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Trial record 1 of 2 for:    rasunoa prime
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Registry of Acute Stroke Under Novel Oral Anticoagulants - Prime (RASUNOA-Prime)

The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details.
 
ClinicalTrials.gov Identifier: NCT02533960
Recruitment Status : Completed
First Posted : August 27, 2015
Last Update Posted : November 2, 2022
Sponsor:
Collaborators:
Bayer Healthcare Pharmaceuticals, Inc./Bayer Schering Pharma
Boehringer Ingelheim
Bristol-Myers Squibb
Daiichi Sankyo, Inc.
University of Wuerzburg
Information provided by (Responsible Party):
Prof. Roland Veltkamp, University Hospital Heidelberg

Study Description
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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.

Condition or disease Intervention/treatment
Ischemic Stroke Intracerebral Hemorrhage Oral Anticoagulation Cardiovascular Diseases Vascular Diseases Other: not applicable (observational study)

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:

  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.

Study Design
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Study Type : Observational
Actual Enrollment : 3832 participants
Observational Model: Cohort
Time Perspective: Prospective
Official Title: Registry of Acute Stroke Under Novel Oral Anticoagulants - Prime
Actual Study Start Date : June 2015
Actual Primary Completion Date : January 2021
Actual Study Completion Date : June 2022

Resource links provided by the National Library of Medicine

MedlinePlus related topics: Blood Thinners

Groups and Cohorts
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Group/Cohort Intervention/treatment
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).

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

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

Ischemic stroke substudy: inclusion of 1000 patients without oral anticoagulation.

Hemorrhagic stroke substudy: inclusion of 333 patients without oral anticoagulation.

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


Outcome Measures
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Primary Outcome Measures :
  1. 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)

  2. 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)


Eligibility Criteria
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Information from the National Library of Medicine

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Ages Eligible for Study:   18 Years and older   (Adult, Older Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No
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.

Criteria

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
Contacts and Locations
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Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT02533960


Locations
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Germany
University Hospital Heidelberg
Heidelberg, Germany, 69120
Sponsors and Collaborators
University Hospital Heidelberg
Bayer Healthcare Pharmaceuticals, Inc./Bayer Schering Pharma
Boehringer Ingelheim
Bristol-Myers Squibb
Daiichi Sankyo, Inc.
University of Wuerzburg
Investigators
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Principal Investigator: Roland Veltkamp, Prof. Dr. med. Heidelberg University Hospital, Department of Neurology, Heidelberg, Germany; Department of Stroke Medicine, Imperial College London, London, United Kingdom.
More Information
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Publications:

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Responsible Party: Prof. Roland Veltkamp, Principal Investigator, University Hospital Heidelberg
ClinicalTrials.gov Identifier: NCT02533960    
Other Study ID Numbers: RASUNOA-Prime
First Posted: August 27, 2015    Key Record Dates
Last Update Posted: November 2, 2022
Last Verified: November 2022
Keywords provided by Prof. Roland Veltkamp, University Hospital Heidelberg:
Registry of Acute Stroke Under Novel Oral Anticoagulants
Additional relevant MeSH terms:
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Stroke
Ischemic Stroke
Cerebral Hemorrhage
Cardiovascular Diseases
Vascular Diseases
Hemorrhage
 Cerebrovascular Disorders
Brain Diseases
Central Nervous System Diseases
Nervous System Diseases
Pathologic Processes
Intracranial Hemorrhages