Study of Major Cardiovascular Events in Patients With Nonvalvular Atrial Fibrillation Treated With Rivaroxaban (EMIR)
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ClinicalTrials.gov Identifier: NCT02975453 |
Recruitment Status :
Active, not recruiting
First Posted : November 29, 2016
Last Update Posted : January 23, 2019
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Condition or disease | Intervention/treatment |
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Atrial Fibrillation | Drug: Rivaroxaban (Xarelto, BAY59-7939) |
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 |

Group/Cohort | Intervention/treatment |
---|---|
Rivaroxaban
Non-valvular atrial fibrillation (NVAF) patients treated with rivaroxaban for at least 6 months prior to the study inclusion
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Drug: Rivaroxaban (Xarelto, BAY59-7939)
As prescribed by the treating physician |
- 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
- 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
- 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)
- 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 [ Time Frame: At baseline ]CHADS2: Cardiac Failure, Hypertension, Age, Diabetes, Stroke
- 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
- Number of MACEs occurring during the study [ Time Frame: 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)
- Number of cases (frequency) of metabolism syndrome at enrollment with/without the occurrence of myocardial infarction or coronary revascularization [ Time Frame: At baseline ]

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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 |
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).

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.
Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT02975453
Spain | |
Multiple Locations, Spain |
Study Director: | Bayer Study Director | Bayer |
Additional Information:


Responsible Party: | Bayer |
ClinicalTrials.gov Identifier: | NCT02975453 History of Changes |
Other Study ID Numbers: |
18884 |
First Posted: | November 29, 2016 Key Record Dates |
Last Update Posted: | January 23, 2019 |
Last Verified: | January 2019 |
Additional relevant MeSH terms:
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 |