Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
| Name | Class |
|---|---|
| Bayer Healthcare Pharmaceuticals, Inc./Bayer Schering Pharma | INDUSTRY |
| Boehringer Ingelheim | INDUSTRY |
| Bristol-Myers Squibb | INDUSTRY |
| Daiichi Sankyo |
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
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.
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:
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.
Not provided
Not provided
Not provided
Not provided
Not provided
| Label | Type | Description | Intervention Names |
|---|---|---|---|
| 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). |
| |
| 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) |
| |
| Without OAC | Ischemic stroke substudy: inclusion of 1000 patients without oral anticoagulation. Hemorrhagic stroke substudy: inclusion of 333 patients without oral anticoagulation. |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| not applicable (observational study) | Other | Observational study without study related intervention. |
|
| 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 |
Not provided
Not provided
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
Previous/present atrial fibrillation
Exclusion Criteria:
Hemorrhagic stroke substudy:
Inclusion Criteria:
Exclusion Criteria:
Not provided
Not provided
Not provided
Acute stroke patients with atrial fibrillation (AF) under different anticoagulation schemes pre stroke [Non-vitamin K antagonists oral anticoagulants (NOAC, also referred to as novel or new oral anticoagulants), Vitamin K antagonists (VKA), and no oral anticoagulation. According to the type of stroke, patients will be enrolled in the ischemic or hemorrhagic stroke substudy.
NOTE: As of July 2019, enrollment in the ischemic stroke substudy was terminated due to achievement of the targeted enrolling numbers.
NOTE: As of April 2021, enrollment in the intracerebral hemorrhage substudy was terminated due to achievement of the targeted enrolling numbers.](streamdown:incomplete-link)
Not provided
| Name | Affiliation | Role |
|---|---|---|
| Roland Veltkamp, Prof. Dr. med. | Heidelberg University Hospital, Department of Neurology, Heidelberg, Germany; Department of Stroke Medicine, Imperial College London, London, United Kingdom. | Principal Investigator |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| University Hospital Heidelberg | Heidelberg | 69120 | Germany |
| PubMed Identifier | Type | Citation | Retractions |
|---|---|---|---|
| 31259266 | Background | Haas K, Purrucker JC, Rizos T, Heuschmann PU, Veltkamp R. Rationale and design of the Registry of Acute Stroke Under Novel Oral Anticoagulants-prime (RASUNOA-prime). Eur Stroke J. 2019 Jun;4(2):181-188. doi: 10.1177/2396987318812644. Epub 2018 Dec 17. | |
| 42087546 | Derived | Veltkamp AW, Kinzler D, Hellwig B, Heeger A, Husing A, Heuschmann PU, Purrucker JC, Veltkamp R; RASUNOA-Prime Investigators. Prevalence and Association of Atherosclerosis to Ischemic Stroke in Patients With Atrial Fibrillation on Anticoagulation. Stroke. 2026 Jun;57(6):1717-1726. doi: 10.1161/STROKEAHA.126.055284. Epub 2026 May 5. |
Not provided
Not provided
Not provided
| ID | Term |
|---|---|
| D000083242 | Ischemic Stroke |
| D002543 | Cerebral Hemorrhage |
| D002318 | Cardiovascular Diseases |
| D014652 | Vascular Diseases |
| ID | Term |
|---|---|
| D020521 | Stroke |
| D002561 | Cerebrovascular Disorders |
| D001927 | Brain Diseases |
| D002493 | Central Nervous System Diseases |
Not provided
Not provided
| ID | Term |
|---|---|
| D019370 | Observation |
| ID | Term |
|---|---|
| D008722 | Methods |
| D008919 | Investigative Techniques |
Not provided
Not provided
| INDUSTRY |
| University of Wuerzburg | OTHER |
Not provided
Not provided
Not provided
| 41749338 | Derived | Purrucker JC, Haas K, Sieber M, Rucker V, Malzahn U, Haeusler KG, Nolte CH, Gabriel MM, Schiefer J, Poli S, Michalski D, Soda H, Royl G, Meyne J, Nabavi DG, Mosimann P, Heeger A, Kinzler D, Muller P, Rappard P, Rizos T, Heuschmann PU, Veltkamp R. Intracranial hemorrhage after ischemic stroke in patients on direct oral anticoagulants: results from a prospective observational study. Neurol Res Pract. 2026 Feb 26;8(1):13. doi: 10.1186/s42466-026-00462-y. |
| D009422 |
| Nervous System Diseases |
| D020300 | Intracranial Hemorrhages |
| D006470 | Hemorrhage |
| D010335 | Pathologic Processes |
| D013568 | Pathological Conditions, Signs and Symptoms |