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Registry of Acute Stroke Under New Oral Anticoagulants -Pilot (RASUNOA-Pilot) (RASUNOA)

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. Identifier: NCT01850797
Recruitment Status : Completed
First Posted : May 9, 2013
Last Update Posted : August 18, 2015
Information provided by (Responsible Party):
Prof. Roland Veltkamp, University Hospital Heidelberg

Brief Summary:
The registry of acute stroke under new oral anticoagulants (RASUNOA) is a German multicenter, prospective, observational registry performed at about 50 study centers covering about 50.000 acute ischemic strokes and 6000 acute intracranial hemorrhages per year. Study enrollment will be consecutive. The RASUNOA registry study center is the University Medical Center of the Principal Investigator (Heidelberg, Germany). The registry will focus on treatment decisions and concepts in patients being under treatment with a new oral anticoagulant and suffering from acute ischemic or hemorrhagic stroke.

Condition or disease
Ischemic Stroke Intracranial Hemorrhage

Detailed Description:
The main purpose of the study is to collect information from a large, prospectively enrolling multicentre stroke database regarding the optimal management of ischemic and hemorrhagic stroke during anticoagulation with nOAC. Specifically, we aim to obtain critical information regarding the epidemiology, natural history, laboratory and neuroradiological aspects, clinical consequences, and the effects of treatment (i.e. thrombolysis/interventional recanalisation in ischemic stroke and hemostatic therapy in ICH, respectively) in stroke during nOAC. The Registry is not limited to a specific new OAC but intends to examine stroke during use of any of the approved nOAC. The study is not designed to perform comparisons among the different nOAC.

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Study Type : Observational
Actual Enrollment : 353 participants
Observational Model: Case-Only
Time Perspective: Prospective
Official Title: Registry of Acute Stroke Under New Oral Anticoagulants -Pilot (RASUNOA-Pilot)
Study Start Date : January 2012
Actual Primary Completion Date : March 2015
Actual Study Completion Date : August 2015

Resource links provided by the National Library of Medicine

Patients receiving NOAC and suffering from ischemic stroke or intracranial bleeding.

Primary Outcome Measures :
  1. Rate of hematoma expansion (ICH) [ Time Frame: 48h after ICH ]
    Rate of hematoma enlargement in patients with ICH between initial imaging and follow-up imaging (CT)

  2. Symptomatic intracerebral haemorrhage after thrombolysis [ Time Frame: 24 h ]
    In patients with ischemic stroke while under treatment with any of the new OAC who receive thrombolysis we will measure any hemorrhagic transformation on routine follow-up CT imaging (usually within 24h after thrombolysis)

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:   Non-Probability Sample
Study Population
patients suffering from acute ischemic stroke or intracranial hemorrhage while being anti coagulated. Only patients taking new oral anticoagulants will be included.

Inclusion Criteria:

  • age >= 18 years
  • informed consent
  • acute stroke or intracranial bleeding
  • therapy with a new oral anticoagulant (Dabigatran®, Rivaroxaban®, Apixaban®, Edoxaban®)

Exclusion Criteria:

  • missing informed consent

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 identifier (NCT number): NCT01850797

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University Hospital Heidelberg
Heidelberg, Germany, 69120
Sponsors and Collaborators
University Hospital Heidelberg
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Principal Investigator: Roland Veltkamp, Prof. University Hospital Heidelberg
Additional Information:
Publications automatically indexed to this study by Identifier (NCT Number):
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Responsible Party: Prof. Roland Veltkamp, Senior Physician, Department of Neurology, University Hospital Heidelberg, University Hospital Heidelberg Identifier: NCT01850797    
Other Study ID Numbers: S-556/2011
First Posted: May 9, 2013    Key Record Dates
Last Update Posted: August 18, 2015
Last Verified: August 2015
Keywords provided by Prof. Roland Veltkamp, University Hospital Heidelberg:
oral anticoagulants
ischemic stroke
blood thinner
intracranial hemorrhage
Additional relevant MeSH terms:
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Intracranial Hemorrhages
Cerebrovascular Disorders
Brain Diseases
Central Nervous System Diseases
Nervous System Diseases
Vascular Diseases
Cardiovascular Diseases
Pathologic Processes