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

University Hospital Heidelberg

Status: Completed

Conditions: Ischemic Stroke; Oral Anticoagulation; Cardiovascular Diseases; Intracerebral Hemorrhage; Vascular Diseases

Treatments: Other: not applicable (observational study)

Study type: Observational

Funder types: Other; Industry

Identifiers

NCT02533960

RASUNOA-Prime

Details and patient eligibility

About

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.

Full 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.

Enrollment: 3,832 patients

Sex: All

Ages: 18+ years old

Volunteers: No Healthy Volunteers

Inclusion and exclusion 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

Trial design

3,832 participants in 3 patient groups

NOAC

Description:

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).

Treatment:

Other: not applicable (observational study)

VKA

Description:

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)

Treatment:

Other: not applicable (observational study)

Without OAC

Description:

Ischemic stroke substudy: inclusion of 1000 patients without oral anticoagulation. Hemorrhagic stroke substudy: inclusion of 333 patients without oral anticoagulation.

Treatment:

Other: not applicable (observational study)