the NOAC, or switch to a different NOAC, whichever came first | Based on Department of Defense (DoD) outpatient prescription dispensed data the two separate study cohorts dabigatran vs rivaroxaban cohort and dabigatran vs apixaban cohort were formed and matched 1: 1 based on their baseline characteristics using the propensity score matching (PSM). | Posted | Number | 95% Confidence Interval | Event Rate in 100 person-years | Baseline (July 1, 2010) until end of the observation period (June 30, 2016), 6 Years |
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| Secondary | Major Extracranial Bleeding | The event rate of major extracranial bleeding (Major GI bleeding, Major urogenital bleeding and Major other bleeding) in patients matched on propensity scores without index year. Event rates were calculated as the total number of patients in each treatment group who had the outcome during follow-up divided by the total person-years at risk in the cohort. Follow-up time was the time elapsed from the index date to the date of the outcome of interest, disenrollment, end of the observation period (available data), death, discontinuation of the NOAC, or switch to a different NOAC, whichever came first | Based on Department of Defense (DoD) outpatient prescription dispensed data the two separate study cohorts dabigatran vs rivaroxaban cohort and dabigatran vs apixaban cohort were formed and matched 1: 1 based on their baseline characteristics using the propensity score matching (PSM). | Posted | Number | 95% Confidence Interval | Event Rate in 100 person-years | Baseline (July 1, 2010) until end of the observation period (June 30, 2016), 6 Years |
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| Secondary | Major GI Bleeding | The event rate of major GI bleeding (Upper GI Bleeding and Lower GI Bleeding) in patients matched on propensity scores without index year. Event rates were calculated as the total number of patients in each treatment group who had the outcome during follow-up divided by the total person-years at risk in the cohort. Follow-up time was the time elapsed from the index date to the date of the outcome of interest, disenrollment, end of the observation period (available data), death, discontinuation of the NOAC, or switch to a different NOAC, whichever came first | Based on Department of Defense (DoD) outpatient prescription dispensed data the two separate study cohorts dabigatran vs rivaroxaban cohort and dabigatran vs apixaban cohort were formed and matched 1: 1 based on their baseline characteristics using the propensity score matching (PSM). | Posted | Number | 95% Confidence Interval | Event Rate in 100 person-years | Baseline (July 1, 2010) until end of the observation period (June 30, 2016), 6 Years |
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| Secondary | Major Urogenital Bleeding | The event rate of major urogenital bleeding in patients matched on propensity scores without index year. Event rates were calculated as the total number of patients in each treatment group who had the outcome during follow-up divided by the total person-years at risk in the cohort. Follow-up time was the time elapsed from the index date to the date of the outcome of interest, disenrollment, end of the observation period (available data), death, discontinuation of the NOAC, or switch to a different NOAC, whichever came first. | Based on Department of Defense (DoD) outpatient prescription dispensed data the two separate study cohorts dabigatran vs rivaroxaban cohort and dabigatran vs apixaban cohort were formed and matched 1: 1 based on their baseline characteristics using the propensity score matching (PSM). | Posted | Number | 95% Confidence Interval | Event Rate in 100 person-years | Baseline (July 1, 2010) until end of the observation period (June 30, 2016), 6 Years |
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| Secondary | Major Other Bleeding | The event rate of major other bleeding in patients matched on propensity scores without index year. Event rates were calculated as the total number of patients in each treatment group who had the outcome during follow-up divided by the total person-years at risk in the cohort. Follow-up time was the time elapsed from the index date to the date of the outcome of interest, disenrollment, end of the observation period (available data), death, discontinuation of the NOAC, or switch to a different NOAC, whichever came first | Based on Department of Defense (DoD) outpatient prescription dispensed data the two separate study cohorts dabigatran vs rivaroxaban cohort and dabigatran vs apixaban cohort were formed and matched 1: 1 based on their baseline characteristics using the propensity score matching (PSM). | Posted | Number | 95% Confidence Interval | Event Rate in 100 person-years | Baseline (July 1, 2010) until end of the observation period (June 30, 2016), 6 Years |
