Plasma Modifications Associated With Rivaroxaban® Treatment for Stroke Prevention

Completed

• Conditions: Atrial Fibrillation
• Interventions: Drug: Rivaroxaban

• Registration Number: NCT02273700
• Lead Sponsor: 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.

Detailed Description

Not available

Study Timeline

• Study First Submitted: 2014-10-22
• Study First Submitted QC: 2014-10-22
• Study First Posted: 2014-10-24
• Study Start: 2015-11
• Primary Completion: 2016-01
• Study Completion: 2016-01
• Status Verified: 2016-08
• Last Update Submitted: 2016-08-23
• Last Update Posted: 2016-08-24

Recruitment & Eligibility

• Status: COMPLETED
• Sex: All
• Target Recruitment: 5

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

Study & Design

• Study Type: OBSERVATIONAL
• Study Design: Not specified

Arm && Interventions

Group	Intervention	Description
the Study Population	Rivaroxaban	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

Primary Outcome Measures

Name	Time	Method
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)

Trial Locations

Locations (1)

CHRU de Nîmes - Hôpital Universitaire Carémeau; 🇫🇷 Nîmes Cedex 09, France