Canadian EdoxAban (Lixiana®) Registry in Patients With ATrial Fibrillation and/or ATrial Flutter With Confirmed ValvUlar HeaRt DiseasE (CAPTURE)
试验速览
- 阶段
- 不适用
- 状态
- 已完成
- 发起方
- 入组人数
- 136
- 试验地点
- 9
- 主要终点
- Reasons for choosing edoxaban and reasons for the dosage
研究概览
简要总结
The objective of this registry is the characterization of patients with atrial fibrillation (AF) and/ or atrial flutter (AFL) with confirmed VHD who are prescribed edoxaban in a real life clinical setting.
详细描述
This is an observational, prospective, multicenter, edoxaban Canadian registry of adults (≥18) diagnosed or confirmed with AF and/or AFL with VHD, within the last 12 months, according to local standard procedures and judged by the investigator to be at risk of stroke and in whom anticoagulation with NOAC is clinically indicated and who are prescribed edoxaban. A total of about 300 patients will be enrolled from approximately 10 sites in Quebec. Patients will be treated according to standard local practices. There is no formal interventions. Treatment decisions are left to the physician's discretion.
Registry data will be collected by the investigator or delegate at baseline, 6, 12 and 24 months and recorded in the electronic Case Report Form (eCRF).
Data available in the patient's file will be collected. The only procedure to be performed in the context of this registry is the completion of questionnaires: the Montreal Cognitive Assessment (MoCA©) test and the Anti-Clot-Treatment Scale (ACTS-Q) questionnaire.
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
- •Male and female patients aged ≥ 18 years at baseline (signing of consent);
- •Willing and able to provide written informed consent;
- •Patient diagnosed or confirmed with AF and/or AFL within the last 12 months of signed consent form;
- •Patient with VHD confirmed by echocardiography within the last 36 months of signed consent form except for mitral stenosis that must be confirmed within the last 12 months;
- •Patient at risk for stroke in whom a long term oral anticoagulation is indicated and who are prescribed edoxaban.
排除标准
- •Patients with AF and/or AFL secondary to reversible cause;
- •Patients with a mechanical heart valve or rheumatic mitral stenosis, or moderate and severe non rheumatic mitral stenosis;
- •Patients planned to have an intervention for valvular heart disease in the next 12 months;
- •Pregnant or breastfeeding women.
- •Short term anticoagulation post cardioversion or ablation.
研究组 & 干预措施
Atrial Fibrillation and/or Atrial Flutter
Subjects taking edoxaban 30mg or 60 mg will be followed for 2 years. Subjects will perform the Montreal Cognitive Assessment (MoCA) Test at baseline and 1-year follow up. They will also answer the Anti-Clot Treatment questionnaire (ACTS-Q) at 1-year.
干预措施: Edoxaban Pill (Drug)
结局指标
主要结局
Reasons for choosing edoxaban and reasons for the dosage
时间窗: 2 years
Physician satisfaction with regards to edoxaban treatment
时间窗: 2 years
Stroke (hemorrhagic stroke, ischemic stroke), transient ischemic attack (TIA) and systemic embolism events (SEE)
时间窗: 2 years
Bleeding (Frequency, Location, Severity, Type of intervention and Outcome)
时间窗: 2 years
Death (CV and non-CV)
时间窗: 2 years
Patient treatment satisfaction using Anti-Clot Treatment Scale (ACTS)
时间窗: 2 years
Cognitive function using the Montreal Cognitive Assessment (MoCA) test
时间窗: 2 years
Percentage of patients on appropriate dosage of edoxaban (60 mg and 30 mg if dose reduction criteria)
时间窗: 2 years
Adverse events (AEs) and serious adverse events (SAEs) related to edoxaban
时间窗: 2 years
Characterization of patients with diagnosed or confirmed atrial fibrillation (AF) and/or atrial flutter (AFL) with valvular heart disease (VHD), within the last 12 months
时间窗: 2 years
Compliance of subjects to edoxaban treatment
时间窗: 2 years
次要结局
未报告次要终点