Registry of Acute Stroke Under Novel Oral Anticoagulants - Prime
试验速览
- 阶段
- 不适用
- 状态
- 已完成
- 入组人数
- 3,832
- 试验地点
- 1
- 主要终点
- Primary hypothesis (hemorrhagic stroke substudy)
研究概览
简要总结
The Registry of Acute Stroke Under Novel Oral Anticoagulants-Prime (RASUNOA-Prime), an investigator-initiated study, is a German multicenter, prospective, observational registry. It is performed at about 50 certified stroke-units and supported by an unrestricted grant from different pharmaceutical companies to the Heidelberg University Hospital. RASUNOA-Prime is designed to assess the emergency management of acute ischemic and hemorrhagic stroke patients with atrial fibrillation (AF) under different anticoagulation schemes pre stroke: Non-vitamin K antagonist oral anticoagulants (NOAC), Vitamin K antagonists (VKA), and no anticoagulation.
详细描述
The main purpose of this observational cohort study is to assess routine emergency management of acute stroke patients with AF under different anticoagulation schemes before the index stroke.
The investigators will address the following aims and objectives:
- Describing emergency management of stroke patients (IS and ICH) with AF in clinical routine including early diagnostic, therapeutic and preventive procedures and assessing variations in emergency management of patients with AF by anticoagulation schemes pre stroke.
- Identifying variations in risk of early complications (e.g. symptomatic secondary intracerebral haemorrhage in ischemic stroke patients) with AF by different anticoagulation schemes pre stroke.
- Determining factors influencing outcome of stroke patients with AF at three months and clarifying the potential influence of different anticoagulation schemes pre stroke.
The registry consists of 2 separate substudies that cover two different patient cohorts: ischemic stroke and intracerebral hemorrhage.
The study will collect information from prospectively enrolling Neurology departments with certified stroke units across Germany.
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
- •Age >= 18 years
- •Informed consent
- •Acute ischemic stroke with either symptoms lasting ≥ 24h or evidence of infarction in brain imaging
- •Anticoagulation with NOAC
- •Anticoagulation with VKA
- •No anticoagulation
- •Previous/present atrial fibrillation
排除标准
- •No informed consent
- •Symptom-onset > 24 h
- •Hemorrhagic stroke substudy:
- •Inclusion Criteria:
- •Age >= 18 years
- •Acute primary intracerebral hemorrhage
- •- a) Anticoagulation with NOAC
- •- b) Anticoagulation with VKA
- •- c) No anticoagulation
- •Previous/present atrial fibrillation
- •Exclusion Criteria:
- •No informed consent
- •Symptom-onset > 24 h
结局指标
主要结局
Primary hypothesis (hemorrhagic stroke substudy)
时间窗: 24 hours
Proportion of relevant secondary hematoma expansion on follow-up neuroimaging (hematoma expansion of \>= 33% or 6 mL)
Primary hypothesis (ischemic stroke substudy)
时间窗: Participants will be followed for the duration of hospital stay, an expected average of less than 2 weeks"
Intracerebral hemorrhage complications (i.e. sICH, according to NINDS and SITS-MOST)
次要结局
未报告次要终点
研究者
Prof. Roland Veltkamp
Principal Investigator
University Hospital Heidelberg