Registry of Acute Stroke Under Novel Oral Anticoagulants - Prime (RASUNOA-Prime)
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ClinicalTrials.gov Identifier: NCT02533960 |
Recruitment Status :
Completed
First Posted : August 27, 2015
Last Update Posted : November 2, 2022
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Tracking Information | ||||
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First Submitted Date | August 23, 2015 | |||
First Posted Date | August 27, 2015 | |||
Last Update Posted Date | November 2, 2022 | |||
Actual Study Start Date | June 2015 | |||
Actual Primary Completion Date | January 2021 (Final data collection date for primary outcome measure) | |||
Current Primary Outcome Measures |
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Original Primary Outcome Measures | Same as current | |||
Change History | ||||
Current Secondary Outcome Measures | Not Provided | |||
Original Secondary Outcome Measures | Not Provided | |||
Current Other Pre-specified Outcome Measures | Not Provided | |||
Original Other Pre-specified Outcome Measures | Not Provided | |||
Descriptive Information | ||||
Brief Title | Registry of Acute Stroke Under Novel Oral Anticoagulants - Prime | |||
Official Title | Registry of Acute Stroke Under Novel Oral Anticoagulants - Prime | |||
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. | |||
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:
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. |
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Study Type | Observational | |||
Study Design | Observational Model: Cohort Time Perspective: Prospective |
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Target Follow-Up Duration | Not Provided | |||
Biospecimen | Not Provided | |||
Sampling Method | Probability Sample | |||
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. |
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Condition |
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Intervention | Other: not applicable (observational study)
Observational study without study related intervention.
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Study Groups/Cohorts |
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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. | |||
* Includes publications given by the data provider as well as publications identified by ClinicalTrials.gov Identifier (NCT Number) in Medline. |
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Recruitment Information | ||||
Recruitment Status | Completed | |||
Actual Enrollment |
3832 | |||
Original Estimated Enrollment |
4000 | |||
Actual Study Completion Date | June 2022 | |||
Actual Primary Completion Date | January 2021 (Final data collection date for primary outcome measure) | |||
Eligibility Criteria | Ischemic stroke substudy: Inclusion Criteria:
Exclusion Criteria:
Hemorrhagic stroke substudy: Inclusion Criteria:
Exclusion Criteria:
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Sex/Gender |
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Ages | 18 Years and older (Adult, Older Adult) | |||
Accepts Healthy Volunteers | No | |||
Contacts | Contact information is only displayed when the study is recruiting subjects | |||
Listed Location Countries | Germany | |||
Removed Location Countries | ||||
Administrative Information | ||||
NCT Number | NCT02533960 | |||
Other Study ID Numbers | RASUNOA-Prime | |||
Has Data Monitoring Committee | No | |||
U.S. FDA-regulated Product | Not Provided | |||
IPD Sharing Statement | Not Provided | |||
Current Responsible Party | Prof. Roland Veltkamp, University Hospital Heidelberg | |||
Original Responsible Party | Same as current | |||
Current Study Sponsor | University Hospital Heidelberg | |||
Original Study Sponsor | Same as current | |||
Collaborators |
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Investigators |
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PRS Account | University Hospital Heidelberg | |||
Verification Date | November 2022 |