EMIR: Study of Major Cardiovascular Events in Patients With Nonvalvular Atrial Fibrillation Treated With Rivaroxaban
Study Details
Study Description
Brief Summary
Evaluation of the performance of the 2MACE index in a population of nonvalvular atrial fibrillation (NVAF) patients treated with rivaroxaban in Spain
| Condition or Disease | Intervention/Treatment | Phase |
|---|---|---|
|
Study Design
Arms and Interventions
| Arm | Intervention/Treatment |
|---|---|
| Rivaroxaban Non-valvular atrial fibrillation (NVAF) patients treated with rivaroxaban for at least 6 months prior to the study inclusion |
Drug: Rivaroxaban (Xarelto, BAY59-7939)
As prescribed by the treating physician
|
Outcome Measures
Primary Outcome Measures
- 2MACE score [At baseline]
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
- Occurrence of MACE to evaluate the performance of the 2MACE index [At 2 years and 6 months or early termination]
Percentage of patients with MACE including fatal/nonfatal myocardial infarction, cardiac revascularization and cardiovascular death
Secondary Outcome Measures
- Incorporation of additional risk factors to the 2MACE index or replacing some of the existing ones [At baseline]
Risk factors to the 2MACE index (e.g. body mass index, smoking, drugs use, estimated glomerular filtration rate, structural cardio-pathology)
- 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 [At baseline]
CHADS2: Cardiac Failure, Hypertension, Age, Diabetes, Stroke
- Thromboembolic risk based on the CHA2DS2-VASC [At baseline]
CHA2DS2-VASc:Cardiac failure, Hypertension, Age ≥75, Diabetes, Stroke -Vascular disease, Age and Sex category
- Number of MACEs occurring during the study [At 1 year, at 2 years, at 2 years and 6 months or early termination]
- Patients' profile [At baseline]
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)
- Number of cases (frequency) of metabolism syndrome at enrollment with/without the occurrence of myocardial infarction or coronary revascularization [At baseline]
Eligibility Criteria
Criteria
Inclusion Criteria:
-
Adult patients aged 18 years or older.
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Patients with diagnosis of NVAF.
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Patients treated with rivaroxaban from at least six months prior to the study inclusion.
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Patients who have been given appropriate information about the study objectives and procedures and who have given their written informed consent.
Exclusion Criteria:
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Patients participating in an investigational program with interventions outside of routine clinical practice.
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Patients who initiate treatment with rivaroxaban after the start of the study inclusion period.
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Prosthetic heart valves or the presence of any severe valvulopathies.
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Patients with severe cognitive impairment.
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Patients with chronic infections (HIV infection, hepatitis C virus, hepatitis B virus) or systemic autoimmune diseases.
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Patients with active cancer.
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Patients with liver insufficiency (eg. cirrhosis).
Contacts and Locations
Locations
| Site | City | State | Country | Postal Code | |
|---|---|---|---|---|---|
| 1 | Multiple Locations | Spain |
Sponsors and Collaborators
- Bayer
- Janssen Research & Development, LLC
Investigators
- Study Director: Bayer Study Director, Bayer
Study Documents (Full-Text)
None provided.More Information
Additional Information:
Publications
None provided.- 18884