Atrial Fibrillation
Conditions
Brief summary
Evaluation of the performance of the 2MACE index in a population of nonvalvular atrial fibrillation (NVAF) patients treated with rivaroxaban in Spain
Interventions
DRUGRivaroxaban (Xarelto, BAY59-7939)
As prescribed by the treating physician
Sponsors
Janssen Research & Development, LLC
Bayer
Study design
Observational model
COHORT
Time perspective
PROSPECTIVE
Eligibility
Sex/Gender
ALL
Age
18 Years to No maximum
Healthy volunteers
No
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).
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| 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
| Measure | Time frame | Description |
|---|---|---|
| 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 |
| 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) |
| 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 | — |
| Thromboembolic risk based on the CHA2DS2-VASC | At baseline | CHA2DS2-VASc:Cardiac failure, Hypertension, Age ≥75, Diabetes, Stroke -Vascular disease, Age and Sex category |
| 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 | — |
Countries
Spain
Outcome results
None listed