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| Name | Class |
|---|---|
| Janssen Scientific Affairs, LLC | INDUSTRY |
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The purpose of the study is to compare the one-year and two-year risk of each of the following individual outcomes: Stroke and systemic embolism (SE), major bleeding and death between new users of anticoagulant for Stroke prevention in atrial fibrillation (SPAF) during drug exposure: rivaroxaban versus Vitamin K antagonists (VKA), and rivaroxaban versus dabigatran
Main objective: To compare the one-year and two-year risk of each of the following individual outcomes: Stroke and systemic embolism (SE), major bleeding and death between new users of anticoagulant for SPAF during drug exposure: rivaroxaban versus VKA, and rivaroxaban versus dabigatran.
Secondary objectives:
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| Group 1 | Adult patients with nonvalvular atrial fibrillation (NVAF) treated with rivaroxaban |
| |
| Group 2 | Adult patients with nonvalvular atrial fibrillation (NVAF) treated with vitamin k anatognists |
| |
| Group 3 | Adult patients with nonvalvular atrial fibrillation (NVAF) treated with dabigatran |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| Rivaroxaban (Xarelto, BAY59-7939) | Drug | Tablets, 20mg once daily |
| |
| Measure | Description | Time Frame |
|---|---|---|
| Stroke and systemic embolism (Effectiveness outcome) | Hospitalization with ischemic or undefined stroke or other systemic arterial embolism or surgical procedure for systemic arterial embolism To compare one year and two year risk between new users of anticoagulant for SPAF during drug exposure: rivaroxaban versus VKA, and rivaroxaban versus dabigatran. | One year and Two Year |
| Major Bleeding | Hospitalization with haemorrhagic stroke, other critical organ or site bleeding (intraspinal, intraocular,retroperitoneal, intraarticular or pericardial, or intramuscular), Other bleeding with a transfusion during hospital stay, or resulting in death. To compare one year and two year risk between new users of anticoagulant for SPAF during drug exposure: rivaroxaban versus VKA, and rivaroxaban versus dabigatran. | One year and Two Year |
| Death | All-cause death. To compare one year and two year risk between new users of anticoagulant for SPAF during drug exposure: rivaroxaban versus VKA, and rivaroxaban versus dabigatran. | One year and Two Year |
| Measure | Description | Time Frame |
|---|---|---|
| Pattern of use (Exposure, Adherence, Discontinuation, Switch) | To describe the drug exposure to rivaroxaban, dabigatran, and VKA for SPAF in new users and pattern of use | Up to two years |
| A composite of stroke and SE, major bleeding and death, clinically relevant bleeding and acute coronary syndrome |
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Inclusion Criteria:
Exclusion Criteria:
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All subjects with a first reimbursed dispensation of rivaroxaban (15 or 20 mg), dabigatran (110 or 150 mg) or vitamin k antagonists in 2013 or 2014 diagnosed with Atrial Fibrillation
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| Name | Affiliation | Role |
|---|---|---|
| Bayer Study Director | Bayer | Study Director |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| Many Locations | Multiple Locations | France |
| PubMed Identifier | Type | Citation | Retractions |
|---|---|---|---|
| 31390972 | Background | Blin P, Fauchier L, Dureau-Pournin C, Sacher F, Dallongeville J, Bernard MA, Lassalle R, Droz-Perroteau C, Moore N. Effectiveness and Safety of Rivaroxaban 15 or 20 mg Versus Vitamin K Antagonists in Nonvalvular Atrial Fibrillation. Stroke. 2019 Sep;50(9):2469-2476. doi: 10.1161/STROKEAHA.119.025824. Epub 2019 Aug 8. | |
| 31638652 |
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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 |
|---|---|
| D000069552 | Rivaroxaban |
| C008208 | acarboxyprothrombin |
| D000069604 | Dabigatran |
| ID | Term |
|---|---|
| D013876 | Thiophenes |
| D013457 | Sulfur Compounds |
| D009930 | Organic Chemicals |
| D009025 | Morpholines |
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| Vitamin K antagonists |
| Drug |
Tablets, dose is based on International Normalized Ratio |
|
| dabigatran (Pradaxa) | Drug | Tablets, 150 mg twice daily |
|
To compare one year and two year risk between new users of anticoagulant for SPAF during drug exposure: rivaroxaban vs VKA, and rivaroxaban vs dabigatran |
| One year and Two Year |
| Cumulative incidence and incidence rate of stroke and SE, major bleeding, clinically relevant bleeding, death, composite criteria, and acute coronary syndrome as well as according individual diagnose of each of these outcomes | During drug exposure for rivaroxaban, dabigatran, and VKA | Up to two years |
| Cumulative incidence of Stroke and SE, major bleeding, clinically relevant bleeding, death, composite criteria, and acute coronary syndrome as well as according individual diagnose of each of these outcomes | Post-anticoagulant exposure for rivaroxaban, dabigatran, and VKA (i.e. after anticoagulant discontinuation) | Up to two years |
| Healthcare resources utilisation | Healthcare resources use will be described from reimbursed claims and hospitalisation information Healthcare resources cost will be estimated using the French HAS methodological guide for economic evaluations (2011) | Up to two years |
| Fauchier L, Blin P, Sacher F, Dureau-Pournin C, Bernard MA, Lassalle R, Droz-Perroteau C, Dallongeville J, Moore N. Reduced dose of rivaroxaban and dabigatran vs. vitamin K antagonists in very elderly patients with atrial fibrillation in a nationwide cohort study. Europace. 2020 Feb 1;22(2):205-215. doi: 10.1093/europace/euz285. |
| D013568 |
| Pathological Conditions, Signs and Symptoms |
| D010078 |
| Oxazines |
| D006573 | Heterocyclic Compounds, 1-Ring |
| D006571 | Heterocyclic Compounds |
| D011725 | Pyridines |
| D001562 | Benzimidazoles |
| D006574 | Heterocyclic Compounds, 2-Ring |
| D000072471 | Heterocyclic Compounds, Fused-Ring |