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Press release
The NOAH – AFNET 6 trial which is conducted to evaluate the potential benefit of oral anticoagulation in patients with atrial high rate episodes (AHRE) is going to be terminated prematurely. The reason for early termination is an observed trend towards futility for efficacy combined with expected safety concerns. Following a recommendation of the study scientific committees, on 2 September 2022, AFNET decided to orderly terminate the NOAH – AFNET6 trial in the coming weeks. The study results will be available next year.
The AFNET is conducting NOAH – AFNET 6 (Non-vitamin K antagonist Oral anticoagulants in patients with AHRE) since 2016 as an investigator-initiated trial in 18 European countries, financially supported by Daiichi Sankyo Europe and the German Centre for Cardiovascular Research (DZHK). Recently the target number of 2538 randomised and treated patients was reached. Early termination of the study means for the participants that they are advised to come timely to the study site for a final visit at which the intake of study medication ends.
It is well established that oral anticoagulation provides effective stroke prevention in patients with Atrial Fibrillation (AF). NOAH – AFNET 6 investigates, whether oral anticoagulation is also adequate in the case of atrial high rate episodes (AHRE), but without overt AF. The trial compares treatment with Edoxaban, a non-vitamin K antagonist oral anticoagulant (NOAC), to current therapy (antiplatelet therapy or no antithrombotic therapy) to prevent stroke, cardiovascular death, or systemic embolism in patients with AHRE aged 65 years or more with at least two stroke risk factors. This is outside the approved indication for Edoxaban. Design and rationale of NOAH – AFNET 6 were published in 2017 (1).
The reasons for early termination given by the Data and Safety Monitoring Board (DSMB) are an observed trend towards futility for efficacy combined with safety concerns. Prof. Paulus Kirchhof, principal investigator of NOAH – AFNET 6 and chairman of the AFNET board, explained: “We have to wait for the analysis of the full data. What we know so far suggests that oral anticoagulation is not as effective as we hoped for in patients with AHRE. On the basis of the available information, AFNET decided that orderly termination of the trial according to study protocol is the best way to fulfil the responsibility towards our patients.”
Prof. Andreas Goette, NOAH – AFNET 6 sponsor representative and member of the AFNET board, stated: “NOAH was designed to find out whether NOAC treatment can reduce the stroke rate significantly. We are already sure that this is not the case. However, there are no unexpected safety concerns visible.”
Prof. Kirchhof concluded: “While the early termination of NOAH is an unexpected development, we are confident that the analysis of the trial data will yield important findings on the optimal antithrombotic therapy for patients with AHRE. We will hopefully be able to report the results next year.”
References
[1] Kirchhof et al, Probing oral anticoagulation in patients with atrial high rate episodes: Rationale and design of the Non–vitamin K antagonist Oral anticoagulants in patients with Atrial High rate episodes (NOAH – AFNET 6) trial, Am Heart J. 2017 Aug;190:12-18.
doi: 10.1016/j.ahj.2017.04.015.
About the Atrial Fibrillation NETwork (AFNET)
The Atrial Fibrillation NETwork 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 worldwide. 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).
Press Contact
Angelika Leute, PhD
Phone: +49 202 2623395
a.leute@t-online.de