RASUNOA-Prime: Registry of Acute Stroke Under Novel Oral Anticoagulants - Prime
Study Details
Study Description
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.
| Condition or Disease | Intervention/Treatment | Phase |
|---|---|---|
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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:
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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.
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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.
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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.
Study Design
Arms and Interventions
| Arm | Intervention/Treatment |
|---|---|
| NOAC 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)
Observational study without study related intervention.
|
| VKA 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)
Observational study without study related intervention.
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| Without OAC 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)
Observational study without study related intervention.
|
Outcome Measures
Primary Outcome Measures
- 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)
Eligibility Criteria
Criteria
Ischemic stroke substudy:
Inclusion Criteria:
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Age >= 18 years
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Informed consent
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Acute ischemic stroke with either symptoms lasting ≥ 24h or evidence of infarction in brain imaging
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Anticoagulation with NOAC
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Anticoagulation with VKA
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No anticoagulation
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Previous/present atrial fibrillation
Exclusion Criteria:
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No informed consent
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Symptom-onset > 24 h
Hemorrhagic stroke substudy:
Inclusion Criteria:
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Age >= 18 years
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Acute primary intracerebral hemorrhage
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- Anticoagulation with NOAC
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- Anticoagulation with VKA
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- No anticoagulation
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Previous/present atrial fibrillation
Exclusion Criteria:
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No informed consent
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Symptom-onset > 24 h
Contacts and Locations
Locations
| Site | City | State | Country | Postal Code | |
|---|---|---|---|---|---|
| 1 | University Hospital Heidelberg | Heidelberg | Germany | 69120 |
Sponsors and Collaborators
- University Hospital Heidelberg
- Bayer Healthcare Pharmaceuticals, Inc./Bayer Schering Pharma
- Boehringer Ingelheim
- Bristol-Myers Squibb
- Daiichi Sankyo, Inc.
- University of Wuerzburg
Investigators
- Principal Investigator: Roland Veltkamp, Prof. Dr. med., Heidelberg University Hospital, Department of Neurology, Heidelberg, Germany; Department of Stroke Medicine, Imperial College London, London, United Kingdom.
Study Documents (Full-Text)
None provided.More Information
Additional Information:
Publications
- RASUNOA-Prime