Cardiovascular Diseases, Intracerebral Hemorrhage, Ischemic Stroke, Oral Anticoagulation, Vascular Diseases
Conditions
Keywords
Registry of Acute Stroke Under Novel Oral Anticoagulants
Brief summary
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.
Detailed description
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: 1. 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. 2. 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. 3. 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. The principal investigator, Prof. Dr. med. Roland Veltkamp, is affiliated with Imperial College London, UK, and Heidelberg University Hospital, Germany.
Interventions
Observational study without study related intervention.
Sponsors
Bayer Healthcare Pharmaceuticals, Inc./Bayer Schering Pharma
Boehringer Ingelheim
Bristol-Myers Squibb
Daiichi Sankyo
University of Wuerzburg
University Hospital Heidelberg
Study design
Observational model
COHORT
Time perspective
PROSPECTIVE
Eligibility
Sex/Gender
ALL
Age
18 Years to No maximum
Healthy volunteers
No
Inclusion criteria
Ischemic stroke substudy: Inclusion Criteria: * 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
Exclusion criteria
* 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
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| Primary hypothesis (ischemic stroke substudy) | 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) |
| Primary hypothesis (hemorrhagic stroke substudy) | 24 hours | Proportion of relevant secondary hematoma expansion on follow-up neuroimaging (hematoma expansion of \>= 33% or 6 mL) |
Countries
Germany
Outcome results
None listed