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The purpose of this study is to evaluate the APIXABAN use in the Prevention of Stroke and Systemic Embolism in Patients with Atrial Fibrillation in Real-Life Setting in France, data from SNIIRAM (French data base).
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| AC-naive treated with VKA | AC-naive treated with VKA |
| |
| AC-naive treated with apixaban | AC-naive treated with apixaban |
| |
| AC-naive treated with dabigatran | AC-naive treated with dabigatran |
| |
| AC-naive treated with rivaroxaban | AC-naive treated with rivaroxaban |
| |
| AC-experienced treated with VKA | AC-experienced treated with VKA |
| |
| AC-experienced treated with apixaban | AC-experienced treated with apixaban |
| |
| AC-experienced treated with dabigatran |
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| VKA | Drug |
|
| |
| Measure | Description | Time Frame |
|---|---|---|
| Incidence rate of first event of stroke and/or systemic embolism over the period of AC exposure | Estimation by AC treatment and for both populations (AC-naive and AC-experienced patients) of Incidence rate (95%CI) of first event of stroke and/or systemic embolism (effectiveness) and of first event of major bleeding (safety) over the period of AC ex | Approximately 2 years |
| Time-to-first occurrence of stroke or systemic embolism will be estimated and plotted using Kaplan-Meier product limit estimator | Estimation by AC treatment and for both populations (AC-naive and AC-experienced patients) of Time-to-first occurrence of stroke and/or systemic embolism (effectiveness) and of major bleedings (safety) using Kaplan-Meier product limit estimator (95%CI) | Approximately 2 years |
| Measure | Description | Time Frame |
|---|---|---|
| Incidence rates for composite morbidity criterion and all-cause death over the period of AC exposure will be estimated by AC treatment |
|
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Inclusion Criteria:
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AC-naive and AC-experienced patients diagnosed with non-valvular AF, initiated with either apixaban, dabigatran, rivaroxaban or VKAs
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| Name | Affiliation | Role |
|---|---|---|
| Bristol-Myers Squibb | Bristol-Myers Squibb | Study Director |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| Rueil-Malmaison | France |
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| Label | URL |
|---|---|
| BMS Clinical Trial Information | View source |
| FDA Safety Alerts and Recalls | View source |
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| ID | Term |
|---|---|
| C008208 | acarboxyprothrombin |
| C522181 | apixaban |
| D000069604 | Dabigatran |
| D000069552 | Rivaroxaban |
| ID | Term |
|---|---|
| D011725 | Pyridines |
| D006573 | Heterocyclic Compounds, 1-Ring |
| D006571 | Heterocyclic Compounds |
| D001562 | Benzimidazoles |
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AC-experienced treated with dabigatran |
|
| AC-experienced treated with rivaroxaban | AC-experienced treated with rivaroxaban |
|
| Apixaban |
| Drug |
|
| dabigatran | Drug |
|
| rivaroxaban | Drug |
|
| Approximately 2 years |
| Time-to-event for composite morbidity criterion and all-cause death using Kaplan-Meier product limit estimator (95%CI) | Approximately 2 years |
| Major characteristics of patients will be described by AC treatments | Major characteristics of patients and comorbidities were:
| Approximately 2 years |
| Treatment patterns at AC initiation, over time and concomitant treatment will be tabulated by AC treatment | Treatment patterns at AC initiation: Type of the prescriber initiating the AC treatment (general practitioners, office-based cardiologists, hospital-based physicians and others), prescribed dosages, duration of initial prescription, co prescription (others AC, antiplatelet agents, NSAIDs, SRIs, strong inhibitors of both CYP3A4, anticonvulsivant strong inducer of hepatic enzymes, rifampicine, antiarrhythmic drugs) | Approximately 2 years |
| Time-to-discontinuation will be estimated and plotted using Kaplan-Meier product limit estimator | Time-to-discontinuation will be estimated and plotted using Kaplan-Meier product limit estimator based on Adherence to treatment: mean Medication Possession Ratio (MPR), Persistence: number for AC treatment discontinuation, median time to discontinuation | Approximately 2 years |
| The healthcare resources utilization will be described by AC treatment | The healthcare resources utilization will be described by AC treatment based on number of medical visits, number of nurse acts, per category of act, number of drugs packages per therapeutic classes, number of biology and tests, per type of act, number of other explorations, number of hospital stays, number of sick leaves | Approximately 2 years |
| Comparisons of major characteristics of patients between apixaban and each of the other AC treatments | Comparisons of major characteristics of patients between apixaban and each of the other AC treatments will be performed using:
| Approximately 2 years |
| Comparison of incidence rates of each studied event (stroke or systemic thromboembolic event, major bleeding, all-cause death) between apixaban and each of the other usual AC treatments | Approximately 2 years |
| Comparative time-to-event analyses for each studied event between apixaban and each of the other usual AC treatments | Approximately 2 years |
| D006574 |
| Heterocyclic Compounds, 2-Ring |
| D000072471 | Heterocyclic Compounds, Fused-Ring |
| D013876 | Thiophenes |
| D013457 | Sulfur Compounds |
| D009930 | Organic Chemicals |
| D009025 | Morpholines |
| D010078 | Oxazines |