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This study plans to describe utilization patterns for oral anticoagulants over time in patients with non-valvular atrial fibrillation at risk for stroke using electronic claims data from a United States commercial insurance database.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| Dabigatran | |||
| Warfarin or other New Oral Anticoagulant (NOAC) |
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| Measure | Description | Time Frame |
|---|---|---|
| Description of the Characteristics of Anticoagulant Initiators | The analyses described the characteristics of patients treated with various oral anticoagulants. CHA2DS2-VASc stroke risk score is calculated based on the following conditions: Congestive heart failure/ Left ventricular (LV) dysfunction, Hypertension, Age (≥ 75), Diabetes Mellitus, Stroke/ transient ischemic attack (TIA) /thromboembolism, Vascular disease, Age 65-74, female gender. HAS-BLED bleeding risk score is calculated based on the following conditions: Hypertension, Abnormal renal and liver function, Stroke (1 point), Bleeding history or predisposition, Labile international normalized ratio (INR), Elderly (>65 years), Drugs and Alcohol. CHA2DS2-VASc stroke risk score may range from 0 to 9 with 0 being the best outcome. HAS-BLED bleeding risk score may range from 0 to 9 with 0 being the best outcome. New initiators of warfarin before Dabigatran became available were only characterized in terms of age and sex (results provided above). | From January 2009 to September 2015 (The study period) |
| Percentage of Patients Initiating Specific Anticoagulant | Proportion of patients initiating specific anticoagulant over time per arm in source cohort is estimated and is expressed in percentage. This is related to UnitedHealth database and no treatment initiation rate was estimated in MarketScan as the study cohort was defined from a population of oral anticoagulants users. The overall number of participants analyzed "609201" reported for each of the treatment arm below corresponds to overall patients numbers in UnitedHealth for the entire study period rather than for each of the treatment arm. Likewise the number of participants for each of the treatment arm for different time period corresponds to the total number of participants for the specific study period rather than for each of the treatment arm. Incident users at given time period could also be counted in later time period if the patient discontinued the drug and had re-entry during the study period. | From January 2009 to September 2015 (The study period) |
| Percentage of Patients Initiating Specific Anticoagulant Dose - Dabigatran | Percentage of patients initiating specific anticoagulant dose of dabigatran across all time periods combined in the unmatched cohort for UnitedHealth and MarketScan cohort are presented. Proportion of patients initiating specific anticoagulant over time per arm in source cohort is estimated and is expressed in percentage. |
| Measure | Description | Time Frame |
|---|---|---|
| Treatment Persistence Over Time | Overall treatment persistence in UnitedHealth and MarketScan cohorts are presented as the percentage of patients who were persistent to treatment after 3, 6 and 12 months of follow-up for all time periods combined and matched cohort. Based on two US-based longitudinal healthcare claims databases (MarketScan and unitedHealth Research Database) the three separate study cohorts warfarin vs dabigatran, warfarin vs rivaroxaban and warfarin vs apixaban cohort were formed for each database. |
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Inclusion criteria:
Exclusion criteria:
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Patients 18 years of age and older with non-valvular AF at risk for stroke treated with oral anticoagulation
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| Name | Affiliation | Role |
|---|---|---|
| Boehringer Ingelheim | Boehringer Ingelheim | Study Chair |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| Brigham and Women's Hospital | Boston | Massachusetts | 02120 | United States |
The data source for this project was a combination of claims data from UnitedHealth, a commercial health insurer, and MarketScan, a research claims database from commercial employer-sponsored health plans both of which provide comprehensive medical coverage for members with active policies.
This study used a cohort design with descriptive analyses, using data from January 2009 through September 2015. The study was conducted within two US-based longitudinal healthcare claims databases (MarketScan and UnitedHealth Research Database).
