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| Name | Class |
|---|---|
| Janssen Research & Development, LLC | INDUSTRY |
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Evaluation of the performance of the 2MACE index in a population of nonvalvular atrial fibrillation (NVAF) patients treated with rivaroxaban in Spain
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| Rivaroxaban | Non-valvular atrial fibrillation (NVAF) patients treated with rivaroxaban for at least 6 months prior to the study inclusion |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| Rivaroxaban (Xarelto, BAY59-7939) | Drug | As prescribed by the treating physician |
|
| Measure | Description | Time Frame |
|---|---|---|
| 2MACE score | MACE: Major adverse cardiovascular events. 2MACE: History of Myocardial infarction/ Cardiac revascularization and Metabolic Syndrome, Age >75 years, Congestive heart failure (ejection fraction <40%), Thrombo-Embolism | At baseline |
| Occurrence of MACE to evaluate the performance of the 2MACE index | Percentage of patients with MACE including fatal/nonfatal myocardial infarction, cardiac revascularization and cardiovascular death | At 2 years and 6 months or early termination |
| Measure | Description | Time Frame |
|---|---|---|
| Incorporation of additional risk factors to the 2MACE index or replacing some of the existing ones | Risk factors to the 2MACE index (e.g. body mass index, smoking, drugs use, estimated glomerular filtration rate, structural cardio-pathology) | At baseline |
| Occurrence of major cardiovascular events (fatal/nonfatal myocardial infarction, cardiac revascularization and cardiovascular death) |
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Inclusion Criteria:
Exclusion Criteria:
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Adult patients diagnosed with non-valvular atrial fibrillation who are under rivaroxaban treatment and that attend the Cardiology Units at Spanish hospitals and private clinics
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| Name | Affiliation | Role |
|---|---|---|
| Bayer Study Director | Bayer | Study Director |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| Multiple Locations | Spain |
| PubMed Identifier | Type | Citation | Retractions |
|---|---|---|---|
| 37487406 | Background | Rivera-Caravaca JM, Anguita Sanchez M, Sanmartin Fernandez M, Rafols C, Baron-Esquivias G, Arribas Ynsaurriaga F, Freixa-Pamias R, Lekuona Goya I, Vazquez Rodriguez JM, Perez-Cabeza AI, Cosin-Sales J, Urena Montilla I, Alvarez-Vieitez Blanco A, Marin F. Adverse Clinical Outcomes and Associated Predictors in Rivaroxaban-Treated Atrial Fibrillation Patients With Renal Impairment. Am J Cardiol. 2023 Sep 15;203:122-127. doi: 10.1016/j.amjcard.2023.06.105. Epub 2023 Jul 22. |
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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 |
| ID | Term |
|---|---|
| D013876 | Thiophenes |
| D013457 | Sulfur Compounds |
| D009930 | Organic Chemicals |
| D009025 | Morpholines |
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| At baseline, at 1 year, at 2 years, at 2 years and 6 months or early termination |
| Occurrence of stroke | At baseline, at 1 year, at 2 years, at 2 years and 6 months or early termination |
| Occurrence of transient ischemic attack (TIA) | At baseline, at 1 year, at 2 years, at 2 years and 6 months or early termination |
| Occurrence of systemic embolism | At baseline, at 1 year, at 2 years, at 2 years and 6 months or early termination |
| Thromboembolic risk based on the CHADS2 score | CHADS2: Cardiac Failure, Hypertension, Age, Diabetes, Stroke | At baseline |
| Thromboembolic risk based on the CHA2DS2-VASC | CHA2DS2-VASc:Cardiac failure, Hypertension, Age ≥75, Diabetes, Stroke -Vascular disease, Age and Sex category | At baseline |
| Number of MACEs occurring during the study | At 1 year, at 2 years, at 2 years and 6 months or early termination |
| Patients' profile | Baseline patients' profile defined by: sociodemographic data, anthropometric data, previous relevant medical history, cardiac medical history distinct to atrial fibrillation, comorbidities (renal failure, left ventricular dysfunction, hypertension, thyroid dysfunction, liver failure, alcoholism) | At baseline |
| Number of cases (frequency) of metabolism syndrome at enrollment with/without the occurrence of myocardial infarction or coronary revascularization | At baseline |
| D013568 |
| Pathological Conditions, Signs and Symptoms |
| D010078 |
| Oxazines |
| D006573 | Heterocyclic Compounds, 1-Ring |
| D006571 | Heterocyclic Compounds |