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This cohort study plans to identify initiators of oral anticoagulants using electronic claims data from a commercial insurance database to quantify associations between anticoagulant choice (warfarin and dabigatran) and the occurrence of selected outcomes in patients with non-valvular atrial fibrillation at risk for stroke.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| Dabigatran | |||
| Warfarin |
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| Measure | Description | Time Frame |
|---|---|---|
| Incidence Rate of Stroke | Events during follow-up (October 2010- 30 June 2012) were identified using ICD 9 codes. | From treatment initiation until end of follow-up; up to 20 months |
| Incidence Rate of Major Bleeding | Events during follow-up (October 2010- 30 June 2012) were identified using ICD 9 and procedure codes. | From treatment initiation until end of follow-up; up to 20 months |
| Measure | Description | Time Frame |
|---|---|---|
| Incidence Rate of Myocardial Infarction | Events during follow-up (October 2010- 30 June 2012) were identified using ICD 9 codes. | From treatment initiation until end of follow-up; up to 20 months |
| Incidence Rate of Venous Thromboembolism |
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Inclusion criteria:
Exclusion criteria:
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Patients 18 years of age and older with non-valvular AF initiating oral anticoagulation therapy
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| Name | Affiliation | Role |
|---|---|---|
| Boehringer Ingelheim | Boehringer Ingelheim | Study Chair |
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11882 patients fulfilled the in- and ex-clusion criteria. Only 5982 patients remained after matching on the Propensity Score.
This is an observational study. Patients were not actively recruited in this study. The data source was the UnitedHealth database.
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| ID | Title | Description |
|---|---|---|
| FG000 | Dabigatran | Propensity score matched patients starting treatment with dabigatran |
| FG001 | Warfarin | Propensity score matched patients starting treatment with warfarin |
| Title | Milestones | Reasons Not Completed | ||||||||||||
|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|
| Overall Study |
|
This initial cohort study includes matched treatment groups of 2,991 patients with non-valvular atrial fibrillation who initiated dabigatran and 2,991 patients who initiated warfarin that were drawn from a pool of 11,882 eligible initiators. These first feasibility data are limited by a small sample size.
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| ID | Title | Description |
|---|---|---|
| BG000 | Dabigatran | Propensity score matched patients starting treatment with dabigatran |
| BG001 | Warfarin | Propensity score matched patients starting treatment with 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 | Incidence Rate of Stroke | Events during follow-up (October 2010- 30 June 2012) were identified using ICD 9 codes. | Hazard ratios and confidence intervals were estimated for patients starting dabigatran or warfarin after matching on the propensity score. | Posted | Number | events per 1000 person years | From treatment initiation until end of follow-up; up to 20 months |
|
Up to 20 months
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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 | Propensity score matched patients starting treatment with dabigatran |
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These first data are limited by small sample size, short follow up, few events resulting in wide confidence intervals. No comparative conclusions are possible. After the feasibility analysis future analysis will increase patient numbers and follow up
| Title | Organization | Phone | Extension | |
|---|---|---|---|---|
| Boehringer Ingelheim Call Center | Boehringer Ingelheim Pharmaceuticals | 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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Events during follow-up (October 2010- 30 June 2012) were identified using ICD 9 codes.
