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NCT Number: NCT02533960

Registry of Acute Stroke Under Novel Oral Anticoagulants - Prime

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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Key information

Conditions

Ischemic Stroke Brain Diseases Cardiovascular Diseases Central Nervous System Diseases Cerebral Hemorrhage Cerebrovascular Disorders Hemorrhage Intracerebral Hemorrhage Intracranial Hemorrhages Nervous System Diseases Oral Anticoagulation Pathologic Processes Pathological Conditions, Signs and Symptoms Stroke Vascular Diseases

Age range

18 year and older

Sex eligibility

All sexes

Study type

Observational

Primary location

University Hospital Heidelberg

Heidelberg, 69120, Germany

About this study

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:

  • 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.
  • 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.
  • 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.

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

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

Treatment and study plan

Not applicable (Observational Study)

Other

Observational study without study related intervention.

Primary outcomes

  1. 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)

  2. 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)

Sponsors and collaborators

Lead sponsor

University Hospital Heidelberg

Other

Collaborators

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

Registry information

Acronym: RASUNOA-Prime

Important dates

Study start
2015
Primary completion
2021
Study completion
2022
First posted
Aug 27, 2015
Registry last updated
Jun 27, 2023

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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