Ischemic StrokeRASUNOANCT01850797
Registry of Acute Stroke Under New Oral Anticoagulants -Pilot (RASUNOA-Pilot)
An observational study of Ischemic Stroke and Intracranial Hemorrhage, run by University Hospital Heidelberg at 1 site in Germany.
Trial summary
The registry of acute stroke under new oral anticoagulants (RASUNOA) is a German multicenter, prospective, observational registry performed at about 50 study centers covering about 50.000 acute ischemic strokes and 6000 acute intracranial hemorrhages per year. Study enrollment will be consecutive. Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- Ischemic Stroke, Intracranial Hemorrhage
- How many people
- 353 participants
- Where
- 1 siteGermany
- Study dates
- Jan 2012to Aug 2015
- 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: patients suffering from acute ischemic stroke or intracranial hemorrhage while being anti coagulated. Only patients taking new oral anticoagulants will be included.
Who may be able to join
- age >= 18 years
- informed consent
- acute stroke or intracranial bleeding
- therapy with a new oral anticoagulant (Dabigatran®, Rivaroxaban®, Apixaban®, Edoxaban®)
Who cannot join
- missing informed consent
Trial locations and contacts
1 site in 1 country.
About this study
The registry of acute stroke under new oral anticoagulants (RASUNOA) is a German multicenter, prospective, observational registry performed at about 50 study centers covering about 50.000 acute ischemic strokes and 6000 acute intracranial hemorrhages per year. Study enrollment will be consecutive. The RASUNOA registry study center is the University Medical Center of the Principal Investigator (Heidelberg, Germany). The registry will focus on treatment decisions and concepts in patients being under treatment with a new oral anticoagulant and suffering from acute ischemic or hemorrhagic stroke.
Read the detailed description
The main purpose of the study is to collect information from a large, prospectively enrolling multicentre stroke database regarding the optimal management of ischemic and hemorrhagic stroke during anticoagulation with nOAC. Specifically, we aim to obtain critical information regarding the epidemiology, natural history, laboratory and neuroradiological aspects, clinical consequences, and the effects of treatment (i.e. thrombolysis/interventional recanalisation in ischemic stroke and hemostatic therapy in ICH, respectively) in stroke during nOAC. The Registry is not limited to a specific new OAC but intends to examine stroke during use of any of the approved nOAC. The study is not designed to perform comparisons among the different nOAC.
- Conditions
- Ischemic Stroke, Intracranial Hemorrhage
- Keywords
- oral anticoagulants, ischemic stroke, blood thinner, intracranial hemorrhage
- Medical subject headings
- Ischemic Stroke, Intracranial Hemorrhages
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
| Study group | Role | What they receive |
|---|---|---|
| NOAC | Patients receiving NOAC and suffering from ischemic stroke or intracranial bleeding. |
What is being measured
The primary outcome is the main question the study is designed to answer.
Rate of hematoma expansion (ICH)
Rate of hematoma enlargement in patients with ICH between initial imaging and follow-up imaging (CT)
Measured: 48h after ICH
Symptomatic intracerebral haemorrhage after thrombolysis
In patients with ischemic stroke while under treatment with any of the new OAC who receive thrombolysis we will measure any hemorrhagic transformation on routine follow-up CT imaging (usually within 24h after thrombolysis)
Measured: 24 h
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted9 May 2013 (estimated)
- Study startJan 2012
- Primary completionMar 2015
- Study completionAug 2015
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (2)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
- Case only
- Time perspective
- Prospective
- Enrolment
- 353 participants (actual)
Sponsor and investigators
- Lead sponsor
- University Hospital Heidelberg
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Prof. Roland Veltkamp, University Hospital Heidelberg
- Investigators
- Roland Veltkamp, Prof., Principal investigator, University Hospital Heidelberg
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT01850797
- Sponsor's protocol ID
- S-556/2011
- Acronym
- RASUNOA
- Status last verified
- Aug 2015
- First submitted
- 7 May 2013
- Last updated
- 18 Aug 2015
- Results posted
- No
- Data monitoring committee
- No
Publications
Purrucker JC, Haas K, Rizos T, Khan S, Poli S, Kraft P, Kleinschnitz C, Dziewas R, Binder A, Palm F, Jander S, Soda H, Heuschmann PU, Veltkamp R; RASUNOA Investigators (Registry of Acute Stroke Under New Oral Anticoagulants). Coagulation Testing in Acute Ischemic Stroke Patients Taking Non-Vitamin K Antagonist Oral Anticoagulants. Stroke. 2017 Jan;48(1):152-158. doi: 10.1161/STROKEAHA.116.014963. Epub 2016 Nov 29.
PubMed 27899756Purrucker JC, Wolf M, Haas K, Rizos T, Khan S, Dziewas R, Kleinschnitz C, Binder A, Groschel K, Hennerici MG, Lobotesis K, Poli S, Seidel G, Neumann-Haefelin T, Ringleb PA, Heuschmann PU, Veltkamp R. Safety of Endovascular Thrombectomy in Patients Receiving Non-Vitamin K Antagonist Oral Anticoagulants. Stroke. 2016 Apr;47(4):1127-30. doi: 10.1161/STROKEAHA.116.012684. Epub 2016 Mar 1.
