Registry of Acute Stroke Under Novel Oral Anticoagulants - Prime

Study Overview
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Brief Summary
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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
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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. The principal investigator, Prof. Dr. med. Roland Veltkamp, is affiliated with Imperial College London, UK, and Heidelberg University Hospital, Germany.

Official Title
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Registry of Acute Stroke Under Novel Oral Anticoagulants - Prime

Conditions
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Ischemic Stroke, Intracerebral Hemorrhage, Oral Anticoagulation, Cardiovascular Diseases, Vascular Diseases

Intervention / Treatment
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* Other: not applicable (observational study)


Participation Criteria
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Eligibility Criteria
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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 Exclusion Criteria: No informed consent Symptom-onset > 24 h

Ages Eligible for Study
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Minimum Age: 18 Years

Sexes Eligible for Study
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All

Accepts Healthy Volunteers
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No

Study Plan
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How is the study designed?
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Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| NOAC<br>Ischemic stroke substudy: inclusion of 1000 patients under treatment with non-vitamin K antagonist oral anticoagulants (NOACs). Hemorrhagic stroke substudy: inclusion of 334 patients under treatment with non-vitamin K antagonist oral anticoagulants (NOACs). | Other: not applicable (observational study)<br>* Observational study without study related intervention.<br>|
| VKA<br>Ischemic stroke substudy: inclusion of 1000 patients under treatment with vitamin K antagonists (VKA). Hemorrhagic stroke substudy: inclusion of 333 patients under treatment with vitamin K antagonists (VKA) | Other: not applicable (observational study)<br>* Observational study without study related intervention.<br>|
| Without OAC<br>Ischemic stroke substudy: inclusion of 1000 patients without oral anticoagulation. Hemorrhagic stroke substudy: inclusion of 333 patients without oral anticoagulation. | Other: not applicable (observational study)<br>* Observational study without study related intervention.<br>|

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Primary hypothesis (ischemic stroke substudy) | Intracerebral hemorrhage complications (i.e. sICH, according to NINDS and SITS-MOST) | Participants will be followed for the duration of hospital stay, an expected average of less than 2 weeks | 
| Primary hypothesis (hemorrhagic stroke substudy) | Proportion of relevant secondary hematoma expansion on follow-up neuroimaging (hematoma expansion of >= 33% or 6 mL) | 24 hours | 

 Terms related to the study
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Keywords Provided by Centre Hospitalier Valida
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Registry of Acute Stroke Under Novel Oral Anticoagulants