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Trial record 2 of 2 for:    Rasunoa | stroke

Registry of Acute Stroke Under Novel Oral Anticoagulants - Prime (RASUNOA-Prime)

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ClinicalTrials.gov Identifier: NCT02533960
Recruitment Status : Recruiting
First Posted : August 27, 2015
Last Update Posted : February 6, 2019
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

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.


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Study Type : Observational
Estimated Enrollment : 4000 participants
Observational Model: Cohort
Time Perspective: Prospective
Official Title: Registry of Acute Stroke Under Novel Oral Anticoagulants - Prime
Study Start Date : June 2015
Estimated Primary Completion Date : December 2019
Estimated Study Completion Date : March 2020

Resource links provided by the National Library of Medicine

MedlinePlus related topics: Blood Thinners

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.




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)



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.
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

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


Contacts
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Contact: Roland Veltkamp, Prof. Dr. med. +49 6221 56 ext 38121 r.veltkamp@imperial.ac.uk
Contact: Timolaos Rizos, MD +49 6221 56 ext 6999 Timolaos.Rizos@med.uni-heidelberg.de

Locations
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Germany
University Hospital Heidelberg Recruiting
Heidelberg, Germany, 69120
Contact: Perdita Beck, SN    0049 6221 56 ext 38121    perdita.beck@med.uni-heidelberg.de   
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.

Additional Information:
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). European Stroke Journal. 2018 epub Dec 17 https://doi.org/10.1177/2396987318812644

Publications automatically indexed to this study by ClinicalTrials.gov Identifier (NCT Number):
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Responsible Party: Prof. Roland Veltkamp, Principal Investigator, University Hospital Heidelberg
ClinicalTrials.gov Identifier: NCT02533960     History of Changes
Other Study ID Numbers: RASUNOA-Prime
First Posted: August 27, 2015    Key Record Dates
Last Update Posted: February 6, 2019
Last Verified: February 2019

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
Cardiovascular Diseases
Hemorrhage
Vascular Diseases
Cerebral Hemorrhage
Cerebrovascular Disorders
Brain Diseases
Central Nervous System Diseases
Nervous System Diseases
Pathologic Processes
Intracranial Hemorrhages
Anticoagulants