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

• Sponsor: Bayer
• Collaborator: Janssen Research & Development, LLC
• Information provided by (Responsible Party): Bayer

Study Description

Brief Summary:

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

Condition or disease	Intervention/treatment
Atrial Fibrillation	Drug: Rivaroxaban (Xarelto, BAY59-7939)

Study Design

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Study Type :	Observational
Actual Enrollment :	1463 participants
Observational Model:	Cohort
Time Perspective:	Prospective
Official Title:	Study of Risk Factors of Major Cardiovascular Events in Patients With Nonvalvular Atrial Fibrillation Treated With a Direct Oral Anticoagulant (Rivaroxaban)
Actual Study Start Date :	December 5, 2016
Estimated Primary Completion Date :	December 15, 2019
Estimated Study Completion Date :	February 28, 2020

Groups and Cohorts

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

Outcome Measures

Primary Outcome Measures :

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 Outcome Measures :

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 ]

Eligibility Criteria

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Ages Eligible for Study:	18 Years and older (Adult, Older Adult)
Sexes Eligible for Study:	All
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

Criteria

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).

Contacts and Locations

Locations

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Spain
Multiple Locations, Spain

Sponsors and Collaborators

Bayer

Janssen Research & Development, LLC

Investigators

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Study Director:	Bayer Study Director	Bayer

More Information

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Responsible Party:	Bayer
ClinicalTrials.gov Identifier:	NCT02975453 History of Changes
Other Study ID Numbers:	18884
First Posted:	November 29, 2016
Last Update Posted:	May 24, 2019
Last Verified:	May 2019

Additional relevant MeSH terms:

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Atrial Fibrillation; Arrhythmias, Cardiac; Heart Diseases; Cardiovascular Diseases; Pathologic Processes; Rivaroxaban; Factor Xa Inhibitors	Antithrombins; Serine Proteinase Inhibitors; Protease Inhibitors; Enzyme Inhibitors; Molecular Mechanisms of Pharmacological Action; Anticoagulants