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| Secondary | Upper GI Bleeding | The event rate of Upper GI Bleeding in patients matched on propensity scores without index year. Event rates were calculated as the total number of patients in each treatment group who had the outcome during follow-up divided by the total person-years at risk in the cohort. Follow-up time was the time elapsed from the index date to the date of the outcome of interest, disenrollment, end of the observation period (available data), death, discontinuation of the NOAC, or switch to a different NOAC, whichever came first | Based on Department of Defense (DoD) outpatient prescription dispensed data the two separate study cohorts dabigatran vs rivaroxaban cohort and dabigatran vs apixaban cohort were formed and matched 1: 1 based on their baseline characteristics using the propensity score matching (PSM). | Posted | Number | 95% Confidence Interval | Event Rate in 100 person-years | Baseline (July 1, 2010) until end of the observation period (June 30, 2016), 6 Years |
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| Secondary | Lower GI Bleeding | The event rate of Lower GI Bleeding in patients matched on propensity scores without index year. Event rates were calculated as the total number of patients in each treatment group who had the outcome during follow-up divided by the total person-years at risk in the cohort. Follow-up time was the time elapsed from the index date to the date of the outcome of interest, disenrollment, end of the observation period (available data), death, discontinuation of the NOAC, or switch to a different NOAC, whichever came first | Based on Department of Defense (DoD) outpatient prescription dispensed data the two separate study cohorts dabigatran vs rivaroxaban cohort and dabigatran vs apixaban cohort were formed and matched 1: 1 based on their baseline characteristics using the propensity score matching (PSM). | Posted | Number | 95% Confidence Interval | Event Rate in 100 person-years | Baseline (July 1, 2010) until end of the observation period (June 30, 2016), 6 Years |
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| Secondary | TIA | The event rate of transient ischemic attack (TIA) in patients matched on propensity scores without index year. Event rates were calculated as the total number of patients in each treatment group who had the outcome during follow-up divided by the total person-years at risk in the cohort. Follow-up time was the time elapsed from the index date to the date of the outcome of interest, disenrollment, end of the observation period (available data), death, discontinuation of the NOAC, or switch to a different NOAC, whichever came first | Based on Department of Defense (DoD) outpatient prescription dispensed data the two separate study cohorts dabigatran vs rivaroxaban cohort and dabigatran vs apixaban cohort were formed and matched 1: 1 based on their baseline characteristics using the propensity score matching (PSM). | Posted | Number | 95% Confidence Interval | Event Rate in 100 person-years | Baseline (July 1, 2010) until end of the observation period (June 30, 2016), 6 Years |
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| Secondary | All-cause Mortality | The event rate of all-cause mortality in patients matched on propensity scores without index year. Event rates were calculated as the total number of patients in each treatment group who had the outcome during follow-up divided by the total person-years at risk in the cohort. Follow-up time was the time elapsed from the index date to the date of the outcome of interest, disenrollment, end of the observation period (available data), death, discontinuation of the NOAC, or switch to a different NOAC, whichever came first | Based on Department of Defense (DoD) outpatient prescription dispensed data the two separate study cohorts dabigatran vs rivaroxaban cohort and dabigatran vs apixaban cohort were formed and matched 1: 1 based on their baseline characteristics using the propensity score matching (PSM). | Posted | Number | 95% Confidence Interval | Event Rate in 100 person-years | Baseline (July 1, 2010) until end of the observation period (June 30, 2016), 6 Years |
|
Not provided
This is a retrospective observational study, in which all patient data were de-identified and analyzed in aggregate. Individual patient safety related information were not captured during this study. Thus, individual safety reporting (including adverse events reporting) was not applicable for this study.
