NOAH – AFNET 6 Trial: Can oral anticoagulation prevent strokes in patients with AHRE?

22.06.2016

Atrial fibrillation (AF) is a common cause of stroke, and it is well established that oral anticoagulation provides efficient stroke prevention in AF patients. However, it is not clear, whether oral anticoagulation is also adequate in the case of atrial high rate episodes (AHRE), an early subclinical manifestation of AF. The Atrial Fibrillation NETwork (AFNET) conducts the investigator initiated NOAH – AFNET 6 trial to evaluate the potential benefit of oral anticoagulation in patients with AHRE, but without overt AF. On June 21st 2016, the first patient was enrolled.

Patients suffering from AF, if documented by an ECG, receive an oral anticoagulation therapy for stroke prevention. However, a large proportion of AF episodes remain undiagnosed (silent AF), and many of these patients present with a stroke as the first clinical sign of AF. Prof. Paulus Kirchhof, Birmingham, chief investigator of the NOAH trial, is sure: “An earlier initiation of anticoagulation could prevent such events. But it is very challenging to detect silent AF at an early stage. Hence, we need this controlled trial to assess whether anticoagulation is beneficial in patients with atrial high rate episodes. Continuous monitoring of atrial rhythm by implanted devices could close this diagnostic gap.”

Prof. Kirchhof explains the background of the trial: “Modern pacemakers and defibrillators provide automated algorithms alerting to the occurrence of atrial high rate episodes (AHRE). These episodes often, but not always correspond to short atrial tachyarrhythmias. There is evidence that the stroke rate is increased in patients with AHRE. A sizeable portion of these patients develop AF over time. In these patients, AHRE can be considered as an early manifestation of AF. There is uncertainty about the optimal antithrombotic therapy in patients with AHRE. Therefore, we conduct the NOAH – AFNET 6 trial.”

NOAH – AFNET 6 is a prospective, parallel-group, randomized, open, double-blind, multi-center trial to evaluate the potential benefit of oral anticoagulation therapy in patients with AHRE, but without overt AF. The trial will test whether treatment with edoxaban, a newly introduced non-vitamin K antagonist oral anticoagulant (NOAC), is superior to current therapy to prevent stroke, systemic embolism, or cardiovascular death in this patient group.

The investigator initiated trial will enroll 3.400 patients with AHRE and at least two stroke risk factors (CHA2DS2VASc Score of 2 or more). Patients are eligible for NOAH, if they have an implanted pace-maker or defibrillator with the feature of detection of AHRE and if their device documented AHRE with an atrial rate of at least 180 bpm and at least 6 min duration. Patients with overt AF are not eligible.

200 - 250 centres in 15 European countries with adequate experience in the follow-up of implanted pacemakers or defibrillators in clinical routine will participate in the pan-European study. The study participants will be randomized to either receiving edoxaban or receiving the best current care consisting of antiplatelet therapy or no therapy depending on the cardiovascular risk.

The NOAH – AFNET 6 trial began as a scientific initiative of AFNET and the European Heart Rhythm Association / European Society of Cardiology (EHRA/ESC). AFNET initiated the NOAH – AFNET 6 trial and bears the overall responsibility. The trial is partially funded by the German Centre for Cardiovascular Research (DZHK). Financial support for the conduct of the trial is provided by Daiichi Sankyo. 

 

About AFNET

The Atrial Fibrillation NETwork (AFNET) is an interdisciplinary research network comprising scientists and physicians from hospitals and practices dedicated to improving the management of atrial fibrillation through coordinated research in Germany, Europe, and the USA. Its main objective is to conduct high quality investigator-initiated clinical trials and registries on a national and international level. The AFNET continues the long-term activities of the network which has been funded by the German Federal Ministry of Research and Education over a decade. Since January 2015, specific projects and infrastructures of the AFNET are funded by the German Centre for Cardiovascular Research (DZHK).

www.af-net.eu

Registration
EudraCT number: 2015-003997-33
ClinicalTrials.gov: NCT02618577

Address
Kompetenznetz Vorhofflimmern e.V. (AFNET)
Mendelstraße 11
48149 Münster
Germany
Phone: +49 251 9801340
info@kompetenznetz-vorhofflimmern.de

Press contact
Angelika Leute, PhD
a.leute@t-online.de
Phone: +49 202 2623395