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

November 3, 2023 updated by: Bayer

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

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

Study Overview

Status

Completed

Conditions

Intervention / Treatment

Study Type

Observational

Enrollment (Actual)

1481

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Locations

  • Spain
      • Multiple Locations, Spain

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

18 years and older (Adult, Older Adult)

Accepts Healthy Volunteers

No

Sampling Method

Non-Probability Sample

Study Population

Adult patients diagnosed with non-valvular atrial fibrillation who are under rivaroxaban treatment and that attend the Cardiology Units at Spanish hospitals and private clinics

Description

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).

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

Cohorts and Interventions

Group / Cohort
Intervention / Treatment
Rivaroxaban
Non-valvular atrial fibrillation (NVAF) patients treated with rivaroxaban for at least 6 months prior to the study inclusion
Drug: Rivaroxaban (Xarelto, BAY59-7939)
As prescribed by the treating physician

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Measure Description
Time Frame
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
At baseline
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
At 2 years and 6 months or early termination

Secondary Outcome Measures

Outcome Measure
Measure Description
Time Frame
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)
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
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
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
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
At baseline, at 1 year, at 2 years, at 2 years and 6 months or early termination
Thromboembolic risk based on the CHADS2 score
Time Frame: At baseline
CHADS2: Cardiac Failure, Hypertension, Age, Diabetes, Stroke
At baseline
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
At baseline
Number of MACEs occurring during the study
Time Frame: At 1 year, at 2 years, at 2 years and 6 months or early termination
At 1 year, at 2 years, at 2 years and 6 months or early termination
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)
At baseline
Number of cases (frequency) of metabolism syndrome at enrollment with/without the occurrence of myocardial infarction or coronary revascularization
Time Frame: At baseline
At baseline

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

Bayer

Collaborators

Janssen Research & Development, LLC

Investigators

  • Study Director: Bayer Study Director, Bayer

Publications and helpful links

The person responsible for entering information about the study voluntarily provides these publications. These may be about anything related to the study.

General Publications

Helpful Links

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start (Actual)

December 5, 2016

Primary Completion (Actual)

March 18, 2020

Study Completion (Actual)

August 26, 2020

Study Registration Dates

First Submitted

November 18, 2016

First Submitted That Met QC Criteria

November 23, 2016

First Posted (Estimated)

November 29, 2016

Study Record Updates

Last Update Posted (Actual)

November 7, 2023

Last Update Submitted That Met QC Criteria

November 3, 2023

Last Verified

November 1, 2023

More Information

Terms related to this study

Additional Relevant MeSH Terms

Other Study ID Numbers

  • 18884

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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