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.

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Key information

Conditions

Ischemic Stroke Brain Diseases Cardiovascular Diseases Central Nervous System Diseases Cerebrovascular Disorders Hemorrhage Intracranial Hemorrhage Intracranial Hemorrhages Nervous System Diseases Pathologic Processes Pathological Conditions, Signs and Symptoms Stroke Vascular Diseases

Age range

18 year and older

Sex eligibility

All sexes

Study type

Observational

Primary location

University Hospital Heidelberg

Heidelberg, 69120, Germany

About this study

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.

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

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

Treatment and study plan

Primary outcomes

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)

Sponsors and collaborators

Lead sponsor

University Hospital Heidelberg

Other

Registry information

Acronym: RASUNOA

Important dates

Study start: 2012
Primary completion: 2015
Study completion: 2015
First posted: May 9, 2013
Registry last updated: Aug 18, 2015

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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