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| ID | Title | Description |
|---|---|---|
| FG000 | Cohort UnitedHealth Dabigatran Users | Patients with a diagnosis of non-valvular atrial fibrillation (NVAF) new initiators of Dabigatran who were enrolled for a minimum of 12 months in UnitedHealth cohort before treatment initiation. |
| FG001 | Cohort UnitedHealth Rivaroxaban Users | Patients with a diagnosis of non-valvular atrial fibrillation (NVAF) new initiators of Rivaroxaban who were enrolled for a minimum of 12 months in UnitedHealth cohort before treatment initiation. |
| FG002 | Cohort UnitedHealth Apixaban Users | Patients with a diagnosis of non-valvular atrial fibrillation (NVAF) new initiators of Apixaban who were enrolled for a minimum of 12 months in UnitedHealth cohort before treatment initiation. |
| FG003 | Cohort UnitedHealth WarfarinUsers (After Dabigatran Available) | Patients with a diagnosis of non-valvular atrial fibrillation (NVAF) new initiators of Warfarin after Dabigatran became available who were enrolled for a minimum of 12 months in UnitedHealth cohort before treatment initiation. |
| FG004 | Cohort UnitedHealth WarfarinUsers(Before Dabigatran Available) | Patients with a diagnosis of non-valvular atrial fibrillation (NVAF) new initiators of Warfarin before Dabigatran became available who were enrolled for a minimum of 12 months in UnitedHealth cohort before treatment initiation. |
| FG005 | Cohort MarketScan Dabigatran Users | Patients with a diagnosis of non-valvular atrial fibrillation (NVAF) new initiators of Dabigatran who were enrolled for a minimum of 12 months in MarketScan cohort before treatment initiation. |
| FG006 | Cohort MarketScan Rivaroxaban Users | Patients with a diagnosis of non-valvular atrial fibrillation (NVAF) new initiators of Rivaroxaban who were enrolled for a minimum of 12 months in MarketScan cohort before treatment initiation. |
| FG007 | Cohort MarketScan Apixaban Users | Patients with a diagnosis of non-valvular atrial fibrillation (NVAF) new initiators of Apixaban who were enrolled for a minimum of 12 months in MarketScan cohort before treatment initiation. |
| FG008 | Cohort MarketScan WarfarinUsers (After Dabigatran Available) | Patients with a diagnosis of non-valvular atrial fibrillation (NVAF) new initiators of Warfarin after Dabigatran became available who were enrolled for a minimum of 12 months in MarketScan cohort before treatment initiation. |
| FG009 | Cohort MarketScan WarfarinUsers(Before Dabigatran Available) | Patients with a diagnosis of non-valvular atrial fibrillation (NVAF) new initiators of Warfarin before Dabigatran became available who were enrolled for a minimum of 12 months in MarketScan cohort before treatment initiation. |
| Title | Milestones | Reasons Not Completed | ||||||||||||
|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|
| Overall Study |
|
All patients with nonvalvular atrial fibrillation at risk for stroke initiating oral anticoagulants and a description of existing utilization patterns for warfarin and for the new oral anticoagulant (NOAC) medications as they become available over time.
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| ID | Title | Description |
|---|---|---|
| BG000 | Cohort UnitedHealth Dabigatran Users | Patients with a diagnosis of non-valvular atrial fibrillation (NVAF) new initiators of Dabigatran who were enrolled for a minimum of 12 months in UnitedHealth cohort before treatment initiation. |
| BG001 | Cohort UnitedHealth Rivaroxaban Users |
| 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 | Description of the Characteristics of Anticoagulant Initiators | The analyses described the characteristics of patients treated with various oral anticoagulants. CHA2DS2-VASc stroke risk score is calculated based on the following conditions: Congestive heart failure/ Left ventricular (LV) dysfunction, Hypertension, Age (≥ 75), Diabetes Mellitus, Stroke/ transient ischemic attack (TIA) /thromboembolism, Vascular disease, Age 65-74, female gender. HAS-BLED bleeding risk score is calculated based on the following conditions: Hypertension, Abnormal renal and liver function, Stroke (1 point), Bleeding history or predisposition, Labile international normalized ratio (INR), Elderly (>65 years), Drugs and Alcohol. CHA2DS2-VASc stroke risk score may range from 0 to 9 with 0 being the best outcome. HAS-BLED bleeding risk score may range from 0 to 9 with 0 being the best outcome. New initiators of warfarin before Dabigatran became available were only characterized in terms of age and sex (results provided above). | All patients with nonvalvular atrial fibrillation at risk for stroke initiating oral anticoagulants and a description of existing utilization patterns for warfarin and for the new oral anticoagulant (NOAC) medications as they become available over time. | Posted | Mean | Standard Deviation | Scores on a scale | From January 2009 to September 2015 (The study period) |
Safety related information was not captured during this study.
