Plasma Modifications Associated With Rivaroxaban® Treatment for Stroke Prevention

Study Overview
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Brief Summary
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The main objective of this pilot study is to investigate the protein / peptide plasma profiles before and after treatment with a direct anti-Xa (activated Factor 10) in patients with non-valvular atrial fibrillation to better understand the mechanisms of action of these molecules and perform exploratory analyses concerning proteins whose concentrations change after starting treatment.

Official Title
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Evaluation of Plasma Modifications Associated With Rivaroxaban® Treatment for Stroke Prevention in Patients With Atrial Fibrillation

Conditions
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Atrial Fibrillation

Intervention / Treatment
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* Drug: Rivaroxaban


Participation Criteria
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Eligibility Criteria
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Inclusion Criteria: The patient was correctly informed about the study, its implementation, objectives, associated restrictions and patient rights The patient must have given his/her informed and signed consent The patient must be insured or beneficiary of a health insurance plan The patient is available for 1 month of follow-up The patient has non-valvular atrial fibrillation that was diagnosed within the last 3 months. Documentation of atrial fibrillation by a 12-lead ECG, an ECG rhythm strip, atrial fibrillation episode lasting at least 30 seconds. The patient has a CHA2-DS2-VASc score = 1, that is to say the presence of at least one of the following risk factors: (1) congestive heart failure or moderate to severe systolic dysfunction of the left ventricle; (2) history of systolic blood pressure> 160 mmHg; (3) diabetes; (4) history of ischemic stroke or systemic embolism; (5) vascular disease (myocardial infarction, arterial disease); (6) age > 65 years; (7) female. The patient will start Rivaroxaban (Xarelto®) at the Nîmes University Hospital Exclusion Criteria: The patient is participating in another interventional study The patient has participated in another interventional study within the past three months The patient is in an exclusion period determined by a previous study The patient is under judicial protection, under tutorship or curatorship The patient refuses to sign the consent It is impossible to correctly inform the patient The patient is pregnant, parturient, or breastfeeding Presence of a mechanical heart valve or valve disease Patient who recieved another new direct oral anticoagulant other than Xarelto® in the previous three months

Ages Eligible for Study
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Minimum Age: 18 Years

Sexes Eligible for Study
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All

Accepts Healthy Volunteers
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No

Study Plan
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How is the study designed?
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Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| the Study Population<br>The study population consists of patients in the cardiology department at the Nîmes University Hospital with non-valvular atrial fibrillation and who are candidates for treatment with a direct oral anticoagulant: Rivaroxaban (Xarelto®). Patients will be selected according to criteria designed to result in a homogeneous population (associated anticoagulants, etc., see below). For this study, patients must not have had a direct oral anti-Xa (activated Factor 10) in the 6 months preceding enrollment. Intervention: Rivaroxaban | Drug: Rivaroxaban<br>* Patients are observed during their first month of Rivaroxaban (Xarelto®) treatment, which is part of their routine care.<br>* Other names: (Xarelto®);|

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| The percent change in plasma protein/peptide profiles after one month of treatment versus before treatment |  | 1 month (between days 28 to 35) versus baseline (day 0) | 

 Terms related to the study
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Keywords Provided by Centre Hospitalier Valida
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Xarelto®, protein/peptide profiles