Eligibility Module
The Eligibility Module contains detailed information about who can participate in the clinical trial. This includes eligibility criteria, age restrictions, gender requirements, healthy volunteer status, and study population descriptions, helping researchers understand who is eligible to participate in the study.
Eligibility Module path is as follows:
Study -> Protocol Section -> Eligibility Module
Eligibility Module
Ignite Creation Date:
2025-12-26 @ 12:18 PM
Ignite Modification Date:
2025-12-26 @ 12:18 PM
NCT ID:
NCT02273700
Eligibility 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
Healthy Volunteers:
False
Sex:
ALL
Minimum Age:
18 Years
Study:
NCT02273700
Study Brief:
Protocol Section:
NCT02273700