Registry of Acute Stroke Under New Oral Anticoagulants -Pilot (RASUNOA-Pilot)
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.
|Study Design:||Observational Model: Case-Only
Time Perspective: Prospective
|Official Title:||Registry of Acute Stroke Under New Oral Anticoagulants -Pilot (RASUNOA-Pilot)|
- 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)
|Study Start Date:||January 2012|
|Estimated Study Completion Date:||December 2015|
|Estimated Primary Completion Date:||March 2015 (Final data collection date for primary outcome measure)|
Patients receiving NOAC and suffering from ischemic stroke or intracranial bleeding.
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.
Please refer to this study by its ClinicalTrials.gov identifier: NCT01850797
|University Hospital Heidelberg|
|Heidelberg, Germany, 69120|
|Principal Investigator:||Roland Veltkamp, Prof.||University Hospital Heidelberg|