NCT01850797

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.

Trial Health

87
On Track

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Enrollment
353

participants targeted

Target at P75+ for all trials

Timeline
Completed

Started Jan 2012

Typical duration for all trials

Geographic Reach
1 country

1 active site

Status
completed

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

Study Start

First participant enrolled

January 1, 2012

Completed
1.3 years until next milestone

First Submitted

Initial submission to the registry

May 7, 2013

Completed
2 days until next milestone

First Posted

Study publicly available on registry

May 9, 2013

Completed
1.8 years until next milestone

Primary Completion

Last participant's last visit for primary outcome

March 1, 2015

Completed
5 months until next milestone

Study Completion

Last participant's last visit for all outcomes

August 1, 2015

Completed
Last Updated

August 18, 2015

Status Verified

August 1, 2015

Enrollment Period

3.2 years

First QC Date

May 7, 2013

Last Update Submit

August 15, 2015

Conditions

Ischemic StrokeIntracranial Hemorrhage

Keywords

oral anticoagulantsischemic strokeblood thinnerintracranial hemorrhage

Outcome Measures

Primary Outcomes (2)

  • 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

Study Arms (1)

NOAC

Patients receiving NOAC and suffering from ischemic stroke or intracranial bleeding.

Eligibility Criteria

Age18 Years+
Sexall
Healthy VolunteersNo
Age GroupsAdult (18-64), Older Adult (65+)
Sampling MethodNon-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.

You may qualify if:

  • age \>= 18 years
  • informed consent
  • acute stroke or intracranial bleeding
  • therapy with a new oral anticoagulant (Dabigatran®, Rivaroxaban®, Apixaban®, Edoxaban®)

You may not qualify if:

  • missing informed consent

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

University Hospital Heidelberg

Heidelberg, 69120, Germany

Location

Related Publications (2)

  • 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.

    PMID: 27899756DERIVED

  • 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.

    PMID: 26931156DERIVED

Related Links

MeSH Terms

Conditions

Ischemic StrokeIntracranial Hemorrhages

Condition Hierarchy (Ancestors)

StrokeCerebrovascular DisordersBrain DiseasesCentral Nervous System DiseasesNervous System DiseasesVascular DiseasesCardiovascular DiseasesHemorrhagePathologic ProcessesPathological Conditions, Signs and Symptoms

Study Officials

  • Roland Veltkamp, Prof.

    University Hospital Heidelberg

    PRINCIPAL INVESTIGATOR

Study Design

Study Type
observational
Observational Model
CASE ONLY
Time Perspective
PROSPECTIVE
Sponsor Type
OTHER
Responsible Party
PRINCIPAL INVESTIGATOR
PI Title
Senior Physician, Department of Neurology, University Hospital Heidelberg

Study Record Dates

First Submitted

May 7, 2013

First Posted

May 9, 2013

Study Start

January 1, 2012

Primary Completion

March 1, 2015

Study Completion

August 1, 2015

Last Updated

August 18, 2015

Record last verified: 2015-08

Locations

DE(1)