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

Study Overview
=================
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.

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.

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

Conditions
-----------------
Ischemic Stroke, Intracranial Hemorrhage

Participation Criteria
=================
Eligibility 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

Ages Eligible for Study
-----------------
Minimum Age: 18 Years

Sexes Eligible for Study
-----------------
All

Accepts Healthy Volunteers
-----------------
No

Study Plan
=================
How is the study designed?
-----------------

Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| NOAC<br>Patients receiving NOAC and suffering from ischemic stroke or intracranial bleeding. | |

What is the study measuring?
-----------------
Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Rate of hematoma expansion (ICH) | Rate of hematoma enlargement in patients with ICH between initial imaging and follow-up imaging (CT) | 48h after ICH | 
| Symptomatic intracerebral haemorrhage after thrombolysis | 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) | 24 h | 

 Terms related to the study
=================
Keywords Provided by Centre Hospitalier Valida
-----------------
oral anticoagulants, ischemic stroke, blood thinner, intracranial hemorrhage