Atrial FibrillationEMIRNCT02975453
Study of Major Cardiovascular Events in Patients With Nonvalvular Atrial Fibrillation Treated With Rivaroxaban
An observational study of Atrial Fibrillation, run by Bayer at 1 site in Spain.
Trial summary
Evaluation of the performance of the 2MACE index in a population of nonvalvular atrial fibrillation (NVAF) patients treated with rivaroxaban in Spain Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- Atrial Fibrillation
- What is being tested?
- Rivaroxaban (Xarelto, BAY59-7939)
- How many people
- 1,481 participants
- Where
- 1 siteSpain
- Study dates
- 5 Dec 2016to 26 Aug 2020
- Phase
- Observational
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 years and older
- All sexes
- No healthy volunteers
- Adult, Older adult
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
Who may be able to join
- 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.
Who cannot join
- 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 locations and contacts
1 site in 1 country.
About this study
Official title: 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
- Conditions
- Atrial Fibrillation
- Being tested
- Rivaroxaban (Xarelto, BAY59-7939)
- Medical subject headings
- Atrial Fibrillation
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Rivaroxaban (Xarelto, BAY59-7939)Drug
As prescribed by the treating physician
| Study group | Role | What they receive |
|---|---|---|
| Rivaroxaban | Non-valvular atrial fibrillation (NVAF) patients treated with rivaroxaban for at least 6 months prior to the study inclusion Receives: Drug: Rivaroxaban (Xarelto, BAY59-7939) |
What is being measured
The primary outcome is the main question the study is designed to answer.
2MACE score
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
Measured: At baseline
Occurrence of MACE to evaluate the performance of the 2MACE index
Percentage of patients with MACE including fatal/nonfatal myocardial infarction, cardiac revascularization and cardiovascular death
Measured: At 2 years and 6 months or early termination
Secondary outcomes (10)
Incorporation of additional risk factors to the 2MACE index or replacing some of the existing ones
Risk factors to the 2MACE index (e.g. body mass index, smoking, drugs use, estimated glomerular filtration rate, structural cardio-pathology)
Measured: At baseline
Occurrence of major cardiovascular events (fatal/nonfatal myocardial infarction, cardiac revascularization and cardiovascular death)
Measured: At baseline, at 1 year, at 2 years, at 2 years and 6 months or early termination
Occurrence of stroke
Measured: At baseline, at 1 year, at 2 years, at 2 years and 6 months or early termination
Occurrence of transient ischemic attack (TIA)
Measured: At baseline, at 1 year, at 2 years, at 2 years and 6 months or early termination
Occurrence of systemic embolism
Measured: At baseline, at 1 year, at 2 years, at 2 years and 6 months or early termination
Thromboembolic risk based on the CHADS2 score
CHADS2: Cardiac Failure, Hypertension, Age, Diabetes, Stroke
Measured: At baseline
Thromboembolic risk based on the CHA2DS2-VASC
CHA2DS2-VASc:Cardiac failure, Hypertension, Age ≥75, Diabetes, Stroke -Vascular disease, Age and Sex category
Measured: At baseline
Number of MACEs occurring during the study
Measured: At 1 year, at 2 years, at 2 years and 6 months or early termination
Patients' profile
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)
Measured: At baseline
Number of cases (frequency) of metabolism syndrome at enrollment with/without the occurrence of myocardial infarction or coronary revascularization
Measured: At baseline
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted29 Nov 2016 (estimated)
- Study start5 Dec 2016
- Primary completion18 Mar 2020
- Study completion26 Aug 2020
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (1)Papers the sponsor has linked to this study.
- Other trials for Atrial FibrillationStudies of the same condition, open and under way.
