Clinical trial NCT02533960: Registry of Acute Stroke Under Novel Oral Anticoagulants - Prime
Official title: Registry of Acute Stroke Under Novel Oral Anticoagulants - Prime
Study type: OBSERVATIONAL
Overall status: COMPLETED
Conditions: Ischemic Stroke
Intracerebral Hemorrhage
Oral Anticoagulation
Cardiovascular Diseases
Vascular Diseases
Keywords: Registry of Acute Stroke Under Novel Oral Anticoagulants
Lead sponsor: University Hospital Heidelberg
Sponsor class: OTHER
Collaborators: name: Bayer Healthcare Pharmaceuticals, Inc./Bayer Schering Pharma
name: Boehringer Ingelheim
name: Bristol-Myers Squibb
name: Daiichi Sankyo
name: University of Wuerzburg
First posted: 2015-08-27
Enrollment: 3832
Sex: ALL
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Observational model: COHORT
Time perspective: PROSPECTIVE
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.

Brief summary: 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.

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.

Eligibility criteria: 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

Primary outcomes:
measure: Primary hypothesis (ischemic stroke substudy)
timeFrame: Participants will be followed for the duration of hospital stay, an expected average of less than 2 weeks"
measure: Primary hypothesis (hemorrhagic stroke substudy)
timeFrame: 24 hours
Secondary outcomes:
Other outcomes:
Locations:
city: Heidelberg
country: Germany
facility: University Hospital Heidelberg
Study officials:
affiliation: Heidelberg University Hospital, Department of Neurology, Heidelberg, Germany; Department of Stroke Medicine, Imperial College London, London, United Kingdom.
name: Roland Veltkamp, Prof. Dr. med.
role: PRINCIPAL_INVESTIGATOR
References:
citation: Haas K, Purrucker JC, Rizos T, Heuschmann PU, Veltkamp R. Rationale and design of the Registry of Acute Stroke Under Novel Oral Anticoagulants-prime (RASUNOA-prime). Eur Stroke J. 2019 Jun;4(2):181-188. doi: 10.1177/2396987318812644. Epub 2018 Dec 17.