Plasma Modifications Associated With Rivaroxaban® Treatment for Stroke Prevention "Naco_Nîmes"

Completed

Phase N/A Results N/A

Update History

25 Aug '16
A location was updated in Nîmes Cedex 09.
New
The overall status was removed for CHRU de Nîmes - Hôpital Universitaire Carémeau.
6 Dec '15
A location was updated in Nîmes Cedex 09.
New
The overall status was removed for CHRU de Nîmes - Hôpital Universitaire Carémeau.
23 Oct '15
The Summary of Purpose was updated.
New
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.
Old
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.
The eligibility criteria were updated.
New
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
Old
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