Registry of Acute Stroke Under Novel Oral Anticoagulants - Prime (RASUNOA-Prime)

June 24, 2023 updated by: Prof. Roland Veltkamp, University Hospital Heidelberg
The Registry of Acute Stroke Under Novel Oral Anticoagulants-Prime (RASUNOA-Prime), an investigator-initiated study, is a German multicenter, prospective, observational registry. It is performed at about 50 certified stroke-units and supported by an unrestricted grant from different pharmaceutical companies to the Heidelberg University Hospital. RASUNOA-Prime is designed to assess the emergency management of acute ischemic and hemorrhagic stroke patients with atrial fibrillation (AF) under different anticoagulation schemes pre stroke: Non-vitamin K antagonist oral anticoagulants (NOAC), Vitamin K antagonists (VKA), and no anticoagulation.

Study Overview

Status

Completed

Conditions

Intervention / Treatment

Detailed Description

The main purpose of this observational cohort study is to assess routine emergency management of acute stroke patients with AF under different anticoagulation schemes before the index stroke.

The investigators will address the following aims and objectives:

  1. Describing emergency management of stroke patients (IS and ICH) with AF in clinical routine including early diagnostic, therapeutic and preventive procedures and assessing variations in emergency management of patients with AF by anticoagulation schemes pre stroke.
  2. Identifying variations in risk of early complications (e.g. symptomatic secondary intracerebral haemorrhage in ischemic stroke patients) with AF by different anticoagulation schemes pre stroke.
  3. Determining factors influencing outcome of stroke patients with AF at three months and clarifying the potential influence of different anticoagulation schemes pre stroke.

The registry consists of 2 separate substudies that cover two different patient cohorts: ischemic stroke and intracerebral hemorrhage.

The study will collect information from prospectively enrolling Neurology departments with certified stroke units across Germany.

The principal investigator, Prof. Dr. med. Roland Veltkamp, is affiliated with Imperial College London, UK, and Heidelberg University Hospital, Germany.

Study Type

Observational

Enrollment (Actual)

3832

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Locations

  • Germany
      • Heidelberg, Germany, 69120
        • University Hospital Heidelberg

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

18 years and older (Adult, Older Adult)

Accepts Healthy Volunteers

No

Sampling Method

Probability Sample

Study Population

Acute stroke patients with atrial fibrillation (AF) under different anticoagulation schemes pre stroke [Non-vitamin K antagonists oral anticoagulants (NOAC, also referred to as novel or new oral anticoagulants), Vitamin K antagonists (VKA), and no oral anticoagulation. According to the type of stroke, patients will be enrolled in the ischemic or hemorrhagic stroke substudy.

NOTE: As of July 2019, enrollment in the ischemic stroke substudy was terminated due to achievement of the targeted enrolling numbers.

NOTE: As of April 2021, enrollment in the intracerebral hemorrhage substudy was terminated due to achievement of the targeted enrolling numbers.

Description

Ischemic stroke substudy:

Inclusion Criteria:

  • Age >= 18 years
  • Informed consent

  • Acute ischemic stroke with either symptoms lasting ≥ 24h or evidence of infarction in brain imaging

    • Anticoagulation with NOAC
    • Anticoagulation with VKA
    • No anticoagulation
  • Previous/present atrial fibrillation

Exclusion Criteria:

  • No informed consent
  • Symptom-onset > 24 h

Hemorrhagic stroke substudy:

Inclusion Criteria:

  • Age >= 18 years
  • Acute primary intracerebral hemorrhage
  • - a) Anticoagulation with NOAC
  • - b) Anticoagulation with VKA
  • - c) No anticoagulation
  • Previous/present atrial fibrillation

Exclusion Criteria:

  • No informed consent
  • Symptom-onset > 24 h

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

Cohorts and Interventions

Group / Cohort
Intervention / Treatment
NOAC

Ischemic stroke substudy: inclusion of 1000 patients under treatment with non-vitamin K antagonist oral anticoagulants (NOACs).

Hemorrhagic stroke substudy: inclusion of 334 patients under treatment with non-vitamin K antagonist oral anticoagulants (NOACs).
Other: not applicable (observational study)
Observational study without study related intervention.
VKA

Ischemic stroke substudy: inclusion of 1000 patients under treatment with vitamin K antagonists (VKA).

Hemorrhagic stroke substudy: inclusion of 333 patients under treatment with vitamin K antagonists (VKA)
Other: not applicable (observational study)
Observational study without study related intervention.
Without OAC

Ischemic stroke substudy: inclusion of 1000 patients without oral anticoagulation.

Hemorrhagic stroke substudy: inclusion of 333 patients without oral anticoagulation.
Other: not applicable (observational study)
Observational study without study related intervention.

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Measure Description
Time Frame
Primary hypothesis (ischemic stroke substudy)
Time Frame: Participants will be followed for the duration of hospital stay, an expected average of less than 2 weeks"
Intracerebral hemorrhage complications (i.e. sICH, according to NINDS and SITS-MOST)
Participants will be followed for the duration of hospital stay, an expected average of less than 2 weeks"
Primary hypothesis (hemorrhagic stroke substudy)
Time Frame: 24 hours
Proportion of relevant secondary hematoma expansion on follow-up neuroimaging (hematoma expansion of >= 33% or 6 mL)
24 hours

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

University Hospital Heidelberg

Collaborators

Bristol-Myers Squibb
Boehringer Ingelheim
Daiichi Sankyo, Inc.
University of Wuerzburg
Bayer Healthcare Pharmaceuticals, Inc./Bayer Schering Pharma

Investigators

  • Principal Investigator: Roland Veltkamp, Prof. Dr. med., Heidelberg University Hospital, Department of Neurology, Heidelberg, Germany; Department of Stroke Medicine, Imperial College London, London, United Kingdom.

Publications and helpful links

The person responsible for entering information about the study voluntarily provides these publications. These may be about anything related to the study.

General Publications

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start (Actual)

June 1, 2015

Primary Completion (Actual)

January 1, 2021

Study Completion (Actual)

June 1, 2022

Study Registration Dates

First Submitted

August 23, 2015

First Submitted That Met QC Criteria

August 26, 2015

First Posted (Estimated)

August 27, 2015

Study Record Updates

Last Update Posted (Actual)

June 27, 2023

Last Update Submitted That Met QC Criteria

June 24, 2023

Last Verified

June 1, 2023

More Information

Terms related to this study

Keywords

Additional Relevant MeSH Terms

Other Study ID Numbers

  • RASUNOA-Prime

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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