Registry of Acute Stroke Under Novel Oral Anticoagulants

Status Completed

Clinical Trial 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.

Clinical Trial 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 Design

Related Conditions & MeSH terms

Clinical Trial Details

NCT number	NCT02533960
Study type	Observational
Source	University Hospital Heidelberg
Contact
Status	Completed
Phase
Start date	June 2015
Completion date	June 2022

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Clinical trials are conducted in a series of steps, called phases - each phase is designed to answer a separate research question.

Phase 1: Researchers test a new drug or treatment in a small group of people for the first time to evaluate its safety, determine a safe dosage range, and identify side effects.
Phase 2: The drug or treatment is given to a larger group of people to see if it is effective and to further evaluate its safety.
Phase 3: The drug or treatment is given to large groups of people to confirm its effectiveness, monitor side effects, compare it to commonly used treatments, and collect information that will allow the drug or treatment to be used safely.
Phase 4: Studies are done after the drug or treatment has been marketed to gather information on the drug's effect in various populations and any side effects associated with long-term use.

Registry of Acute Stroke Under Novel Oral Anticoagulants - Prime — RASUNOA-Prime

Clinical Trial Summary

Clinical Trial Description

Study Design

Related Conditions & MeSH terms