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Status:

COMPLETED

Plasma Modifications Associated With Rivaroxaban® Treatment for Stroke Prevention

Lead Sponsor:

Centre Hospitalier Universitaire de Nīmes

Conditions:

Atrial Fibrillation

Eligibility:

All Genders

18+ years

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 atri...

Eligibility Criteria

Inclusion

  • 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

  • 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

Key Trial Info

Start Date :

November 1 2015

Trial Type :

OBSERVATIONAL

Allocation :

ACTUAL

End Date :

January 1 2016

Estimated Enrollment :

5 Patients enrolled

Trial Details

Trial ID

NCT02273700

Start Date

November 1 2015

End Date

January 1 2016

Last Update

August 24 2016

Active Locations (1)

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CHRU de Nîmes - Hôpital Universitaire Carémeau

Nîmes, France, 30029