Not provided
| 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 (OAC) treatment naïve NVAF patients with at least one Non-Vitamin K antagonist oral anticoagulant (NOAC) prescription claim for dabigatran. | 0 | 0 | 0 | 0 | 0 | 0 |
| EG001 | Rivaroxaban | OAC treatment naïve NVAF patients with at least one NOAC prescription claim for rivaroxaban. | 0 | 0 | 0 | 0 | 0 | 0 |
| EG002 | Apixaban | OAC treatment naïve NVAF patients with at least one NOAC prescription claim for apixaban. | 0 | 0 | 0 | 0 | 0 | 0 |
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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.
| Title | Organization | Phone | Extension | |
|---|---|---|---|---|
| Boehringer Ingelheim, Call Center | Boehringer Ingelheim | 1-800-243-0127 | clintriage.rdg@boehringer-ingelheim.com |
| Aug 16, 2018 |
| Prot_SAP_000.pdf |
| ID | Term |
|---|---|
| D001281 | Atrial Fibrillation |
| ID | Term |
|---|---|
| D001145 | Arrhythmias, Cardiac |
| D006331 | Heart Diseases |
| D002318 | Cardiovascular Diseases |
| D010335 | Pathologic Processes |
| D013568 | Pathological Conditions, Signs and Symptoms |
Not provided
Not provided
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| Dabigatran vs Rivaroxaban (matched pop) |
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| Dabigatran vs Apixaban (matched pop) |
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| Dabigatran vs Rivaroxaban (matched pop) |
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| Dabigatran vs Apixaban (matched pop) |
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| Dabigatran vs Rivaroxaban (matched pop) |
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| Dabigatran vs Apixaban (matched pop) |
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| Regression, Cox |
| 0.4892 |
| Hazard Ratio (HR) |
| 1.255 |
| 2-Sided |
| 95 |
| 0.659 |
| 2.390 |
| Other |
| OG002 | Dabigatran (Dabigatran vs Apixaban) | OAC treatment naïve NVAF patients with at least one NOAC prescription claim for dabigatran; 1:1 matching of dabigatran to apixaban was based on their baseline characteristics using the propensity score matching (PSM). |
| OG003 | Apixaban (Dabigatran vs Apixaban) | OAC treatment naïve NVAF patients with at least one NOAC prescription claim for apixaban; 1:1 matching of dabigatran to apixaban was based on their baseline characteristics using the propensity score matching (PSM). |
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| OG002 | Dabigatran (Dabigatran vs Apixaban) | OAC treatment naïve NVAF patients with at least one NOAC prescription claim for dabigatran; 1:1 matching of dabigatran to apixaban was based on their baseline characteristics using the propensity score matching (PSM). |
| OG003 | Apixaban (Dabigatran vs Apixaban) | OAC treatment naïve NVAF patients with at least one NOAC prescription claim for apixaban; 1:1 matching of dabigatran to apixaban was based on their baseline characteristics using the propensity score matching (PSM). |
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|
| OG002 | Dabigatran (Dabigatran vs Apixaban) | OAC treatment naïve NVAF patients with at least one NOAC prescription claim for dabigatran; 1:1 matching of dabigatran to apixaban was based on their baseline characteristics using the propensity score matching (PSM). |
| OG003 | Apixaban (Dabigatran vs Apixaban) | OAC treatment naïve NVAF patients with at least one NOAC prescription claim for apixaban; 1:1 matching of dabigatran to apixaban was based on their baseline characteristics using the propensity score matching (PSM). |
|
|
|
| OG002 | Dabigatran (Dabigatran vs Apixaban) | OAC treatment naïve NVAF patients with at least one NOAC prescription claim for dabigatran; 1:1 matching of dabigatran to apixaban was based on their baseline characteristics using the propensity score matching (PSM). |
| OG003 | Apixaban (Dabigatran vs Apixaban) | OAC treatment naïve NVAF patients with at least one NOAC prescription claim for apixaban; 1:1 matching of dabigatran to apixaban was based on their baseline characteristics using the propensity score matching (PSM). |
|
|
|
| OG002 | Dabigatran (Dabigatran vs Apixaban) | OAC treatment naïve NVAF patients with at least one NOAC prescription claim for dabigatran; 1:1 matching of dabigatran to apixaban was based on their baseline characteristics using the propensity score matching (PSM). |