| From treatment initiation until end of follow-up; up to 20 months |
| Incidence Rate of Deep Vein Thrombosis | Events during follow-up (October 2010- 30 June 2012) were identified using ICD 9 codes. | From treatment initiation until end of follow-up; up to 20 months |
| Incidence Rate of Pulmonary Embolism | Events during follow-up (October 2010- 30 June 2012) were identified using ICD 9 codes. | From treatment initiation until end of follow-up; up to 20 months |
| Incidence Rate of Major Lower Gastrointestinal Bleeding | Events during follow-up (October 2010- 30 June 2012) were identified using ICD 9 codes. | From treatment initiation until end of follow-up; up to 20 months |
| Incidence Rate of Major Urogenital Bleeding | Events during follow-up (October 2010- 30 June 2012) were identified using ICD 9 codes. | From treatment initiation until end of follow-up; up to 20 months |
| Incidence Rate of Major Other Bleeding | Events during follow-up (October 2010- 30 June 2012) were identified using ICD 9 codes. | From treatment initiation until end of follow-up; up to 20 months |
| Incidence Rate of Transient Ischemic Attack | Events during follow-up (October 2010- 30 June 2012) were identified using ICD 9 codes. | From treatment initiation until end of follow-up; up to 20 months |
| Incidence Rate of Major Upper Gastrointestinal Bleeding | Events during follow-up (October 2010- 30 June 2012) were identified using ICD 9 and procedure codes. | From treatment initiation until end of follow-up; up to 20 months |
| Incidence Rate of Stroke or Systemic Embolism | Events during follow-up (October 2010- 30 June 2012) were identified using ICD 9 codes. | From treatment initiation until end of follow-up; up to 20 months |
| Incidence Rate of Systemic Embolism | Events during follow-up (October 2010- 30 June 2012) were identified using ICD 9 codes. | From treatment initiation until end of follow-up; up to 20 months |
| Incidence Rate of Ischemic Stroke | Events during follow-up (October 2010- 30 June 2012) were identified using ICD 9 codes. | From treatment initiation until end of follow-up; up to 20 months |
| Incidence Rate of Hemorrhagic Stroke | Events during follow-up (October 2010- 30 June 2012) were identified using ICD 9 codes. | From treatment initiation until end of follow-up; up to 20 months |
| Incidence Rate of Stroke Uncertain Classification | Events during follow-up (October 2010- 30 June 2012) were identified using ICD 9. | From treatment initiation until end of follow-up; up to 20 months |
| Incidence Rate of Major Intracranial Bleeding | Events during follow-up (October 2010- 30 June 2012) were identified using ICD 9 codes. | From treatment initiation until end of follow-up; up to 20 months |
| Incidence Rate of Major Extracranial Bleeding | Events during follow-up (October 2010- 30 June 2012) were identified using ICD 9 and procedure codes. | From treatment initiation until end of follow-up; up to 20 months |
| Incidence Rate of Major Gastrointestinal Bleeding | Events during follow-up (October 2010- 30 June 2012) were identified using ICD 9 and procedure codes. | From treatment initiation until end of follow-up; up to 20 months |
| BG002 | Total | Total of all reporting groups |
| years |
|
| Sex: Female, Male | Count of Participants | Participants |
|
| Units | Counts |
|---|---|
| Participants |
|
|
|
| Primary | Incidence Rate of Major Bleeding | Events during follow-up (October 2010- 30 June 2012) were identified using ICD 9 and procedure codes. | Hazard ratios and confidence intervals were estimated for patients starting dabigatran or warfarin after matching on the propensity score. | Posted | Number | events per 1000 person years | From treatment initiation until end of follow-up; up to 20 months |
|
|
|
|
| Secondary | Incidence Rate of Myocardial Infarction | Events during follow-up (October 2010- 30 June 2012) were identified using ICD 9 codes. | Hazard ratios and confidence intervals were estimated for patients starting dabigatran or warfarin after matching on the propensity score. | Posted | Number | events per 1000 person years | From treatment initiation until end of follow-up; up to 20 months |
|
|
|
|
| Secondary | Incidence Rate of Venous Thromboembolism | Events during follow-up (October 2010- 30 June 2012) were identified using ICD 9 codes. | Hazard ratios and confidence intervals were estimated for patients starting dabigatran or warfarin after matching on the propensity score. | Posted | Number | events per 1000 person years | From treatment initiation until end of follow-up; up to 20 months |
|
|
|
|
| Secondary | Incidence Rate of Deep Vein Thrombosis | Events during follow-up (October 2010- 30 June 2012) were identified using ICD 9 codes. | Hazard ratios and confidence intervals were estimated for patients starting dabigatran or warfarin after matching on the propensity score. | Posted | Number | events per 1000 person years | From treatment initiation until end of follow-up; up to 20 months |
|
|
|
|
| Secondary | Incidence Rate of Pulmonary Embolism | Events during follow-up (October 2010- 30 June 2012) were identified using ICD 9 codes. | Hazard ratios and confidence intervals were estimated for patients starting dabigatran or warfarin after matching on the propensity score. | Posted | Number | events per 1000 person years | From treatment initiation until end of follow-up; up to 20 months |
|
|
|
|
