Registry of Acute Stroke Under Novel Oral Anticoagulants - Prime

University Hospital Heidelberg3,832 enrolled

Overview

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.

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

3,832

Conditions

Ischemic Stroke

Eligibility

Sex: ALLMin age: 18 Years

Medical Language ↔ Plain English

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

Outcomes

Primary Outcomes

Primary hypothesis (ischemic stroke substudy)

Intracerebral hemorrhage complications (i.e. sICH, according to NINDS and SITS-MOST)

Time frame: Participants will be followed for the duration of hospital stay, an expected average of less than 2 weeks"

Primary hypothesis (hemorrhagic stroke substudy)

Proportion of relevant secondary hematoma expansion on follow-up neuroimaging (hematoma expansion of \>= 33% or 6 mL)

Time frame: 24 hours