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Plasma Modifications Associated With Rivaroxaban® Treatment for Stroke Prevention (Naco_Nîmes)

The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details.
 
ClinicalTrials.gov Identifier: NCT02273700
Recruitment Status : Completed
First Posted : October 24, 2014
Last Update Posted : August 24, 2016
Sponsor:
Information provided by (Responsible Party):
Centre Hospitalier Universitaire de Nīmes

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.

Condition or disease Intervention/treatment
Atrial Fibrillation Drug: Rivaroxaban

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Study Type : Observational
Actual Enrollment : 5 participants
Observational Model: Cohort
Time Perspective: Prospective
Official Title: Evaluation of Plasma Modifications Associated With Rivaroxaban® Treatment for Stroke Prevention in Patients With Atrial Fibrillation
Study Start Date : November 2015
Actual Primary Completion Date : January 2016
Actual Study Completion Date : January 2016

Resource links provided by the National Library of Medicine

Drug Information available for: Rivaroxaban

Group/Cohort Intervention/treatment
the Study 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.

Intervention: Rivaroxaban

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




Primary Outcome Measures :
  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) ]


Information from the National Library of Medicine

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Ages Eligible for Study:   18 Years and older   (Adult, Older Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No
Sampling Method:   Non-Probability Sample
Study 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.
Criteria

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

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT02273700


Locations
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France
CHRU de Nîmes - Hôpital Universitaire Carémeau
Nîmes Cedex 09, France, 30029
Sponsors and Collaborators
Centre Hospitalier Universitaire de Nīmes
Investigators
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Principal Investigator: Géraldine Lavigne-Lissalde, MD Centre Hospitalier Universitaire de Nîmes

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Responsible Party: Centre Hospitalier Universitaire de Nīmes
ClinicalTrials.gov Identifier: NCT02273700    
Other Study ID Numbers: LOCAL/2014/GL-01
2014-A00516-41 ( Other Identifier: RCB number )
First Posted: October 24, 2014    Key Record Dates
Last Update Posted: August 24, 2016
Last Verified: August 2016
Keywords provided by Centre Hospitalier Universitaire de Nīmes:
Xarelto®
protein/peptide profiles
Additional relevant MeSH terms:
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Atrial Fibrillation
Arrhythmias, Cardiac
Heart Diseases
Cardiovascular Diseases
Pathologic Processes
Rivaroxaban
Factor Xa Inhibitors
Antithrombins
Serine Proteinase Inhibitors
Protease Inhibitors
Enzyme Inhibitors
Molecular Mechanisms of Pharmacological Action
Anticoagulants