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Completed

NCT Number: NCT02975453

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

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

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Key information

Conditions

Atrial Fibrillation Arrhythmias, Cardiac Cardiovascular Diseases Heart Diseases Pathologic Processes Pathological Conditions, Signs and Symptoms

Age range

18 year and older

Sex eligibility

All sexes

Study type

Observational

Primary location

Multiple Locations, Spain

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

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).

Treatment and study plan

Rivaroxaban (Xarelto, BAY59-7939)

Drug

As prescribed by the treating physician

Primary outcomes

  1. 2MACE score

    Time frame: 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

  2. Occurrence of MACE to evaluate the performance of the 2MACE index

    Time frame: 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 outcomes

  1. Incorporation of additional risk factors to the 2MACE index or replacing some of the existing ones

    Time frame: At baseline

    Risk factors to the 2MACE index (e.g. body mass index, smoking, drugs use, estimated glomerular filtration rate, structural cardio-pathology)

  2. 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

  3. Occurrence of stroke

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

  4. 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

  5. Occurrence of systemic embolism

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

  6. Thromboembolic risk based on the CHADS2 score

    Time frame: At baseline

    CHADS2: Cardiac Failure, Hypertension, Age, Diabetes, Stroke

  7. Thromboembolic risk based on the CHA2DS2-VASC

    Time frame: At baseline

    CHA2DS2-VASc:Cardiac failure, Hypertension, Age ≥75, Diabetes, Stroke -Vascular disease, Age and Sex category

  8. Number of MACEs occurring during the study

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

  9. Patients' profile

    Time frame: 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)

  10. Number of cases (frequency) of metabolism syndrome at enrollment with/without the occurrence of myocardial infarction or coronary revascularization

    Time frame: At baseline

Sponsors and collaborators

Lead sponsor

Bayer

Industry

Collaborators

  • Janssen Research & Development, LLC

Registry information

Official study title

Study of Risk Factors of Major Cardiovascular Events in Patients With Nonvalvular Atrial Fibrillation Treated With a Direct Oral Anticoagulant (Rivaroxaban)

Acronym: EMIR

Important dates

Study start
2016
Primary completion
2020
Study completion
2020
First posted
Nov 29, 2016
Registry last updated
Nov 7, 2023

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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