Plasma Modifications Associated With Rivaroxaban® Treatment for Stroke Prevention "Naco_Nîmes"

Completed

Phase N/A Results N/A

Trial Description

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.

Conditions

Interventions

  • Rivaroxaban Drug
    Intervention Desc: Patients are observed during their first month of Rivaroxaban (Xarelto®) treatment, which is part of their routine care.
    ARM 1: Kind: Experimental
    Label: the Study Population
    Description: 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

Trial Design

  • Observation: Cohort
  • Perspective: Prospective
  • Sampling: Non-Probability Sample

Trial Population

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.

Outcomes

Type Measure Time Frame Safety Issue
Primary 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) No

Sponsors