Registry of Acute Stroke Under Novel Oral Anticoagulants - Prime

Cardiovascular Diseases Clinical Trial

— RASUNOA-Prime  

Official title:

Registry of Acute Stroke Under Novel Oral Anticoagulants - Prime

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT02533960
• Other study ID #: RASUNOA-Prime
• Status: Completed
• 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
• 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

Related Conditions & MeSH terms

• Cardiovascular Diseases
• Cerebral Hemorrhage
• Hemorrhage
• Intracerebral Hemorrhage
• Ischemic Stroke
• Oral Anticoagulation
• Stroke
• Vascular Diseases

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