Trial Condition(s):
Atrial Fibrillation
Study of major cardiovascular events in patients with nonvalvular atrial fibrillation treated with Rivaroxaban (EMIR)
Bayer Identifier:
18884
ClinicalTrials.gov Identifier:
EudraCT Number:
Not Available
EU CT Number:
Not Available
Study Completed
Trial Purpose
Evaluation of the performance of the 2MACE index in a population of nonvalvular atrial fibrillation (NVAF) patients treated with rivaroxaban in Spain
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).
Trial Summary
Enrollment Goal
1481
Trial Dates
Phase
N/A
Could I receive a placebo?
No
Products
Xarelto (Rivaroxaban, BAY59-7939)
Accepts Healthy Volunteers
No
Where to Participate
Loading...
Locations
| Locations | |
|---|---|
Locations Investigative Site Many Locations, Spain | Contact Us: E-mail: [email protected] Phone: (+) 1-888-8422937 |
Trial Design
Study of risk factors of major cardiovascular events in patients with nonvalvular atrial fibrillation treated with a direct oral anticoagulant (Rivaroxaban)
Trial Type:
Observational
Intervention Type:
Drug
Trial Purpose:
N/A
Allocation:
N/A
Blinding:
N/A
Assignment:
N/A
Trial Arms:
1
Primary Outcome
- 2MACE scoreMACE: Major adverse cardiovascular events. 2MACE: History of Myocardial infarction/ Cardiac revascularization and Metabolic Syndrome, Age >75 years, Congestive heart failure (ejection fraction <40%), Thrombo-EmbolismTimeframe: At baseline
- Occurrence of MACE to evaluate the performance of the 2MACE indexPercentage of patients with MACE including fatal/nonfatal myocardial infarction, cardiac revascularization and cardiovascular deathTimeframe: At 2 years and 6 months or early termination
Secondary Outcome
- Incorporation of additional risk factors to the 2MACE index or replacing some of the existing onesRisk factors to the 2MACE index (e.g. body mass index, smoking, drugs use, estimated glomerular filtration rate, structural cardio-pathology)Timeframe: At baseline
- Occurrence of major cardiovascular events (fatal/nonfatal myocardial infarction, cardiac revascularization and cardiovascular death)Timeframe: At baseline, at 1 year, at 2 years, at 2 years and 6 months or early termination
- Occurrence of strokeTimeframe: At baseline, at 1 year, at 2 years, at 2 years and 6 months or early termination
- Occurrence of transient ischemic attack (TIA)Timeframe: At baseline, at 1 year, at 2 years, at 2 years and 6 months or early termination
- Occurrence of systemic embolismTimeframe: At baseline, at 1 year, at 2 years, at 2 years and 6 months or early termination
- Thromboembolic risk based on the CHADS2 scoreCHADS2: Cardiac Failure, Hypertension, Age, Diabetes, StrokeTimeframe: At baseline
- Thromboembolic risk based on the CHA2DS2-VASCCHA2DS2-VASc:Cardiac failure, Hypertension, Age ≥75, Diabetes, Stroke -Vascular disease, Age and Sex categoryTimeframe: At baseline
- Number of MACEs occurring during the studyTimeframe: At 1 year, at 2 years, at 2 years and 6 months or early termination
- Patients' profileBaseline 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)Timeframe: At baseline
- Number of cases (frequency) of metabolism syndrome at enrollment with/without the occurrence of myocardial infarction or coronary revascularizationTimeframe: At baseline
Additional Information
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