| Secondary | Incidence Rate of Major Lower Gastrointestinal Bleeding | Events during follow-up (October 2010- 30 June 2012) were identified using ICD 9 codes. | Hazard ratios and confidence intervals were estimated for patients starting dabigatran or warfarin after matching on the propensity score. | Posted | Number | events per 1000 person years | From treatment initiation until end of follow-up; up to 20 months |
|
|
|
|
| Secondary | Incidence Rate of Major Urogenital Bleeding | Events during follow-up (October 2010- 30 June 2012) were identified using ICD 9 codes. | Hazard ratios and confidence intervals were estimated for patients starting dabigatran or warfarin after matching on the propensity score. | Posted | Number | events per 1000 person years | From treatment initiation until end of follow-up; up to 20 months |
|
|
|
| Secondary | Incidence Rate of Major Other Bleeding | Events during follow-up (October 2010- 30 June 2012) were identified using ICD 9 codes. | Hazard ratios and confidence intervals were estimated for patients starting dabigatran or warfarin after matching on the propensity score. | Posted | Number | events per 1000 person years | From treatment initiation until end of follow-up; up to 20 months |
|
|
|
|
| Secondary | Incidence Rate of Transient Ischemic Attack | Events during follow-up (October 2010- 30 June 2012) were identified using ICD 9 codes. | Hazard ratios and confidence intervals were estimated for patients starting dabigatran or warfarin after matching on the propensity score. | Posted | Number | events per 1000 person years | From treatment initiation until end of follow-up; up to 20 months |
|
|
|
|
| Secondary | Incidence Rate of Major Upper Gastrointestinal Bleeding | Events during follow-up (October 2010- 30 June 2012) were identified using ICD 9 and procedure codes. | Hazard ratios and confidence intervals were estimated for patients starting dabigatran or warfarin after matching on the propensity score. | Posted | Number | events per 1000 person years | From treatment initiation until end of follow-up; up to 20 months |
|
|
|
|
| Secondary | Incidence Rate of Stroke or Systemic Embolism | Events during follow-up (October 2010- 30 June 2012) were identified using ICD 9 codes. | Hazard ratios and confidence intervals were estimated for patients starting dabigatran or warfarin after matching on the propensity score. | Posted | Number | events per 1000 person years | From treatment initiation until end of follow-up; up to 20 months |
|
|
|
|
| Secondary | Incidence Rate of Systemic Embolism | Events during follow-up (October 2010- 30 June 2012) were identified using ICD 9 codes. | Hazard ratios and confidence intervals were estimated for patients starting dabigatran or warfarin after matching on the propensity score. | Posted | Number | events per 1000 person years | From treatment initiation until end of follow-up; up to 20 months |
|
|
|
|
| Secondary | Incidence Rate of Ischemic Stroke | Events during follow-up (October 2010- 30 June 2012) were identified using ICD 9 codes. | Hazard ratios and confidence intervals were estimated for patients starting dabigatran or warfarin after matching on the propensity score. | Posted | Number | events per 1000 person years | From treatment initiation until end of follow-up; up to 20 months |
|
|
|
|
| Secondary | Incidence Rate of Hemorrhagic Stroke | Events during follow-up (October 2010- 30 June 2012) were identified using ICD 9 codes. | Hazard ratios and confidence intervals were estimated for patients starting dabigatran or warfarin after matching on the propensity score. | Posted | Number | events per 1000 person years | From treatment initiation until end of follow-up; up to 20 months |
|
|
|
|
| Secondary | Incidence Rate of Stroke Uncertain Classification | Events during follow-up (October 2010- 30 June 2012) were identified using ICD 9. | Hazard ratios and confidence intervals were estimated for patients starting dabigatran or warfarin after matching on the propensity score. | Posted | Number | events per 1000 person years | From treatment initiation until end of follow-up; up to 20 months |
|
|
|
|
| Secondary | Incidence Rate of Major Intracranial Bleeding | Events during follow-up (October 2010- 30 June 2012) were identified using ICD 9 codes. | Hazard ratios and confidence intervals were estimated for patients starting dabigatran or warfarin after matching on the propensity score. | Posted | Number | events per 1000 person years | From treatment initiation until end of follow-up; up to 20 months |
|
|
|
|
| Secondary | Incidence Rate of Major Extracranial Bleeding | Events during follow-up (October 2010- 30 June 2012) were identified using ICD 9 and procedure codes. | Hazard ratios and confidence intervals were estimated for patients starting dabigatran or warfarin after matching on the propensity score. | Posted | Number | events per 1000 person years | From treatment initiation until end of follow-up; up to 20 months |
|
|
|
|
| Secondary | Incidence Rate of Major Gastrointestinal Bleeding | Events during follow-up (October 2010- 30 June 2012) were identified using ICD 9 and procedure codes. | Hazard ratios and confidence intervals were estimated for patients starting dabigatran or warfarin after matching on the propensity score. | Posted | Number | events per 1000 person years | From treatment initiation until end of follow-up; up to 20 months |
|
|
|
|
| 0 |
| 2,991 |
| 0 |
| 2,991 |
| EG001 | Warfarin | Propensity score matched patients starting treatment with warfarin | 0 | 2,991 | 0 | 2,991 |
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| D013568 |
| Pathological Conditions, Signs and Symptoms |