Evaluation of Plasma Modifications Associated With Rivaroxaban® Treatment for Stroke Prevention in Patients With Atrial Fibrillation
试验速览
- 阶段
- 不适用
- 状态
- 已完成
- 发起方
- 入组人数
- 5
- 试验地点
- 1
- 主要终点
- The percent change in plasma protein/peptide profiles after one month of treatment versus before treatment
研究概览
简要总结
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.
研究设计
- 研究类型
- Observational
- 观察模型
- Cohort
- 时间视角
- Prospective
入排标准
- 年龄范围
- 18 Years 至 —（Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •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
排除标准
- •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
研究组 & 干预措施
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
干预措施: Rivaroxaban (Drug)
结局指标
主要结局
The percent change in plasma protein/peptide profiles after one month of treatment versus before treatment
时间窗: 1 month (between days 28 to 35) versus baseline (day 0)
次要结局
未报告次要终点