This was an observational study based on existing data (secondary data use); all patient data are de-identified and analyzed in aggregate. Individual patient safety related information was not designed to assess for this study; therefore the individual safety reporting was not applicable for this study.
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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 | Cohort UnitedHealth Dabigatran Users | Patients with a diagnosis of non-valvular atrial fibrillation (NVAF) new initiators of Dabigatran who were enrolled for a minimum of 12 months in UnitedHealth cohort before treatment initiation. |
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| Title | Organization | Phone | Extension | |
|---|---|---|---|---|
| Boehringer Ingelheim, Call Centre | 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 31, 2014 | Oct 25, 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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| From January 2009 to September 2015 (The study period) |
| Percentage of Patients Initiating Specific Anticoagulant Dose - Apixaban | Percentage of patients initiating specific anticoagulant dose of apixaban across all time periods combined in the unmatched cohort for UnitedHealth and MarketScan cohort are presented. Proportion of patients initiating specific anticoagulant over time per arm in source cohort is estimated and is expressed in percentage. | From January 2009 to September 2015 (The study period) |
| Percentage of Patients Initiating Specific Anticoagulant Dose - Rivaroxaban | Percentage of patients initiating specific anticoagulant dose of rivaroxaban across all time periods combined in the unmatched cohort for UnitedHealth and MarketScan cohort are presented. Proportion of patients initiating specific anticoagulant over time per arm in source cohort is estimated and is expressed in percentage. | From January 2009 to September 2015 (The study period) |
| From January 2009 to September 2015 (The study period) |
Patients with a diagnosis of non-valvular atrial fibrillation (NVAF) new initiators of Rivaroxaban who were enrolled for a minimum of 12 months in UnitedHealth cohort before treatment initiation. |
| BG002 | Cohort UnitedHealth Apixaban Users | Patients with a diagnosis of non-valvular atrial fibrillation (NVAF) new initiators of Apixaban who were enrolled for a minimum of 12 months in UnitedHealth cohort before treatment initiation. |
| BG003 | Cohort UnitedHealth WarfarinUsers (After Dabigatran Available) | Patients with a diagnosis of non-valvular atrial fibrillation (NVAF) new initiators of Warfarin after Dabigatran became available who were enrolled for a minimum of 12 months in UnitedHealth cohort before treatment initiation. |
| BG004 | Cohort UnitedHealth WarfarinUsers(Before Dabigatran Available) | Patients with a diagnosis of non-valvular atrial fibrillation (NVAF) new initiators of Warfarin before Dabigatran became available who were enrolled for a minimum of 12 months in UnitedHealth cohort before treatment initiation. |
| BG005 | Cohort MarketScan Dabigatran Users | Patients with a diagnosis of non-valvular atrial fibrillation (NVAF) new initiators of Dabigatran who were enrolled for a minimum of 12 months in MarketScan cohort before treatment initiation. |
| BG006 | Cohort MarketScan Rivaroxaban Users | Patients with a diagnosis of non-valvular atrial fibrillation (NVAF) new initiators of Rivaroxaban who were enrolled for a minimum of 12 months in MarketScan cohort before treatment initiation. |
| BG007 | Cohort MarketScan Apixaban Users | Patients with a diagnosis of non-valvular atrial fibrillation (NVAF) new initiators of Apixaban who were enrolled for a minimum of 12 months in MarketScan cohort before treatment initiation. |
| BG008 | Cohort MarketScan WarfarinUsers (After Dabigatran Available) | Patients with a diagnosis of non-valvular atrial fibrillation (NVAF) new initiators of Warfarin after Dabigatran became available who were enrolled for a minimum of 12 months in MarketScan cohort before treatment initiation. |
