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

This study has been completed.
Sponsor:
ClinicalTrials.gov Identifier:
NCT01850797
First Posted: May 9, 2013
Last Update Posted: August 18, 2015
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.
Information provided by (Responsible Party):
Prof. Roland Veltkamp, University Hospital Heidelberg
  Purpose
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
Ischemic Stroke Intracranial Hemorrhage

Study Type: Observational
Study Design: Observational Model: Case-Only
Time Perspective: Prospective
Official Title: Registry of Acute Stroke Under New Oral Anticoagulants -Pilot (RASUNOA-Pilot)

Resource links provided by NLM:


Further study details as provided by Prof. Roland Veltkamp, University Hospital Heidelberg:

Primary Outcome Measures:
  • 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)

  • 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)


Enrollment: 353
Study Start Date: January 2012
Study Completion Date: August 2015
Primary Completion Date: March 2015 (Final data collection date for primary outcome measure)
Groups/Cohorts
NOAC
Patients receiving NOAC and suffering from ischemic stroke or intracranial bleeding.

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.
  Eligibility

Information from the National Library of Medicine

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Ages Eligible for Study:   18 Years and older   (Adult, Senior)
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.
Criteria

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
  Contacts and Locations
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): NCT01850797


Locations
Germany
University Hospital Heidelberg
Heidelberg, Germany, 69120
Sponsors and Collaborators
University Hospital Heidelberg
Investigators
Principal Investigator: Roland Veltkamp, Prof. University Hospital Heidelberg
  More Information

Additional Information:
Publications automatically indexed to this study by ClinicalTrials.gov Identifier (NCT Number):
Responsible Party: Prof. Roland Veltkamp, Senior Physician, Department of Neurology, University Hospital Heidelberg, University Hospital Heidelberg
ClinicalTrials.gov Identifier: NCT01850797     History of Changes
Other Study ID Numbers: S-556/2011
First Submitted: May 7, 2013
First Posted: May 9, 2013
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:
Stroke
Hemorrhage
Intracranial Hemorrhages
Cerebrovascular Disorders
Brain Diseases
Central Nervous System Diseases
Nervous System Diseases
Vascular Diseases
Cardiovascular Diseases
Pathologic Processes
Anticoagulants