Skip to content

Plasma Modifications Associated With Rivaroxaban® Treatment for Stroke Prevention

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

Status
Completed
Phases
Unknown
Study type
Observational
Source
ClinicalTrials.gov
Registry ID
NCT02273700
Acronym
Naco_Nîmes
Enrollment
5
Registered
2014-10-24
Start date
2015-11-30
Completion date
2016-01-31
Last updated
2016-08-24

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

Atrial Fibrillation

Keywords

Xarelto®, protein/peptide profiles

Brief summary

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.

Interventions

DRUGRivaroxaban

Patients are observed during their first month of Rivaroxaban (Xarelto®) treatment, which is part of their routine care.

Sponsors

Centre Hospitalier Universitaire de Nīmes
Lead SponsorOTHER

Study design

Observational model
COHORT
Time perspective
PROSPECTIVE

Eligibility

Sex/Gender
ALL
Age
18 Years to No maximum
Healthy volunteers
No

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

Design outcomes

Primary

MeasureTime frame
The percent change in plasma protein/peptide profiles after one month of treatment versus before treatment1 month (between days 28 to 35) versus baseline (day 0)

Countries

France

Outcome results

None listed

Source: ClinicalTrials.gov · Data processed: Feb 4, 2026