PubMed 26931156
Study at a glance
From the registry record, last updated by the sponsor on 18 Aug 2015. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Registry of Acute Stroke Under New Oral Anticoagulants -Pilot (RASUNOA-Pilot)
- ClinicalTrials.gov ID
- NCT01850797
- Acronym / sponsor ID
- RASUNOA / S-556/2011
- Conditions
- Ischemic Stroke, Intracranial Hemorrhage
- Keywords
- oral anticoagulants, ischemic stroke, blood thinner, intracranial hemorrhage
- Study type
- Observational
- Recruitment status
- Completed
- Enrolment
- 353 participants (actual)
- Lead sponsor
- University Hospital HeidelbergUniversity, hospital or other
- Study start
- Jan 2012
- Primary completion
- Mar 2015 (actual)
- Study completion
- Aug 2015 (actual)
- First posted
- 9 May 2013 (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 new oral anticoagulants (RASUNOA) is a German multicenter, prospective, observational registry performed at about 50 study centers covering about 50.000 acute ischemic strokes and 6000 acute intracranial hemorrhages per year. Study enrollment will be consecutive. The RASUNOA registry study center is the University Medical Center of the Principal Investigator (Heidelberg, Germany). The registry will focus on treatment decisions and concepts in patients being under treatment with a new oral anticoagulant and suffering from acute ischemic or hemorrhagic stroke.
Detailed description
The main purpose of the study is to collect information from a large, prospectively enrolling multicentre stroke database regarding the optimal management of ischemic and hemorrhagic stroke during anticoagulation with nOAC. Specifically, we aim to obtain critical information regarding the epidemiology, natural history, laboratory and neuroradiological aspects, clinical consequences, and the effects of treatment (i.e. thrombolysis/interventional recanalisation in ischemic stroke and hemostatic therapy in ICH, respectively) in stroke during nOAC. The Registry is not limited to a specific new OAC but intends to examine stroke during use of any of the approved nOAC. The study is not designed to perform comparisons among the different nOAC.
Study design
- Observational model
- Case only
- Time perspective
- Prospective
- Number of arms
- 1
| Arm | Type | Receives |
|---|---|---|
| NOAC | – | –Patients receiving NOAC and suffering from ischemic stroke or intracranial bleeding. |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
- Study population
- patients suffering from acute ischemic stroke or intracranial hemorrhage while being anti coagulated. Only patients taking new oral anticoagulants will be included.
Key inclusion criteria (4 listed)
- age >= 18 years
- informed consent
- acute stroke or intracranial bleeding
- therapy with a new oral anticoagulant (Dabigatran®, Rivaroxaban®, Apixaban®, Edoxaban®)
Key exclusion criteria (1 listed)
- missing informed consent
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Primary outcome
Rate of hematoma expansion (ICH)
Time frame: 48h after ICH
Rate of hematoma enlargement in patients with ICH between initial imaging and follow-up imaging (CT)
Symptomatic intracerebral haemorrhage after thrombolysis
Time frame: 24 h
In patients with ischemic stroke while under treatment with any of the new OAC who receive thrombolysis we will measure any hemorrhagic transformation on routine follow-up CT imaging (usually within 24h after thrombolysis)
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 18 Aug 2015.
- Derived from this study: PubMed 27899756Purrucker JC, Haas K, Rizos T, Khan S, Poli S, Kraft P, Kleinschnitz C, Dziewas R, Binder A, Palm F, Jander S, Soda H, Heuschmann PU, Veltkamp R; RASUNOA Investigators (Registry of Acute Stroke Under New Oral Anticoagulants). Coagulation Testing in Acute Ischemic Stroke Patients Taking Non-Vitamin K Antagonist Oral Anticoagulants. Stroke. 2017 Jan;48(1):152-158. doi: 10.1161/STROKEAHA.116.014963. Epub 2016 Nov 29.
- Derived from this study: PubMed 26931156Purrucker JC, Wolf M, Haas K, Rizos T, Khan S, Dziewas R, Kleinschnitz C, Binder A, Groschel K, Hennerici MG, Lobotesis K, Poli S, Seidel G, Neumann-Haefelin T, Ringleb PA, Heuschmann PU, Veltkamp R. Safety of Endovascular Thrombectomy in Patients Receiving Non-Vitamin K Antagonist Oral Anticoagulants. Stroke. 2016 Apr;47(4):1127-30. doi: 10.1161/STROKEAHA.116.012684. Epub 2016 Mar 1.
- RASUNOA - Center HomepageLink provided by the sponsor.
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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. principal investigator
University Hospital Heidelberg
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 Intracranial 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 4 inclusion and 1 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 18 Aug 2015. 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?
Rate of hematoma expansion (ICH) (time frame: 48h after ICH). 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 NCT01850797, which also lists 2 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 18 Aug 2015.