Registry of Acute Stroke Under Novel Oral Anticoagulants

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

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Recruitment Status

COMPLETED

Total Enrollment

3832 participants

Study Classification

OBSERVATIONAL

Study Start Date

2015-06-30

Study Completion Date

2022-06-30

Brief Summary

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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.

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Detailed Description

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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.

Conditions

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Ischemic Stroke Intracerebral Hemorrhage Oral Anticoagulation Cardiovascular Diseases Vascular Diseases

Study Design

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Observational Model Type

COHORT

Study Time Perspective

PROSPECTIVE

Study Groups

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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).

not applicable (observational study)

Intervention Type OTHER

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)

not applicable (observational study)

Intervention Type OTHER

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.

not applicable (observational study)

Intervention Type OTHER

Observational study without study related intervention.

Interventions

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not applicable (observational study)

Observational study without study related intervention.

Intervention Type OTHER

Eligibility Criteria

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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

* 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

Hemorrhagic stroke substudy:

* No informed consent
* Symptom-onset \> 24 h

Minimum Eligible Age

18 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

No

Responsible Party

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Prof. Roland Veltkamp

Principal Investigator

Responsibility Role PRINCIPAL_INVESTIGATOR

Principal Investigators

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Roland Veltkamp, Prof. Dr. med.

Role: PRINCIPAL_INVESTIGATOR

Heidelberg University Hospital, Department of Neurology, Heidelberg, Germany; Department of Stroke Medicine, Imperial College London, London, United Kingdom.