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

This study is currently recruiting participants. (see Contacts and Locations)
Verified May 2013 by University Hospital Heidelberg
Sponsor:
Information provided by (Responsible Party):
Prof. Roland Veltkamp, University Hospital Heidelberg
ClinicalTrials.gov Identifier:
NCT01850797
First received: May 7, 2013
Last updated: NA
Last verified: May 2013
History: No changes posted
  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

Resource links provided by NLM:


Further study details as provided by University Hospital Heidelberg:

Primary Outcome Measures:
  • Rate of hematoma expansion (ICH) [ Time Frame: 48h after ICH ] [ Designated as safety issue: No ]
    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 ] [ Designated as safety issue: Yes ]
    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)


Estimated Enrollment: 2000
Study Start Date: January 2012
Estimated Study Completion Date: December 2015
Estimated Primary Completion Date: December 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

Ages Eligible for Study:   18 Years and older
Genders Eligible for Study:   Both
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
Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the Contacts provided below. For general information, see Learn About Clinical Studies.

Please refer to this study by its ClinicalTrials.gov identifier: NCT01850797

Contacts
Contact: Roland Veltkamp, Prof. 0049 6221 56 ext 7504 roland.veltkamp@med.uni-heidelberg.de
Contact: Jan C Purrucker, MD 0049 6221 56 ext 37718 jan.purrucker@med.uni-heidelberg.de

Locations
Germany
University Hospital Heidelberg Recruiting
Heidelberg, Germany, 69120
Contact: Perdita Beck, SN    0049 6221 56 ext 38121    perdita.beck@med.uni-heidelberg.de   
Sub-Investigator: Jan C Purrucker, MD         
Sub-Investigator: Timolaos Rizos, MD         
Sponsors and Collaborators
University Hospital Heidelberg
Investigators
Principal Investigator: Roland Veltkamp, Prof. University Hospital Heidelberg
  More Information

Additional Information:
No publications provided

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
Study First Received: May 7, 2013
Last Updated: May 7, 2013
Health Authority: Germany: ethics committee

Keywords provided by University Hospital Heidelberg:
oral anticoagulants
ischemic stroke
blood thinner
intracranial hemorrhage

Additional relevant MeSH terms:
Anticoagulants
Hemorrhage
Ischemia
Stroke
Cerebral Infarction
Intracranial Hemorrhages
Pathologic Processes
Cerebrovascular Disorders
Brain Diseases
Central Nervous System Diseases
Nervous System Diseases
Vascular Diseases
Cardiovascular Diseases
Brain Infarction
Brain Ischemia
Hematologic Agents
Therapeutic Uses
Pharmacologic Actions

ClinicalTrials.gov processed this record on August 28, 2014