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| Name | Class |
|---|---|
| Janssen Research & Development, LLC | INDUSTRY |
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This population-based descriptive study will characterize first-time users of three NOACs (rivaroxaban, dabigatran and apixaban) in prevention of stroke in non-valvular atrial fibrillation (SPAF) patients and will assess the patterns of drug utilization in routine general practice in Colombia
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| SPAF patients in Colombia_Rivaroxaban | First time users of rivaroxaban in the Audifarma database |
| |
| SPAF patients in Colombia_Dabigatran | First time users of dabigatran in the Audifarma database |
| |
| SPAF patients in Colombia_Apixaban | First time users of apixaban in the Audifarma database |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| Data Collection | Other | Data will be extracted from July 2009 to the last available database extraction |
|
| Measure | Description | Time Frame |
|---|---|---|
| Age | At Baseline | |
| Sex | At Baseline | |
| Co-morbidity | At Baseline | |
| Healthcare utilization | Primary Care Physicians visits, Outpatient visits and Hospital admissions | Up to 2 years |
| Proportion of Naive to non-naive patient | At Baseline | |
| Dose at first prescription | Up to 6 years | |
| Duration of treatment | Up to 6 years | |
| Discontinuation | Up to 6 years | |
| Switch to another study drug | Up to 6 years |
| Measure | Description | Time Frame |
|---|---|---|
| Time trends of usage of study medications | Up to 6 years |
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Inclusion Criteria:
Exclusion Criteria:
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Using the population from the Audifarma database, the study will be comprised of three separate cohorts of first time users of rivaroxaban, dabigatran and apixaban using the first prescription date (index date) of the respective drug (index drug). All patients aged ≥18 years with at least one year of enrollment in the databases and one year since first encounter with healthcare provider will be included in the study.
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| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| Many Locations | Multiple Locations | Colombia |
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| Label | URL |
|---|---|
| Related Info | View source |
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| ID | Term |
|---|---|
| D001281 | Atrial Fibrillation |
| ID | Term |
|---|---|
| D001145 | Arrhythmias, Cardiac |
| D006331 | Heart Diseases |
| D002318 | Cardiovascular Diseases |
| D010335 | Pathologic Processes |
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| ID | Term |
|---|---|
| D003625 | Data Collection |
| ID | Term |
|---|---|
| D004812 | Epidemiologic Methods |
| D008919 | Investigative Techniques |
| D017531 | Health Care Evaluation Mechanisms |
| D011787 | Quality of Health Care |
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| D013568 |
| Pathological Conditions, Signs and Symptoms |
| D017530 | Health Care Quality, Access, and Evaluation |
| D011634 | Public Health |
| D004778 | Environment and Public Health |