Study of Major Cardiovascular Events in Patients With Nonvalvular Atrial Fibrillation Treated With Rivaroxaban
- Registration Number
- NCT02975453
- Lead Sponsor
- Bayer
- Brief Summary
Evaluation of the performance of the 2MACE index in a population of nonvalvular atrial fibrillation (NVAF) patients treated with rivaroxaban in Spain
- Detailed Description
Not available
Recruitment & Eligibility
- Status
- COMPLETED
- Sex
- All
- Target Recruitment
- 1481
- 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.
- 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).
Study & Design
- Study Type
- OBSERVATIONAL
- Study Design
- Not specified
- Arm && Interventions
Group Intervention Description Rivaroxaban Rivaroxaban (Xarelto, BAY59-7939) Non-valvular atrial fibrillation (NVAF) patients treated with rivaroxaban for at least 6 months prior to the study inclusion
- Primary Outcome Measures
Name Time Method 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
Name Time Method 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 stroke At baseline, at 1 year, at 2 years, at 2 years and 6 months or early termination 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 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
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)
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 Number of MACEs occurring during the study At 1 year, at 2 years, at 2 years and 6 months or early termination Number of cases (frequency) of metabolism syndrome at enrollment with/without the occurrence of myocardial infarction or coronary revascularization At baseline