Prevent complications

AF Registry - Berlin Cohort Study on Oral Anticoagulation in Patients with Atrial Fibrillation and Acute Ischemic Stroke

The study is an Investigator-initiated, prospective, multi-centre cohort study using the established collaborative group of the Berlin Stroke Register (BSR) to gather data on eligible stroke patients and to investigate in the city of Berlin about the secondary prevention for stroke and the adherence regarding the prescriptions in patients with known atrial fibrillation and ischemic stroke.
More information/project description

Research Group Häusler

Project Description

Berlin AF registry

We are pleased to welcome you on the homepage of the Berlin Atrial Fibrillation Registry of the Charité–Universitätsmedizin Berlin. For the duration of this Berlin-wide, multi-centre registry we will provide you on this website with relevant information and list publications and events regarding the study.  

With kind regards from Berlin,
The Berlin Atrial Fibrillation Registry Team.

Scientific background

Atrial fibrillation (AF) is the most frequent cardiac arrhythmia worldwide and its prevalence increases with age. AF accounts for every fifth ischemic stroke in Germany and patients with AF-related cardio-embolic strokes show a poorer prognosis and a higher recurrence rate compared to stroke patients without AF. Long-term oral anticoagulation with vitamin K antagonists (VKAs) reduces the risk of recurrent stroke in AF patients by about two thirds compared to placebo. However, due to the rather narrow therapeutic window, bleeding complications and multiple drug interactions, VKA are widely underused in routine practice, especially in elderly AF-patients, those with paroxysmal AF, minor falls, dementia or those treated by a general practitioner. Recent national data from Sweden demonstrate that of all stroke patients with AF treated on warfarin at discharge, only 65% followed up at one year and 45% followed up at 2 years are still on this VKA. It emerges from clinical trials that novel oral anticoagulants (NOACs) such as dabigatran, rivaroxaban or apixaban are at least as effective if not more effective compared to the VKA warfarin for the prevention of recurrent stroke, (intracranial) bleeding and even death. National and international guidelines therefore recommend oral anticoagulation using VKAs or NOACs for patients with AF and prior ischemic stroke with the highest level of evidence.

Although NOACs are a reasonable therapeutic alternative to VKAs, their adoption in clinical practice depends, at least to some extent, on their economic practicality. Daily treatment costs for NOACs are higher compared to VKAs, however, clinical effectiveness, lower rates of drug-drug and drug-food interactions and removing the need for serial INR measurements may make them cost-effective in unselected populations as well as in cost-effectiveness modelling based on trial data. Medication non-adherence is a well known clinical problem and may result in a higher rate of cerebrovascular events and cardiovascular death in stroke patients, as similarly described for non-stroke patients. Prospective data including the range of NOACs for secondary prevention outside of clinical trials are missing so far, and ongoing cohorts like RE-LYable and RASUNOVA do not focus on patients´ adherence and/or persistence to oral anticoagulation for secondary stroke prevention. Careful measurement and attention to methodological issues such as the use of validated scales can improve the assessment of self-reported adherence, allowing more accurate conclusions to be drawn about medication-taking behaviour. Resulting information might inform the development of improved interventions that target medication non-adherence. Although there are some data on persistence in selected NOACs in primary prevention, there is currently a lack of data on long term persistence and adherence with the NOACs for secondary prevention of stroke in unselected populations.

Study design

The study is an Investigator-initiated, prospective, multi-centre cohort study using the established collaborative group of the Berlin Stroke Register (BSR) to gather data on eligible stroke patients and to investigate in the city of Berlin about the secondary prevention for stroke and the adherence regarding the prescriptions in patients with known atrial fibrillation and ischemic stroke. More information at  https://clinicaltrials.gov/ct2/show/NCT02306824.

Scientific Board

PD Dr. med. K. G. Häusler (PI) (Center for Stroke Research Berlin)
Prof. Dr. med. M. Endres (Co-PI) (Department of Neurology, Charité)

 

 

Principal Investigator of the “Berlin cohort study on oral anticoagulation in patients with atrial fibrillation and acute ischemic stroke” is assistant professor Dr. K. G. Häusler; the study is conducted through the team of the study headquarters of the Center for Stroke Research Berlin at the Charité - University Hospital and financially supported by Bayer HealthCare, Bayer Vital GmbH.

Team of the study headquarters

PD Dr. Karl Georg Häusler

PD Dr. med. Karl Georg Häusler

Principal Investigator
georg.haeusler(at)charite.de
Phone  +49 30 450 560 663
Fax  +49 30 450 560 979

Claudia Kunze, B.A.

Claudia Kunze, B.A.

Project Manager
c.kunze(at)charite.de
Phone  +49 30 450 560 678
Fax +49 30 450 7 560 916

Petra Dem

Study Assistant
petra.dem(at)charite.de
Phone +49 30 450 560 687

Gesa Nöhren

Monitor
gesa.noehren(at)charite.de
Phone +40 30 450 560 678 
Fax +49 30 450 7 560 916

Johannes Schurig

Investigating Physician
johannes.schurig(at)charite.de
Phone +49 30 450 560 496
Fax +49 30 450 7 560 916

Dr. Joanna Dietzel

Dr. med. Joanna Dietzel

Investigating Physician
joanna.dietzel(at)charite.de
Phone +49 30 450 560 673
Fax +49 30 450 560 979

Dr. med. Serdar Tütüncü

Investigating Physician
serdar.tuetuencue(at)charite.de
Tel. +49 30 450 560 673
Fax +49 30 450 7 560 916

Collaborating research facilities

Implementation of the study was realized in collaboration with 14 study sites encompassing all certified stroke units of Berlin metropolitan area. The initiation phase of the study was completed in June 2015. In this regard, we give thanks to all collaborating clinical study sites for the professional and sincere working climate during the initiation procedure.

Recruitment

Since recruitment initiation in December 2014 the rate of recruitment was increased on a monthly base. As of July 2015, all 14 study sites participate actively in patient recruitment and at the beginning of October 2016 the 1000th participant could be included in the Berlin AF registry. At this point we give our sincere thanks to all actively recruiting study sites for their dedicating work.

Monitoring

The subject matter of monitoring is the control of adherence to the study protocol according to GCP as well as compliance with legal regularities. Furthermore monitoring ensures a high standard of data quality and consequently raises the validity of the study.

Upcoming research meetings

As part of the quarterly scheduled meeting of the Berlin stroke registry (BSR) all directors of the research units are updated about the study progress.

 

 

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