Clinical trial NCT02975453: Study of Major Cardiovascular Events in Patients With Nonvalvular Atrial Fibrillation Treated With Rivaroxaban
Official title: Study of Risk Factors of Major Cardiovascular Events in Patients With Nonvalvular Atrial Fibrillation Treated With a Direct Oral Anticoagulant (Rivaroxaban)
Study type: OBSERVATIONAL
Overall status: COMPLETED
Conditions: Atrial Fibrillation
Lead sponsor: Bayer
Sponsor class: INDUSTRY
Collaborators: name: Janssen Research & Development, LLC
First posted: 2016-11-29
Enrollment: 1481
Sex: ALL
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Observational model: COHORT
Time perspective: PROSPECTIVE
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

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


Eligibility 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).

Primary outcomes:
measure: 2MACE score
timeFrame: At baseline
measure: Occurrence of MACE to evaluate the performance of the 2MACE index
timeFrame: At 2 years and 6 months or early termination
Secondary outcomes:
measure: Incorporation of additional risk factors to the 2MACE index or replacing some of the existing ones
timeFrame: At baseline
measure: 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
measure: Occurrence of stroke
timeFrame: At baseline, at 1 year, at 2 years, at 2 years and 6 months or early termination
measure: Occurrence of transient ischemic attack (TIA)
timeFrame: At baseline, at 1 year, at 2 years, at 2 years and 6 months or early termination
measure: Occurrence of systemic embolism
timeFrame: At baseline, at 1 year, at 2 years, at 2 years and 6 months or early termination
measure: Thromboembolic risk based on the CHADS2 score
timeFrame: At baseline
measure: Thromboembolic risk based on the CHA2DS2-VASC
timeFrame: At baseline
measure: Number of MACEs occurring during the study
timeFrame: At 1 year, at 2 years, at 2 years and 6 months or early termination
measure: Patients' profile
timeFrame: At baseline
measure: Number of cases (frequency) of metabolism syndrome at enrollment with/without the occurrence of myocardial infarction or coronary revascularization
timeFrame: At baseline
Other outcomes:
Locations:
city: Multiple Locations
country: Spain
Study officials:
affiliation: Bayer
name: Bayer Study Director
role: STUDY_DIRECTOR
References:
citation: 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.