Registry of Acute Stroke Under Novel Oral Anticoagulants - Prime

Completed

• Conditions: Intracerebral Hemorrhage; Vascular Diseases; Oral Anticoagulation; Ischemic Stroke; Cardiovascular Diseases
• Interventions: Other: not applicable (observational study)

• Registration Number: NCT02533960
• Lead Sponsor: University Hospital Heidelberg

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.

Study Timeline

• Study Start: 2015-06
• Study First Submitted: 2015-08-23
• Study First Submitted QC: 2015-08-26
• Study First Posted: 2015-08-27
• Primary Completion: 2021-01
• Study Completion: 2022-06
• Status Verified: 2023-06
• Last Update Submitted: 2023-06-24
• Last Update Posted: 2023-06-27

Recruitment & Eligibility

• Status: COMPLETED
• Sex: All
• Target Recruitment: 3832

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

Study & Design

• Study Type: OBSERVATIONAL
• Study Design: Not specified

Arm && Interventions

Group	Intervention	Description
VKA	not applicable (observational study)	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)
NOAC	not applicable (observational study)	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).
Without OAC	not applicable (observational study)	Ischemic stroke substudy: inclusion of 1000 patients without oral anticoagulation. Hemorrhagic stroke substudy: inclusion of 333 patients without oral anticoagulation.

Primary Outcome Measures

Name	Time	Method
Primary hypothesis (hemorrhagic stroke substudy)	24 hours	Proportion of relevant secondary hematoma expansion on follow-up neuroimaging (hematoma expansion of \>= 33% or 6 mL)
Primary hypothesis (ischemic stroke substudy)	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)

Trial Locations

Locations (1)

University Hospital Heidelberg; 🇩🇪 Heidelberg, Germany