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Clinical Trial Details — Status: Completed

Administrative data

NCT number NCT02533960
Other study ID # RASUNOA-Prime
Secondary ID
Status Completed
Phase
First received
Last updated
Start date June 2015
Est. completion date June 2022

Study information

Verified date June 2023
Source University Hospital Heidelberg
Contact n/a
Is FDA regulated No
Health authority
Study type Observational

Clinical 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. 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.


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: 1. 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. 2. 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. 3. 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.


Recruitment information / eligibility

Status Completed
Enrollment 3832
Est. completion date June 2022
Est. primary completion date January 2021
Accepts healthy volunteers No
Gender All
Age group 18 Years and older
Eligibility 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 - Anticoagulation with NOAC - Anticoagulation with VKA - No anticoagulation - Previous/present atrial fibrillation Exclusion Criteria: - No informed consent - Symptom-onset > 24 h Hemorrhagic stroke substudy: Inclusion Criteria: - Age >= 18 years - Acute primary intracerebral hemorrhage - - a) Anticoagulation with NOAC - - b) Anticoagulation with VKA - - c) No anticoagulation - Previous/present atrial fibrillation Exclusion Criteria: - No informed consent - Symptom-onset > 24 h

Study Design


Intervention

Other:
not applicable (observational study)
Observational study without study related intervention.

Locations

Country Name City State
Germany University Hospital Heidelberg Heidelberg

Sponsors (6)

Lead Sponsor Collaborator
University Hospital Heidelberg Bayer Healthcare Pharmaceuticals, Inc./Bayer Schering Pharma, Boehringer Ingelheim, Bristol-Myers Squibb, Daiichi Sankyo, Inc., University of Wuerzburg

Country where clinical trial is conducted

Germany, 

References & Publications (1)

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. — View Citation

Outcome

Type Measure Description Time frame Safety issue
Primary 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 Primary hypothesis (hemorrhagic stroke substudy) Proportion of relevant secondary hematoma expansion on follow-up neuroimaging (hematoma expansion of >= 33% or 6 mL) 24 hours
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