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

Bayer

Status: Completed

Conditions: Atrial Fibrillation

Treatments: Drug: Rivaroxaban (Xarelto, BAY59-7939)

Study type: Observational

Funder types: Industry

Identifiers

NCT02975453

18884

Details and patient eligibility

About

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

Enrollment: 1,481 patients

Sex: All

Ages: 18+ years old

Volunteers: No Healthy Volunteers

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).

Trial design

1,481 participants in 1 patient group

Rivaroxaban

Description:

Non-valvular atrial fibrillation (NVAF) patients treated with rivaroxaban for at least 6 months prior to the study inclusion

Treatment:

Drug: Rivaroxaban (Xarelto, BAY59-7939)