Study of Major Cardiovascular Events in Patients With Nonvalvular Atrial Fibrillation Treated With Rivaroxaban

Study Overview
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Brief Summary
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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

Official Title
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Study of Risk Factors of Major Cardiovascular Events in Patients With Nonvalvular Atrial Fibrillation Treated With a Direct Oral Anticoagulant (Rivaroxaban)

Conditions
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Atrial Fibrillation

Intervention / Treatment
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* Drug: Rivaroxaban (Xarelto, BAY59-7939)


Participation Criteria
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Eligibility Criteria
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Inclusion Criteria: Adult patients aged 18 years or older. Patients with diagnosis of NVAF. Patients treated with rivaroxaban from at least six months prior to the study inclusion. Patients who have been given appropriate information about the study objectives and procedures and who have given their written informed consent. Exclusion Criteria: Patients participating in an investigational program with interventions outside of routine clinical practice. Patients who initiate treatment with rivaroxaban after the start of the study inclusion period. Prosthetic heart valves or the presence of any severe valvulopathies. Patients with severe cognitive impairment. Patients with chronic infections (HIV infection, hepatitis C virus, hepatitis B virus) or systemic autoimmune diseases. Patients with active cancer. Patients with liver insufficiency (eg. cirrhosis).

Ages Eligible for Study
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Minimum Age: 18 Years

Sexes Eligible for Study
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All

Accepts Healthy Volunteers
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No

Study Plan
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How is the study designed?
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Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Rivaroxaban<br>Non-valvular atrial fibrillation (NVAF) patients treated with rivaroxaban for at least 6 months prior to the study inclusion | Drug: Rivaroxaban (Xarelto, BAY59-7939)<br>* As prescribed by the treating physician<br>|

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | 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 | 

Secondary Outcome Measures

| Outcome Measure | 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) |  | 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 |