Study of Major Cardiovascular Events in Patients With Nonvalvular Atrial Fibrillation Treated Wit… (NCT02975453) | Clinical Trial Compass
CompletedNot Applicable
Study of Major Cardiovascular Events in Patients With Nonvalvular Atrial Fibrillation Treated With Rivaroxaban
Spain1,481 participantsStarted 2016-12-05
Plain-language summary
Evaluation of the performance of the 2MACE index in a population of nonvalvular atrial fibrillation (NVAF) patients treated with rivaroxaban in Spain
Who can participate
Age range18 Years
SexALL
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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).
What they're measuring
1
2MACE score
Timeframe: At baseline
2
Occurrence of MACE to evaluate the performance of the 2MACE index
Timeframe: At 2 years and 6 months or early termination