New Oral Anticoagulants in Stroke Patients-Long Term Prevention of Recurrent Stroke in Patients With Atrial Fibrillation- a National Prospective Registry (NOACISP Long Term)
试验速览
- 阶段
- 不适用
- 状态
- 已完成
- 发起方
- 入组人数
- 1,023
- 试验地点
- 2
- 主要终点
- Change in anticoagulation (NOAC and VKA) treatment
研究概览
简要总结
Registry to explore characteristics, use and management of new oral anticoagulants (NOAC) and vitamin K antagonists (VKA) treatment among patients with atrial fibrillation (AF) and recent cerebrovascular disease in a "real-world" setting at a stroke centre.
详细描述
Registry to explore characteristics, use and management of new oral anticoagulants (NOAC) and vitamin K antagonists (VKA) treatment among patients with atrial fibrillation (AF) and recent cerebrovascular disease in a "real-world" setting at a stroke centre. Special interest is payed to conditions not or only in part investigated in the large randomised controlled Trials (RCT) and that are specific to patients with cerebrovascular disease. This includes early start of NOAC treatment after recent stroke, very old patients, multimorbidity, patients with a history of intracranial haemorrhage (ICH) and patient satisfaction and preferences with VKA/NOACS.
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
- •signed informed consent form (ICF)
- •existing or newly diagnosed AF
- •recent (< 3 month) stroke (ischemic or haemorrhagic) or TIA (=index event)
- •treatment with NOACs or VKAs is continued, changed or initiated for prevention of ischemic events
排除标准
- •patients not able or unwilling to sign ICF
- •patient is, in the opinion of the investigator, unlikely to comply with the scheduled follow-up visits or is unsuitable for any other reason
- •patients who will not be anticoagulated
结局指标
主要结局
Change in anticoagulation (NOAC and VKA) treatment
时间窗: time from index event (= cerebrovascular event) to Follow- up assessments at 3-, 6-, 12- and 24 months after index event
assessment of details of NOAC or VKA application (start, pause, dosage)
次要结局
- Co-morbidities(time from index event (= cerebrovascular event) to Follow- up assessments at 3-, 6-, 12- and 24 months after index event)
- Change in anticoagulant treatment(time from index event (= cerebrovascular event) to Follow- up assessments at 3-, 6-, 12- and 24 months after index event)
- Change in modified Rankin Scale (mRS)(time from index event (= cerebrovascular event) to Follow- up assessments at 3-, 6-, 12- and 24 months after index event)
- Change in glomerular filtration rate (GFR)(time from index event (= cerebrovascular event) to Follow- up assessments at 3-, 6-, 12- and 24 months after index event)
- Drug adherence for anticoagulation (VKA) treatment(time from index event (= cerebrovascular event) to Follow- up assessments at 3-, 6-, 12- and 24 months after index event)
- Drug adherence for anticoagulation (NOAC) treatment(time from index event (= cerebrovascular event) to Follow- up assessments at 3-, 6-, 12- and 24 months after index event)
- Recording of Adverse Events (AE)(time from index event (= cerebrovascular event) to Follow- up assessments at 3-, 6-, 12- and 24 months after index event)