Ischemic StrokeRASUNOA-PrimeNCT02533960
Registry of Acute Stroke Under Novel Oral Anticoagulants - Prime
An observational study of Ischemic Stroke and Intracerebral Hemorrhage, run by University Hospital Heidelberg at 1 site in Germany.
Trial summary
The Registry of Acute Stroke Under Novel Oral Anticoagulants-Prime (RASUNOA-Prime), an investigator-initiated study, is a German multicenter, prospective, observational registry. Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- Ischemic Stroke, Intracerebral Hemorrhage, Oral Anticoagulation
- What is being tested?
- not applicable (observational study)
- Type of treatment
- Pill or oral medicine
- How many people
- 3,832 participants
- Where
- 1 siteGermany
- Study dates
- Jun 2015to Jun 2022
- Phase
- Observational
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 years and older
- All sexes
- No healthy volunteers
- Adult, Older adult
Study population: 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.
Who may be able to join
- 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
Show all 13Show fewer
- Previous/present atrial fibrillation
- Age >= 18 years
- Acute primary intracerebral hemorrhage
- - a) Anticoagulation with NOAC
- - b) Anticoagulation with VKA
- - c) No anticoagulation
- Previous/present atrial fibrillation
Who cannot join
- No informed consent
- Symptom-onset > 24 h
- Hemorrhagic stroke substudy:
- No informed consent
- Symptom-onset > 24 h
Trial locations and contacts
1 site in 1 country.
About this study
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.
Read the 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:
- 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.
- Conditions
- Ischemic Stroke, Intracerebral Hemorrhage, Oral Anticoagulation, Cardiovascular Diseases, Vascular Diseases
- Being tested
- not applicable (observational study)
- Keywords
- Registry of Acute Stroke Under Novel Oral Anticoagulants
- Medical subject headings
- Ischemic Stroke, Cerebral Hemorrhage, Cardiovascular Diseases, Vascular Diseases
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
not applicable (observational study)Other
Observational study without study related intervention.
| Study group | Role | What they receive |
|---|---|---|
| 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). Receives: Other: not applicable (observational study) | |
| 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) Receives: Other: not applicable (observational study) | |
| Without OAC | Ischemic stroke substudy: inclusion of 1000 patients without oral anticoagulation.
Hemorrhagic stroke substudy: inclusion of 333 patients without oral anticoagulation. Receives: Other: not applicable (observational study) |
What is being measured
The primary outcome is the main question the study is designed to answer.
Primary hypothesis (ischemic stroke substudy)
Intracerebral hemorrhage complications (i.e. sICH, according to NINDS and SITS-MOST)
Measured: 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)
Measured: 24 hours
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted27 Aug 2015 (estimated)
- Study startJun 2015
- Primary completionJan 2021
- Study completionJun 2022
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (3)Papers the sponsor has linked to this study.
- Other trials for Ischemic StrokeStudies of the same condition, open and under way.
- More trials run by University Hospital HeidelbergThe sponsor's other registered studies.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Observational
- Observational model
- Cohort
- Time perspective
- Prospective
- Enrolment
- 3,832 participants (actual)
Sponsor and investigators
- Lead sponsor
- University Hospital Heidelberg
- Sponsor type
- University, hospital or other
- Collaborators
- Bayer Healthcare Pharmaceuticals, Inc./Bayer Schering Pharma, Boehringer Ingelheim, Bristol-Myers Squibb, Daiichi Sankyo, University of Wuerzburg
- Responsible party
- Principal investigator, Prof. Roland Veltkamp, University Hospital Heidelberg
- Investigators
- Roland Veltkamp, Prof. Dr. med., Principal investigator, Heidelberg University Hospital, Department of Neurology, Heidelberg, Germany; Department of Stroke Medicine, Imperial College London, London, United Kingdom.
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT02533960
- Sponsor's protocol ID
- RASUNOA-Prime
- Acronym
- RASUNOA-Prime
- Status last verified
- Jun 2023
- First submitted
- 23 Aug 2015
- Last updated
- 27 Jun 2023
- Results posted
- No
- Data monitoring committee
- No
Publications
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.
PubMed 31259266Veltkamp 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.
PubMed 42087546Purrucker 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.
PubMed 41749338
Study at a glance
From the registry record, last updated by the sponsor on 27 Jun 2023. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Registry of Acute Stroke Under Novel Oral Anticoagulants - Prime
- ClinicalTrials.gov ID
- NCT02533960
- Acronym / sponsor ID
- RASUNOA-Prime / RASUNOA-Prime
- Conditions
- Ischemic Stroke, Intracerebral Hemorrhage, Oral Anticoagulation, Cardiovascular Diseases, Vascular Diseases
- Keywords
- Registry of Acute Stroke Under Novel Oral Anticoagulants
- Study type
- Observational
- Recruitment status
- Completed
- Enrolment
- 3,832 participants (actual)
- Lead sponsor
- University Hospital HeidelbergUniversity, hospital or other
- Collaborators
- Bayer Healthcare Pharmaceuticals, Inc./Bayer Schering Pharma, Boehringer Ingelheim, Bristol-Myers Squibb, Daiichi Sankyo, University of Wuerzburg
- Study start
- Jun 2015 (actual)
- Primary completion
- Jan 2021 (actual)
- Study completion
- Jun 2022 (actual)
- First posted
- 27 Aug 2015 (estimated)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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:
- 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.
Study design
- Observational model
- Cohort
- Time perspective
- Prospective
- Number of arms
- 3
| Arm | Type | Receives |
|---|---|---|
| NOAC | – | Other: not applicable (observational study)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 | – | Other: not applicable (observational study)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 | – | Other: not applicable (observational study)Ischemic stroke substudy: inclusion of 1000 patients without oral anticoagulation. Hemorrhagic stroke substudy: inclusion of 333 patients without oral anticoagulation. |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
- Study population
- 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.
Key inclusion criteria (13 listed)
- Age >= 18 years
- Informed consent
- Acute ischemic stroke with either symptoms lasting ≥ 24h or evidence of infarction in brain imaging
- Previous/present atrial fibrillation
- Age >= 18 years
Key exclusion criteria (5 listed)
- No informed consent
- Symptom-onset > 24 h
- No informed consent
- Symptom-onset > 24 h
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| not applicable (observational study)Observational study without study related intervention. | Other | NOAC, VKA, Without OAC |
Primary outcome
Primary hypothesis (ischemic stroke substudy)
Time frame: 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)
Time frame: 24 hours
Proportion of relevant secondary hematoma expansion on follow-up neuroimaging (hematoma expansion of >= 33% or 6 mL)
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 27 Jun 2023.
- Background: PubMed 31259266Haas 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.
- Derived from this study: PubMed 42087546Veltkamp 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.
- Derived from this study: PubMed 41749338Purrucker 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.
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Roland Veltkamp, Prof. Dr. med. principal investigator
Heidelberg University Hospital, Department of Neurology, Heidelberg, Germany; Department of Stroke Medicine, Imperial College London, London, United Kingdom.
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
An observational study of Ischemic Stroke and Intracerebral Hemorrhage, run by University Hospital Heidelberg at 1 site in Germany.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 13 inclusion and 5 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: finished, as of the sponsor's last update on 27 Jun 2023. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in Germany. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Primary hypothesis (ischemic stroke substudy) (time frame: Participants will be followed for the duration of hospital stay, an expected average of less than 2 weeks"). The study lists 2 primary outcomes in all. It is what the study was designed to measure, not a finding.
Where can I read the original study information?
On the ClinicalTrials.gov record for NCT02533960, which also lists 3 linked publications.
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 27 Jun 2023.