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

Atrial Fibrillation Clinical Trial

— EMIR  

Official title:

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

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT02975453
• Other study ID #: 18884
• Status: Completed
• Start date: December 5, 2016
• Est. completion date: August 26, 2020

Study information

• Verified date: November 2023
• Source: Bayer
• Contact: n/a
• Is FDA regulated: No
• Study type: Observational

Clinical Trial Summary

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

Recruitment information / eligibility

• Status: Completed
• Enrollment: 1481
• Est. completion date: August 26, 2020
• Est. primary completion date: March 18, 2020
• Accepts healthy volunteers: No
• Gender: All
• Age group: 18 Years and older

Eligibility

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).

Related Conditions & MeSH terms

• Atrial Fibrillation

Intervention

Drug:
• Rivaroxaban (Xarelto, BAY59-7939)
As prescribed by the treating physician

Locations

Country	Name	City	State
n/a

Sponsors (2)

Lead Sponsor	Collaborator
Bayer	Janssen Research & Development, LLC

Country where clinical trial is conducted

Spain, 

References & Publications (1)

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. — View Citation

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	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	At baseline
Primary	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	At 2 years and 6 months or early termination
Secondary	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)	At baseline
Secondary	Occurrence of major cardiovascular events (fatal/nonfatal myocardial infarction, cardiac revascularization and cardiovascular death)		At baseline, at 1 year, at 2 years, at 2 years and 6 months or early termination
Secondary	Occurrence of stroke		At baseline, at 1 year, at 2 years, at 2 years and 6 months or early termination
Secondary	Occurrence of transient ischemic attack (TIA)		At baseline, at 1 year, at 2 years, at 2 years and 6 months or early termination
Secondary	Occurrence of systemic embolism		At baseline, at 1 year, at 2 years, at 2 years and 6 months or early termination
Secondary	Thromboembolic risk based on the CHADS2 score	CHADS2: Cardiac Failure, Hypertension, Age, Diabetes, Stroke	At baseline
Secondary	Thromboembolic risk based on the CHA2DS2-VASC	CHA2DS2-VASc:Cardiac failure, Hypertension, Age =75, Diabetes, Stroke -Vascular disease, Age and Sex category	At baseline
Secondary	Number of MACEs occurring during the study		At 1 year, at 2 years, at 2 years and 6 months or early termination
Secondary	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)	At baseline
Secondary	Number of cases (frequency) of metabolism syndrome at enrollment with/without the occurrence of myocardial infarction or coronary revascularization		At baseline

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