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

Ischemic Stroke Clinical Trial

— RASUNOA  

Official title:

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

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT01850797
• Other study ID #: S-556/2011
• Status: Completed
• Phase: N/A
• First received: May 7, 2013
• Last updated: August 15, 2015
• Start date: January 2012
• Est. completion date: August 2015

Study information

• Verified date: August 2015
• Source: University Hospital Heidelberg
• Contact: n/a
• Is FDA regulated: No
• Health authority: Germany: ethics committee
• Study type: Observational

Clinical Trial 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.

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.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 353
• Est. completion date: August 2015
• Est. primary completion date: March 2015
• Accepts healthy volunteers: No
• Gender: Both
• Age group: 18 Years and older

Eligibility

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

Study Design

Observational Model: Case-Only, Time Perspective: Prospective

Related Conditions & MeSH terms

• Hemorrhage
• Intracranial Hemorrhage
• Intracranial Hemorrhages
• Ischemic Stroke
• Stroke

Locations

Country	Name	City	State
Germany	University Hospital Heidelberg	Heidelberg

Sponsors (1)

Lead Sponsor	Collaborator
University Hospital Heidelberg

Country where clinical trial is conducted

Germany, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Rate of hematoma expansion (ICH)	Rate of hematoma enlargement in patients with ICH between initial imaging and follow-up imaging (CT)	48h after ICH	No
Primary	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	Yes

External Links

•   RASUNOA - Center Homepage