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OpenTrials
Completed

NCT Number: NCT02273700

Plasma Modifications Associated With Rivaroxaban® Treatment for Stroke Prevention

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.

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Key information

Age range

18 year and older

Sex eligibility

All sexes

Study type

Observational

Primary location

CHRU de Nîmes - Hôpital Universitaire Carémeau

Nîmes, 30029, France

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

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

Treatment and study plan

Rivaroxaban

Drug

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

Other names: (Xarelto®)

Primary outcomes

  1. The percent change in plasma protein/peptide profiles after one month of treatment versus before treatment

    Time frame: 1 month (between days 28 to 35) versus baseline (day 0)

Sponsors and collaborators

Lead sponsor

Centre Hospitalier Universitaire de Nīmes

Other

Registry information

Official study title

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

Acronym: Naco_Nîmes

Important dates

Study start
2015
Primary completion
2016
Study completion
2016
First posted
Oct 24, 2014
Registry last updated
Aug 24, 2016

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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