| BG009 | Cohort MarketScan WarfarinUsers(Before Dabigatran Available) | Patients with a diagnosis of non-valvular atrial fibrillation (NVAF) new initiators of Warfarin before Dabigatran became available who were enrolled for a minimum of 12 months in MarketScan cohort before treatment initiation. |
| BG010 | Total | Total of all reporting groups |
| Years |
|
| Sex: Female, Male | Count of Participants | Participants |
|
| Race and Ethnicity Not Collected | Race and Ethnicity were not collected from any participant. | Count of Participants | Participants |
|
|
|
|
| Primary | Percentage of Patients Initiating Specific Anticoagulant | Proportion of patients initiating specific anticoagulant over time per arm in source cohort is estimated and is expressed in percentage. This is related to UnitedHealth database and no treatment initiation rate was estimated in MarketScan as the study cohort was defined from a population of oral anticoagulants users. The overall number of participants analyzed "609201" reported for each of the treatment arm below corresponds to overall patients numbers in UnitedHealth for the entire study period rather than for each of the treatment arm. Likewise the number of participants for each of the treatment arm for different time period corresponds to the total number of participants for the specific study period rather than for each of the treatment arm. Incident users at given time period could also be counted in later time period if the patient discontinued the drug and had re-entry during the study period. | Source cohort in a calendar time window includes all patients with at least one day eligibility. A random date within the time window selected and set as the index date. Patients dispensed of an anticoagulant before assigned index date will be removed, unless they are identified as new initiators for that particular time period. | Posted | Number | Percentage of initiators (%) | From January 2009 to September 2015 (The study period) |
|
|
|
| Primary | Percentage of Patients Initiating Specific Anticoagulant Dose - Dabigatran | Percentage of patients initiating specific anticoagulant dose of dabigatran across all time periods combined in the unmatched cohort for UnitedHealth and MarketScan cohort are presented. Proportion of patients initiating specific anticoagulant over time per arm in source cohort is estimated and is expressed in percentage. | Patients initiating treatment in source cohort. | Posted | Number | Percentage of initiators (%) | From January 2009 to September 2015 (The study period) |
|
|
|
| Primary | Percentage of Patients Initiating Specific Anticoagulant Dose - Apixaban | Percentage of patients initiating specific anticoagulant dose of apixaban across all time periods combined in the unmatched cohort for UnitedHealth and MarketScan cohort are presented. Proportion of patients initiating specific anticoagulant over time per arm in source cohort is estimated and is expressed in percentage. | Patients initiating treatment in source cohort. | Posted | Number | Percentage of initiators (%) | From January 2009 to September 2015 (The study period) |
|
|
|
| Primary | Percentage of Patients Initiating Specific Anticoagulant Dose - Rivaroxaban | Percentage of patients initiating specific anticoagulant dose of rivaroxaban across all time periods combined in the unmatched cohort for UnitedHealth and MarketScan cohort are presented. Proportion of patients initiating specific anticoagulant over time per arm in source cohort is estimated and is expressed in percentage. | Patients initiating treatment in source cohort. | Posted | Number | Percentage of initiators (%) | From January 2009 to September 2015 (The study period) |
|
|
|
