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

Bayer1,481 enrolled

Overview

Evaluation of the performance of the 2MACE index in a population of nonvalvular atrial fibrillation (NVAF) patients treated with rivaroxaban in Spain

Study Type

OBSERVATIONAL

Enrollment

1,481

Conditions

Atrial Fibrillation

Interventions

Rivaroxaban (Xarelto, BAY59-7939)DRUG

As prescribed by the treating physician

Eligibility

Sex: ALLMin age: 18 Years

Medical Language ↔ Plain English

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).

Locations (1)

Unnamed facility

Multiple Locations, Spain

Outcomes

Primary Outcomes

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

Time frame: 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

Time frame: At 2 years and 6 months or early termination

Secondary Outcomes

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)

Time frame: At baseline

Occurrence of major cardiovascular events (fatal/nonfatal myocardial infarction, cardiac revascularization and cardiovascular death)

Time frame: At baseline, at 1 year, at 2 years, at 2 years and 6 months or early termination

Occurrence of stroke

Time frame: At baseline, at 1 year, at 2 years, at 2 years and 6 months or early termination

Occurrence of transient ischemic attack (TIA)

Time frame: At baseline, at 1 year, at 2 years, at 2 years and 6 months or early termination

Occurrence of systemic embolism

Time frame: At baseline, at 1 year, at 2 years, at 2 years and 6 months or early termination

Thromboembolic risk based on the CHADS2 score

Data from ClinicalTrials.gov

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