- More trials run by BayerThe sponsor's other registered studies.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Observational
- Observational model
- Cohort
- Time perspective
- Prospective
- Enrolment
- 1,481 participants (actual)
Sponsor and investigators
- Lead sponsor
- Bayer
- Sponsor type
- Industry (pharma, biotech, devices)
- Collaborators
- Janssen Research & Development, LLC
- Responsible party
- Sponsor
- Investigators
- Bayer Study Director, Study director, Bayer
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT02975453
- Sponsor's protocol ID
- 18884
- Acronym
- EMIR
- Status last verified
- Nov 2023
- First submitted
- 18 Nov 2016
- Last updated
- 7 Nov 2023
- Results posted
- No
- Data monitoring committee
- No
Publications
Rivera-Caravaca JM, Anguita Sanchez M, Sanmartin Fernandez M, Rafols C, Baron-Esquivias G, Arribas Ynsaurriaga F, Freixa-Pamias R, Lekuona Goya I, Vazquez Rodriguez JM, Perez-Cabeza AI, Cosin-Sales J, Urena Montilla I, Alvarez-Vieitez Blanco A, Marin F. Adverse Clinical Outcomes and Associated Predictors in Rivaroxaban-Treated Atrial Fibrillation Patients With Renal Impairment. Am J Cardiol. 2023 Sep 15;203:122-127. doi: 10.1016/j.amjcard.2023.06.105. Epub 2023 Jul 22.
PubMed 37487406
Study at a glance
From the registry record, last updated by the sponsor on 7 Nov 2023. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Study of Risk Factors of Major Cardiovascular Events in Patients With Nonvalvular Atrial Fibrillation Treated With a Direct Oral Anticoagulant (Rivaroxaban)
- ClinicalTrials.gov ID
- NCT02975453
- Acronym / sponsor ID
- EMIR / 18884
- Conditions
- Atrial Fibrillation
- Study type
- Observational
- Recruitment status
- Completed
- Enrolment
- 1,481 participants (actual)
- Lead sponsor
- BayerIndustry (pharma, biotech, devices)
- Collaborators
- Janssen Research & Development, LLC
- Study start
- 5 Dec 2016 (actual)
- Primary completion
- 18 Mar 2020 (actual)
- Study completion
- 26 Aug 2020 (actual)
- First posted
- 29 Nov 2016 (estimated)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
Evaluation of the performance of the 2MACE index in a population of nonvalvular atrial fibrillation (NVAF) patients treated with rivaroxaban in Spain
Study design
- Observational model
- Cohort
- Time perspective
- Prospective
- Number of arms
- 1
| Arm | Type | Receives |
|---|---|---|
| Rivaroxaban | – | Drug: Rivaroxaban (Xarelto, BAY59-7939)Non-valvular atrial fibrillation (NVAF) patients treated with rivaroxaban for at least 6 months prior to the study inclusion |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
- 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
Key inclusion criteria (4 listed)
- 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.
Key exclusion criteria (7 listed)
- 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.
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| Rivaroxaban (Xarelto, BAY59-7939)As prescribed by the treating physician | Drug | Rivaroxaban |
Primary outcome
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
10 secondary outcomes
Incorporation of additional risk factors to the 2MACE index or replacing some of the existing ones
Time frame: 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
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
Thromboembolic risk based on the CHA2DS2-VASC
Time frame: 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
Patients' profile
Time frame: 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
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 7 Nov 2023.
- Background: PubMed 37487406Rivera-Caravaca JM, Anguita Sanchez M, Sanmartin Fernandez M, Rafols C, Baron-Esquivias G, Arribas Ynsaurriaga F, Freixa-Pamias R, Lekuona Goya I, Vazquez Rodriguez JM, Perez-Cabeza AI, Cosin-Sales J, Urena Montilla I, Alvarez-Vieitez Blanco A, Marin F. Adverse Clinical Outcomes and Associated Predictors in Rivaroxaban-Treated Atrial Fibrillation Patients With Renal Impairment. Am J Cardiol. 2023 Sep 15;203:122-127. doi: 10.1016/j.amjcard.2023.06.105. Epub 2023 Jul 22.
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Bayer Study Director study director
Bayer
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
An observational study of Atrial Fibrillation, run by Bayer at 1 site in Spain.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 4 inclusion and 7 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: finished, as of the sponsor's last update on 7 Nov 2023. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in Spain. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
2MACE score (time frame: At baseline). The study lists 2 primary outcomes in all. It is what the study was designed to measure, not a finding.
Where can I read the original study information?
On the ClinicalTrials.gov record for NCT02975453, which also lists 1 linked publication.
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 7 Nov 2023.