| Secondary | Treatment Persistence Over Time | Overall treatment persistence in UnitedHealth and MarketScan cohorts are presented as the percentage of patients who were persistent to treatment after 3, 6 and 12 months of follow-up for all time periods combined and matched cohort. Based on two US-based longitudinal healthcare claims databases (MarketScan and unitedHealth Research Database) the three separate study cohorts warfarin vs dabigatran, warfarin vs rivaroxaban and warfarin vs apixaban cohort were formed for each database. | Patients were matched within calendar quarters (3 months period) the various NOACs were individually matched to warfarin on an exposure propensity score (PS) in a 1:1 fixed ratio using a nearest neighbor technique and a caliper of 0.05. | Posted | Number | Percentage of participants (%) | From January 2009 to September 2015 (The study period) |
|
|
|
| 0 |
| 0 |
| 0 |
| 0 |
| 0 |
| 0 |
| EG001 | Cohort UnitedHealth Rivaroxaban Users | Patients with a diagnosis of non-valvular atrial fibrillation (NVAF) new initiators of Rivaroxaban who were enrolled for a minimum of 12 months in UnitedHealth cohort before treatment initiation. | 0 | 0 | 0 | 0 | 0 | 0 |
| EG002 | Cohort UnitedHealth Apixaban Users | Patients with a diagnosis of non-valvular atrial fibrillation (NVAF) new initiators of Apixaban who were enrolled for a minimum of 12 months in UnitedHealth cohort before treatment initiation. | 0 | 0 | 0 | 0 | 0 | 0 |
| EG003 | Cohort UnitedHealth WarfarinUsers (After Dabigatran Available) | Patients with a diagnosis of non-valvular atrial fibrillation (NVAF) new initiators of Warfarin after Dabigatran became available who were enrolled for a minimum of 12 months in UnitedHealth cohort before treatment initiation. | 0 | 0 | 0 | 0 | 0 | 0 |
| EG004 | Cohort UnitedHealth WarfarinUsers(Before Dabigatran Available) | Patients with a diagnosis of non-valvular atrial fibrillation (NVAF) new initiators of Warfarin before Dabigatran became available who were enrolled for a minimum of 12 months in UnitedHealth cohort before treatment initiation. | 0 | 0 | 0 | 0 | 0 | 0 |
| EG005 | Cohort MarketScan Dabigatran Users | Patients with a diagnosis of non-valvular atrial fibrillation (NVAF) new initiators of Dabigatran who were enrolled for a minimum of 12 months in MarketScan cohort before treatment initiation. | 0 | 0 | 0 | 0 | 0 | 0 |
| EG006 | Cohort MarketScan Rivaroxaban Users | Patients with a diagnosis of non-valvular atrial fibrillation (NVAF) new initiators of Rivaroxaban who were enrolled for a minimum of 12 months in MarketScan cohort before treatment initiation. | 0 | 0 | 0 | 0 | 0 | 0 |
| EG007 | Cohort MarketScan Apixaban Users | Patients with a diagnosis of non-valvular atrial fibrillation (NVAF) new initiators of Apixaban who were enrolled for a minimum of 12 months in MarketScan cohort before treatment initiation. | 0 | 0 | 0 | 0 | 0 | 0 |
| EG008 | Cohort MarketScan WarfarinUsers (After Dabigatran Available) | Patients with a diagnosis of non-valvular atrial fibrillation (NVAF) new initiators of Warfarin after Dabigatran became available who were enrolled for a minimum of 12 months in MarketScan cohort before treatment initiation. | 0 | 0 | 0 | 0 | 0 | 0 |
| EG009 | Cohort MarketScan WarfarinUsers(Before Dabigatran Available) | Patients with a diagnosis of non-valvular atrial fibrillation (NVAF) new initiators of Warfarin before Dabigatran became available who were enrolled for a minimum of 12 months in MarketScan cohort before treatment initiation. | 0 | 0 | 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 |
| Male |
|
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| October2010 - June2011 |
|
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| July2011 -Dec 2011 |
|
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| January2012-June2012 |
|
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| July2012-December2012 |
|
|
| January2013-June2013 |
|
|
| July2013-December2013 |
|
|
| January2014-June2014 |
|
|
| July2014-December2014 |
|
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| January2015-June2015 |
|
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| July2015-September2015 |
|
|
| 10 mg |
|
| After 6 months of follow-up |
|
| After 12 months of follow-up |
|