| OG003 | Apixaban (Dabigatran vs Apixaban) | OAC treatment naïve NVAF patients with at least one NOAC prescription claim for apixaban; 1:1 matching of dabigatran to apixaban was based on their baseline characteristics using the propensity score matching (PSM). |
|
|
|
| OG002 | Dabigatran (Dabigatran vs Apixaban) | OAC treatment naïve NVAF patients with at least one NOAC prescription claim for dabigatran; 1:1 matching of dabigatran to apixaban was based on their baseline characteristics using the propensity score matching (PSM). |
| OG003 | Apixaban (Dabigatran vs Apixaban) | OAC treatment naïve NVAF patients with at least one NOAC prescription claim for apixaban; 1:1 matching of dabigatran to apixaban was based on their baseline characteristics using the propensity score matching (PSM). |
|
|
|
| OG002 | Dabigatran (Dabigatran vs Apixaban) | OAC treatment naïve NVAF patients with at least one NOAC prescription claim for dabigatran; 1:1 matching of dabigatran to apixaban was based on their baseline characteristics using the propensity score matching (PSM). |
| OG003 | Apixaban (Dabigatran vs Apixaban) | OAC treatment naïve NVAF patients with at least one NOAC prescription claim for apixaban; 1:1 matching of dabigatran to apixaban was based on their baseline characteristics using the propensity score matching (PSM). |
|
|
| OG002 | Dabigatran (Dabigatran vs Apixaban) | OAC treatment naïve NVAF patients with at least one NOAC prescription claim for dabigatran; 1:1 matching of dabigatran to apixaban was based on their baseline characteristics using the propensity score matching (PSM). |
| OG003 | Apixaban (Dabigatran vs Apixaban) | OAC treatment naïve NVAF patients with at least one NOAC prescription claim for apixaban; 1:1 matching of dabigatran to apixaban was based on their baseline characteristics using the propensity score matching (PSM). |
|
|
|
| OG002 | Dabigatran (Dabigatran vs Apixaban) | OAC treatment naïve NVAF patients with at least one NOAC prescription claim for dabigatran; 1:1 matching of dabigatran to apixaban was based on their baseline characteristics using the propensity score matching (PSM). |
| OG003 | Apixaban (Dabigatran vs Apixaban) | OAC treatment naïve NVAF patients with at least one NOAC prescription claim for apixaban; 1:1 matching of dabigatran to apixaban was based on their baseline characteristics using the propensity score matching (PSM). |
|
|
|
| OG002 | Dabigatran (Dabigatran vs Apixaban) | OAC treatment naïve NVAF patients with at least one NOAC prescription claim for dabigatran; 1:1 matching of dabigatran to apixaban was based on their baseline characteristics using the propensity score matching (PSM). |
| OG003 | Apixaban (Dabigatran vs Apixaban) | OAC treatment naïve NVAF patients with at least one NOAC prescription claim for apixaban; 1:1 matching of dabigatran to apixaban was based on their baseline characteristics using the propensity score matching (PSM). |
|
|
|
| OG002 | Dabigatran (Dabigatran vs Apixaban) | OAC treatment naïve NVAF patients with at least one NOAC prescription claim for dabigatran; 1:1 matching of dabigatran to apixaban was based on their baseline characteristics using the propensity score matching (PSM). |
| OG003 | Apixaban (Dabigatran vs Apixaban) | OAC treatment naïve NVAF patients with at least one NOAC prescription claim for apixaban; 1:1 matching of dabigatran to apixaban was based on their baseline characteristics using the propensity score matching (PSM). |
|
|
|
| OG002 | Dabigatran (Dabigatran vs Apixaban) | OAC treatment naïve NVAF patients with at least one NOAC prescription claim for dabigatran; 1:1 matching of dabigatran to apixaban was based on their baseline characteristics using the propensity score matching (PSM). |
| OG003 | Apixaban (Dabigatran vs Apixaban) | OAC treatment naïve NVAF patients with at least one NOAC prescription claim for apixaban; 1:1 matching of dabigatran to apixaban was based on their baseline characteristics using the propensity score matching (PSM). |
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| Other/Unknown/Missing |
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| Other/Unknown/Missing |
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