Clinical trial NCT01850797: Registry of Acute Stroke Under New Oral Anticoagulants -Pilot (RASUNOA-Pilot)
Official title: Registry of Acute Stroke Under New Oral Anticoagulants -Pilot (RASUNOA-Pilot)
Study type: OBSERVATIONAL
Overall status: COMPLETED
Conditions: Ischemic Stroke
Intracranial Hemorrhage
Keywords: oral anticoagulants
ischemic stroke
blood thinner
intracranial hemorrhage
Lead sponsor: University Hospital Heidelberg
Sponsor class: OTHER
First posted: 2013-05-09
Enrollment: 353
Sex: ALL
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Observational model: CASE_ONLY
Time perspective: PROSPECTIVE
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.

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.

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

Primary outcomes:
measure: Rate of hematoma expansion (ICH)
timeFrame: 48h after ICH
measure: Symptomatic intracerebral haemorrhage after thrombolysis
timeFrame: 24 h
Secondary outcomes:
Other outcomes:
Locations:
city: Heidelberg
country: Germany
facility: University Hospital Heidelberg
Study officials:
affiliation: University Hospital Heidelberg
name: Roland Veltkamp, Prof.
role: PRINCIPAL_INVESTIGATOR
References:
citation: Purrucker JC, Haas K, Rizos T, Khan S, Poli S, Kraft P, Kleinschnitz C, Dziewas R, Binder A, Palm F, Jander S, Soda H, Heuschmann PU, Veltkamp R; RASUNOA Investigators (Registry of Acute Stroke Under New Oral Anticoagulants). Coagulation Testing in Acute Ischemic Stroke Patients Taking Non-Vitamin K Antagonist Oral Anticoagulants. Stroke. 2017 Jan;48(1):152-158. doi: 10.1161/STROKEAHA.116.014963. Epub 2016 Nov 29.
citation: Purrucker JC, Wolf M, Haas K, Rizos T, Khan S, Dziewas R, Kleinschnitz C, Binder A, Groschel K, Hennerici MG, Lobotesis K, Poli S, Seidel G, Neumann-Haefelin T, Ringleb PA, Heuschmann PU, Veltkamp R. Safety of Endovascular Thrombectomy in Patients Receiving Non-Vitamin K Antagonist Oral Anticoagulants. Stroke. 2016 Apr;47(4):1127-30. doi: 10.1161/STROKEAHA.116.012684. Epub 2016 Mar 1.